Document text
C4591001 Page 1of 26
CONFIDENTIAL 19-Nov-2020 09:16:13 GMT16.1.3.1 LIST OF INDEPENDENT ETHICS COMMITTEE (IEC) OR INSTITUTIONAL REVIEW BOARD (IRB)
ARGENTINA
Study Site Number Independent Ethics Committee or Institutional Review Board Address(es)
1231 Com itéInstitucional de Revisión de Ensayos Clínicos (C.I.R.E.C.) del Hospital Militar Central
"Cirujano Mayor Dr Cosme Argerich"
Av. Luis María Campos 726, Edificio PACE Piso 5
CABA, 1426
ARGENTINA
090177e1959b69d8\Approved\Approved On: 26-Nov-2020 02:29 (GMT)
Page 1
FDA-CBER-2021-5683-0024494
C4591001 Page 2of 26
CONFIDENTIAL 19-Nov-2020 09:16:13 GMTBRAZIL
Study Site Number Independent Ethics Committee or Institutional Review Board Address(es)
1226 Com ite de Etica em Pesquisa da Faculdade de Medicina do ABC \Fundacao do ABC -- FMABC
Avenida Lauro Gomes, 2000 -Vila Sacadura Cabral
Santo Andre/SP, 09060 -870
BRAZIL
CONEP (Comissao Nacional de Etica em Pesquisa)
SRTV 701, Via W 5 Norte, lote D, Edificio PO 700, 3º andar - Asa Norte
Brasilia, DF 70719 -040
BRAZIL
1241 Com ite de Etica em Pesquisa do Hospital Santo Antonio /Obras Sociais Irma Dulce
Avenida Luiz Tarquí nio, snº, portao 9, 1º andar, sala 1, Roma
Salvador, BA 40414 -120
BRAZIL
CONEP (Comissão Nacional de Ética em Pesquisa)
SRTV 701, Via W 5 Norte, lote D, Edifício PO 700, 3° andar -Asa Norte
Brasília/DF, 70719 -040
BRAZIL
090177e1959b69d8\Approved\Approved On: 26-Nov-2020 02:29 (GMT)
Page 2
FDA-CBER-2021-5683-0024495
C4591001 Page 3of 26
CONFIDENTIAL 19-Nov-2020 09:16:13 GMTGERMANY
Study Site Number Independent Ethics Committee or Institutional Review Board Address(es)
1185 Landesaerztekammer Baden -Wuerttemberg
Liebknechtstr. 33
Stuttgart, 70565
GERMANY
1194 Landesaerztekammer Baden -Wuerttemberg
Liebknechtstr. 33
Stuttgart, 70565
GERMANY
1195 Landesaerztekammer Baden -Wuerttemberg
Liebknechtstr. 33
Stuttgart, 70565
GERMANY
1197 Landesaerztekammer Baden -Wuerttemberg
Liebknechtstr. 33
Stuttgart, 70565
GERMANY
1202 Landesaerztekammer Baden -Wuerttemberg
Liebknechtstr. 33
Stuttgart, 70565
GERMANY
1203 Landesaerztekammer Baden -Wuerttemberg
Liebknechtstr. 33
Stuttgart, 70565
GERMANY
090177e1959b69d8\Approved\Approved On: 26-Nov-2020 02:29 (GMT)
Page 3
FDA-CBER-2021-5683-0024496
C4591001 Page 4of 26
CONFIDENTIAL 19-Nov-2020 09:16:13 GMTSOUTH AFRICA
Study Site Number Independent Ethics Committee or Institutional Review Board Address(es)
1229 Pharm a Ethics Independent Research Ethics committee
123 Amcor Road, Lyttelton Manor
Centurion, 0157
SOUTH AFRICA
1230 Pharm a-Ethics (Pty) Ltd
123 Amkor Road, Lyttelton Manor
Centurion, 0157
SOUTH AFRICA
1246 Pharm a-Ethics (Pty) Ltd
123 Amkor Road, Lyttelton Manor
Centurion, 0157
SOUTH AFRICA
1247 Pharm a-Ethics (Pty) Ltd
123 Amkor Road, Lyttelton Manor
Centurion, 0157
SOUTH AFRICA
090177e1959b69d8\Approved\Approved On: 26-Nov-2020 02:29 (GMT)
Page 4
FDA-CBER-2021-5683-0024497
C4591001 Page 5of 26
CONFIDENTIAL 19-Nov-2020 09:16:13 GMTTURKEY
Study Site Number Independent Ethics Committee or Institutional Review Board Address(es)
1205 Kocaeli Üniversitesi Klinik Arastirmalar Etik Kurulu
Kocaeli Ü niversitesi Tip Fakültesi Klinik, Arastirmalar Birimi Umuttepe Yerleskesi
Kocaeli
TURKEY
1207 Kocaeli Üniversitesi Klinik Arastirmalar Etik Kurulu
Kocaeli Üniversitesi Tip Fakültesi Klinik, Arastirmalar Birimi Umuttepe Yerleskesi
Kocaeli
TURKEY
1208 Kocaeli Üniversitesi Klinik Arastirmalar Etik Kurulu
Kocaeli Üniversitesi Tip Fakültesi Klinik, Arastirmalar Birimi Umuttepe Yerleskesi
Kocaeli
TURKEY
1209 Kocaeli Üniversitesi Klinik Arastirmalar Etik Kurulu
Kocaeli Üniversitesi Tip Fakü ltesi Klinik, Arastirmalar Birimi Umuttepe Yerleskesi
Kocaeli
TURKEY
1210 Kocaeli Üniversitesi Klinik Arastirmalar Etik Kurulu
Kocaeli Üniversitesi Tip Fakültesi Klinik, Arastirmalar Birimi Umuttepe Yerleskesi
Kocaeli
TURKEY
1212 Kocaeli Ü niversitesi Klinik Arastirmalar Etik Kurulu
Kocaeli Üniversitesi Tip Fakültesi Klinik, Arastirmalar Birimi Umuttepe Yerleskesi
Kocaeli
TURKEY
1213 Kocaeli Üniversitesi Klinik Arastirmalar Etik Kurulu
Kocaeli Üniversitesi Tip Fakültesi Klinik, Arastirmalar Birimi Umuttepe Yerleskesi
Kocaeli
TURKEY
090177e1959b69d8\Approved\Approved On: 26-Nov-2020 02:29 (GMT)
Page 5
FDA-CBER-2021-5683-0024498
C4591001 Page 6of 26
CONFIDENTIAL 19-Nov-2020 09:16:13 GMTStudy Site Number Independent Ethics Committee or Institutional Review Board Address(es)
1214 Kocaeli Üniversitesi Klinik Arastirmalar Etik Kurulu
Kocaeli Üniversitesi Tip Fakültesi Klinik, Arastirmalar Birimi Umuttepe Yerleskesi
Kocaeli
TURKEY
1217 Kocaeli Üniversitesi Klinik Arastirmalar Et ik Kurulu
Kocaeli Üniversitesi Tip Fakültesi Klinik, Arastirmalar Birimi Umuttepe Yerleskesi
Kocaeli
TURKEY
090177e1959b69d8\Approved\Approved On: 26-Nov-2020 02:29 (GMT)
Page 6
FDA-CBER-2021-5683-0024499
C4591001 Page 7of 26
CONFIDENTIAL 19-Nov-2020 09:16:13 GMTUNITED STATES
Study Site Number Independent Ethics Committee or Institutional Review Board Address(es)
1001 NYU Langone Grossman School of Medicine IRB
One Park Ave, 6th Fl
New York, NY 10016
UNITED STATES
1002 Western Institutional Review Board
1019 39th Ave., SE, Ste 120
Puyallup, WA 98374
UNITED STATES
1003 Western Institutional Review Board
1019 39th Ave SE, Ste 120
Puyallup, WA 98374
UNITED STATES
1005 Copernicus Group Institutional Revie w Board
5000 CentreGreen Way, Ste 200
Cary, NC 27513
UNITED STATES
1006 Copernicus Group Institutional Revie w Board
5000 CentreGreen Way, Ste 200
Cary, NC 27513
UNITED STATES
1007 Cincinnati Children’s Hospital Medical Center IRB
3333 Burnet Ave, MLC 5020
Cincinnati, OH 45229
UNITED STATES
1008 Copernicus Group Institutional Revie w Board
5000 CentreGreen Way, Ste 200
Cary, NC 27513
UNITED STATES
090177e1959b69d8\Approved\Approved On: 26-Nov-2020 02:29 (GMT)
Page 7
FDA-CBER-2021-5683-0024500
C4591001 Page 8of 26
CONFIDENTIAL 19-Nov-2020 09:16:13 GMTStudy Site Number Independent Ethics Committee or Institutional Review Board Address(es)
1009 Copernicus Group Institutional Revie w Board
5000 CentreGreen Way, Ste 200
Cary, NC 27513
UNITED STATES
1011 Copernicus Group Institutional Revie w Board
5000 CentreGreen Way, Ste 200
Cary, NC 27513
UNITED STATES
1012 Copernicus Group Institutional Revie w Board
5000 CentreGreen Way, Ste 200
Cary, NC 27513
UNITED STATES
1013 Copernicus Group IRB
5000 Centregreen Way, Ste 200
Cary, NORTH CAROLINA 27513
UNITED STATES
Western Institutional Review Board (WIRB)
1019 39th Ave Se, Ste 120
Puyallup, WASHINGTON 98374
UNITED STATES
1015 Western Institutional Review Board (WIRB)
1019 39th Ave Se, Ste 120
Puyallup, WASHINGTON 98374
UNITED STATES
1016 Copernicus Group Institutional Revie w Board
5000 CentreGreen Way, Ste 200
Cary, NC 27513
UNITED STATES
090177e1959b69d8\Approved\Approved On: 26-Nov-2020 02:29 (GMT)
Page 8
FDA-CBER-2021-5683-0024501
C4591001 Page 9of 26
CONFIDENTIAL 19-Nov-2020 09:16:13 GMTStudy Site Number Independent Ethics Committee or Institutional Review Board Address(es)
1018 Copernicus Group Institutional Revie w Board
5000 CentreGreen Way, Ste 200
Cary, NC 27513
UNITED STATES
1019 Copernicus Group IRB
5000 CentreGreen Way, Ste 200
Cary, NORTH CAROLINA 27513
UNITED STATES
1021 Copernicus Group IRB
5000 Centregreen Way, Ste 200
Cary, NORTH CAROLINA 27513
UNITED STATES
1022 Copernicus Group Institutional Revie w Board
5000 CentreGreen Way, Ste 200
Cary, NC 27513
UNITED STATES
1024 Copernicus Group Institutional Revie w Board
5000 CentreGreen Way, Ste 200
Cary, NC 27513
UNITED STATES
1027 Copernicus Group Institutional Revie w Board
5000 CentreGreen Way, Ste 200
Cary, NC 27513
UNITED STATES
1028 Copernicus Group IRB
5000 Centregreen Way, Ste 200
Cary, NORTH CAROLINA 27513
UNITED STATES
090177e1959b69d8\Approved\Approved On: 26-Nov-2020 02:29 (GMT)
Page 9
FDA-CBER-2021-5683-0024502
C4591001 Page 10of 26
CONFIDENTIAL 19-Nov-2020 09:16:13 GMTStudy Site Number Independent Ethics Committee or Institutional Review Board Address(es)
1030 Copernicus Group Institutional Revie w Board
5000 CentreGreen Way, Ste 200
Cary, NC 27513
UNITED STATES
1036 Copernicus Group Institutional Revie w Board
5000 CentreGreen Way, Ste 200
Cary, NC 27513
UNITED STATES
1037 Western Institutional Review Board (WIRB)
1019 39th Ave Se, Ste 120
Puyallup, WASHINGTON 98374
UNITED STATES
Copernicus Group IRB
5000 Centregreen Way, Ste 200
Cary, NORTH CAROLINA 27513
UNITED STATES
1038 Copernicus Group Institutional Revie w Board
5000 CentreGreen Way, Ste 200
Cary, NC 27513
UNITED STATES
1039 Copernicus Group Institutional Revie w Board
5000 CentreGreen Way, Ste 200
Cary, NC 27513
UNITED STATES
1042 Copernicus Group IRB
5000 Centregreen Way, Ste 200
Cary, NORTH CAROLINA 27513
UNITED STATES
090177e1959b69d8\Approved\Approved On: 26-Nov-2020 02:29 (GMT)
Page 10
FDA-CBER-2021-5683-0024503
C4591001 Page 11of 26
CONFIDENTIAL 19-Nov-2020 09:16:13 GMTStudy Site Number Independent Ethics Committee or Institutional Review Board Address(es)
1044 Copernicus Group Institutional Revie w Board
5000 CentreGreen Way, Ste 200
Cary, NC 27513
UNITED STATES
1046 Copernicus Group IRB
5000 Centregreen Way, Ste 200
Cary, NORTH CAROLINA 27513
UNITED STATES
1047 Copernicus Group Institutional Revie w Board
5000 CentreGreen Way, Ste 200
Cary, NC 27513
UNITED STATES
1048 Copernicus Group Institutional Revie w Board
5000 CentreGreen Way, Ste 200
Cary, NC 27513
UNITED STATES
1052 Copernicus Group Institutional Revie w Board
5000 CentreGreen Way, Ste 200
Cary, NC 27513
UNITED STATES
1054 Copernicus Group Institutional Revie w Board
5000 CentreGreen Way, Ste 200
Cary, NC 27513
UNITED STATES
1055 Copernicus Group Institutional Revie w Board
5000 CentreGreen Way, Ste 200
Cary, NC 27513
UNITED STATES
090177e1959b69d8\Approved\Approved On: 26-Nov-2020 02:29 (GMT)
Page 11
FDA-CBER-2021-5683-0024504
C4591001 Page 12of 26
CONFIDENTIAL 19-Nov-2020 09:16:13 GMTStudy Site Number Independent Ethics Committee or Institutional Review Board Address(es)
1056 Copernicus Group Institutional Revie w Board
5000 Centregreen Way, Ste 200
Cary, NORTH CAROLINA 27513
UNITED STATES
1057 Western Institutional Review Board (WIRB)
1019 39th Ave Se, Ste 120
Puyallup, WASHINGTON 98374
UNITED STATES
Copernicus Group IRB
5000 Centregreen Way, Ste 200
Cary, NORTH CAROLINA 27513
UNITED STATES
1066 Copernicus Group Institutional Revie w Board
5000 CentreGreen Way, Ste 200
Cary, NC 27513
UNITED STATES
1068 Copernicus Group Institutional Revie w Board
5000 CentreGreen Way, Ste 200
Cary, NC 27513
UNITED STATES
1071 Copernicus Group Institutional Revie w Board
5000 CentreGreen Way, Ste 200
Cary, NC 27513
UNITED STATES
1072 Copernicus Group Institutional Revie w Board
5000 CentreGreen Way, Ste 200
Cary, NC 27513
UNITED STATES
090177e1959b69d8\Approved\Approved On: 26-Nov-2020 02:29 (GMT)
Page 12
FDA-CBER-2021-5683-0024505
C4591001 Page 13of 26
CONFIDENTIAL 19-Nov-2020 09:16:13 GMTStudy Site Number Independent Ethics Committee or Institutional Review Board Address(es)
1073 Copernicus Group Institutional Revie w Board
5000 CentreGreen Way, Ste 200
Cary, NC 27513
UNITED STATES
1077 Copernicus Group Institutional Revie w Board
5000 CentreGreen Way, Ste 200
Cary, NC 27513
UNITED STATES
1079 Copernicus Group Institutional Revie w Board
5000 CentreGreen Way, Ste 200
Cary, NC 27513
UNITED STATES
1080 Copernicus Group IRB
5000 Centregreen Way, Ste 200
Cary, NORTH CAROLINA 27513
UNITED STATES
1081 Copernicus Group Institutional Revie w Board
5000 CentreGreen Way, Ste 200
Cary, NC 27513
UNITED STATES
1082 Copernicus Group Institutional Revie w Board
5000 CentreGreen Way, Ste 200
Cary, NC 27513
UNITED STATES
1083 Copernicus Group Institutional Revie w Board
5000 CentreGreen Way, Ste 200
Cary, NC 27513
UNITED STATES
090177e1959b69d8\Approved\Approved On: 26-Nov-2020 02:29 (GMT)
Page 13
FDA-CBER-2021-5683-0024506
C4591001 Page 14of 26
CONFIDENTIAL 19-Nov-2020 09:16:13 GMTStudy Site Number Independent Ethics Committee or Institutional Review Board Address(es)
1084 Copernicus Group Institutional Revie w Board
5000 CentreGreen Way, Ste 200
Cary, NC 27513
UNITED STATES
1085 Copernicus Group IRB
5000 CentreGreen Way, Ste 200
Cary, NC 27513
UNITED STATES
1087 Copernicus Group Institutional Revie w Board
5000 CentreGreen Way, Ste 200
Cary, NC 27513
UNITED STATES
1088 Copernicus Group Institutional Revie w Board
5000 CentreGreen Way, Ste 200
Cary, NC 27513
UNITED STATES
1089 Copernicus Group IRB
5000 Centregreen Way, Ste 200
Cary, NORTH CAROLINA 27513
UNITED STATES
1090 Copernicus Group IRB
5000 Centregreen Way, Ste 200
Cary, NORTH CAROLINA 27513
UNITED STATES
1091 Copernicus Group IRB
5000 Centregreen Way, Ste 200
Cary, NORTH CAROLINA 27513
UNITED STATES
090177e1959b69d8\Approved\Approved On: 26-Nov-2020 02:29 (GMT)
Page 14
FDA-CBER-2021-5683-0024507
C4591001 Page 15of 26
CONFIDENTIAL 19-Nov-2020 09:16:13 GMTStudy Site Number Independent Ethics Committee or Institutional Review Board Address(es)
1092 Copernicus Group Institutional Revie w Board
5000 CentreGreen Way, Ste 200
Cary, NC 27513
UNITED STATES
1093 Copernicus Group IRB
5000 Centregreen Way, Ste 200
Cary, NORTH CAROLINA 27513
UNITED STATES
1094 Copernicus Group Institutional Revie w Board
5000 CentreGreen Way, Ste 200
Cary, NC 27513
UNITED STATES
1095 Copernicus Group Institutional Revie w Board
5000 CentreGreen Way, Ste 200
Cary, NC 27513
UNITED STATES
1096 Copernicus Group IRB
5000 CentreGreen Way, Ste 200
Cary, NC 27513
UNITED STATES
1097 Copernicus Group Institutional Revie w Board
5000 CentreGreen Way, Ste 200
Cary, NC 27513
UNITED STATES
1098 Copernicus Group Institutional Revie w Board
5000 Centregreen Way, Ste 200
Cary, NORTH CAROLINA 27513
UNITED STATES
090177e1959b69d8\Approved\Approved On: 26-Nov-2020 02:29 (GMT)
Page 15
FDA-CBER-2021-5683-0024508
C4591001 Page 16of 26
CONFIDENTIAL 19-Nov-2020 09:16:13 GMTStudy Site Number Independent Ethics Committee or Institutional Review Board Address(es)
1101 Copernicus Group Institutional Revie w Board
5000 CentreGreen Way, Ste 200
Cary, NC 27513
UNITED STATES
1107 Copernicus Group Institutional Revie w Board
5000 CentreGreen Way, Ste 200
Cary, NC 27513
UNITED STATES
1109 Copernicus Group IRB
5000 CentreGreen Way, Ste 200
Cary, NORTH CAROLINA 27513
UNITED STATES
1110 Copernicus Group IRB
5000 Centregreen Way, Ste 200
Cary, NORTH CAROLINA 27513
UNITED STATES
1111 Copernicus Group Institutional Revie w Board
5000 CentreGreen Way, Ste 200
Cary, NC 27513
UNITED STATES
1112 Copernicus Group Institutional Revie w Board
5000 CentreGreen Way, Ste 200
Cary, NC 27513
UNITED STATES
1114 Copernicus Group Institutional Revie w Board
5000 CentreGreen Way, Ste 200
Cary, NC 27513
UNITED STATES
090177e1959b69d8\Approved\Approved On: 26-Nov-2020 02:29 (GMT)
Page 16
FDA-CBER-2021-5683-0024509
C4591001 Page 17of 26
CONFIDENTIAL 19-Nov-2020 09:16:13 GMTStudy Site Number Independent Ethics Committee or Institutional Review Board Address(es)
1116 Copernicus Group Institutional Revie w Board
5000 CentreGreen Way, Ste 200
Cary, NC 27513
UNITED STATES
1117 Copernicus Group Institutional Revie w Board
5000 CentreGreen Way, Ste 200
Cary, NC 27513
UNITED STATES
1118 Copernicus Group Institutional Revie w Board
5000 Centregreen Way, Ste 200
Cary, NORTH CAROLINA 27513
UNITED STATES
1120 Copernicus Group Institutional Revie w Board
5000 CentreGreen Way, Ste 200
Cary, NC 27513
UNITED STATES
1121 Copernicus Group Institutional Revie w Board
5000 CentreGreen Way, Ste 200
Cary, NC 27513
UNITED STATES
1122 WESTERN INSTITUTIONAL REVIEW BOARD
1019 39th Ave S.E, Ste 120
Puyallup, WA 98374
UNITED STATES
1123 Copernicus Group Institutional Revie w Board
5000 CentreGreen Way, Ste 200
Cary, NC 27513
UNITED STATES
090177e1959b69d8\Approved\Approved On: 26-Nov-2020 02:29 (GMT)
Page 17
FDA-CBER-2021-5683-0024510
C4591001 Page 18of 26
CONFIDENTIAL 19-Nov-2020 09:16:13 GMTStudy Site Number Independent Ethics Committee or Institutional Review Board Address(es)
1124 Copernicus Group Institutional Revie w Board
5000 CentreGreen Way, Ste 200
Cary, NC 27513
UNITED STATES
1125 Copernicus Group Institutional Revie w Board
5000 CentreGreen Way, Ste 200
Cary, NC 27513
UNITED STATES
1126 Kaiser Permanente Northern California Institutional Review Board
1800 Harrison St, 10th Fl
Oakland, CA 94612
UNITED STATES
1127 Copernicus Group Institutional Revie w Board
5000 CentreGreen Way, Ste 200
Cary, NC 27513
UNITED STATES
1128 Copernicus Group IRB
5000 CentreGreen Way, Ste 200
Cary, NC 27513
UNITED STATES
1129 Copernicus Group Institutional Revie w Board
5000 CentreGreen Way, Ste 200
Cary, NC 27513
UNITED STATES
1130 Copernicus Group IRB
5000 Centregreen Way, Ste 200
Cary, NORTH CAROLINA 27513
UNITED STATES
090177e1959b69d8\Approved\Approved On: 26-Nov-2020 02:29 (GMT)
Page 18
FDA-CBER-2021-5683-0024511
C4591001 Page 19of 26
CONFIDENTIAL 19-Nov-2020 09:16:13 GMTStudy Site Number Independent Ethics Committee or Institutional Review Board Address(es)
1131 Copernicus Group Institutional Revie w Board
5000 CentreGreen Way, Ste 200
Cary, NC 27513
UNITED STATES
1133 Copernicus Group Institutional Revie w Board
5000 CentreGreen Way, Ste 200
Cary, NC 27513
UNITED STATES
1134 Copernicus Group Institutional Revie w Board
5000 CentreGreen Way, Ste 200
Cary, NC 27513
UNITED STATES
1135 Copernicus Group IRB
5000 Centregreen Way, Ste 200
Cary, NORTH CAROLINA 27513
UNITED STATES
1136 Copernicus Group Institutional Revie w Board
5000 CentreGreen Way, Ste 200
Cary, NC 27513
UNITED STATES
1139 WESTERN INSTITUTIONAL REVIEW BOARD
1019 39th Ave SE, Ste 120
Puyallup, WASHINGTON 98374 -2115
UNITED STATES
1140 WESTERN INSTITUTIONAL REVIEW BOARD
1019 39th Ave S.E, Ste 120
Puyallup, WA 98374
UNITED STATES
090177e1959b69d8\Approved\Approved On: 26-Nov-2020 02:29 (GMT)
Page 19
FDA-CBER-2021-5683-0024512
C4591001 Page 20of 26
CONFIDENTIAL 19-Nov-2020 09:16:13 GMTStudy Site Number Independent Ethics Committee or Institutional Review Board Address(es)
1141 Western Institutional Review Board
1019 39th Ave SE, Ste 120
Puyallup, WASHINGTON 98374
UNITED STATES
1142 Copernicus Group IRB
5000 CentreGreen Way, Ste 200
Cary, NORTH CAROLINA 27513
UNITED STATES
1145 Copernicus Group Institutional Revie w Board
5000 CentreGreen Way, Ste 200
Cary, NC 27513
UNITED STATES
1146 Copernicus Group Institutional Revie w Board
5000 CentreGreen Way, Ste 200
Cary, NC 27513
UNITED STATES
1147 Western Institutional Review Board (WIRB)
1019 39th Ave Se, Ste 120
Puyallup, WASHINGTON 98374
UNITED STATES
1149 Copernicus Group IRB
5000 Centregreen Way, Ste 200
Cary, NORTH CAROLINA 27513
UNITED STATES
1150 Copernicus Group Institutional Revie w Board
5000 CentreGreen Way, Ste 200
Cary, NC 27513
UNITED STATES
090177e1959b69d8\Approved\Approved On: 26-Nov-2020 02:29 (GMT)
Page 20
FDA-CBER-2021-5683-0024513
C4591001 Page 21of 26
CONFIDENTIAL 19-Nov-2020 09:16:13 GMTStudy Site Number Independent Ethics Committee or Institutional Review Board Address(es)
1152 Copernicus Group IRB
5000 Centregreen Way, Ste 200
Cary, NORTH CAROLINA 27513
UNITED STATES
1156 Copernicus Group Institutional Revie w Board
5000 CentreGreen Way, Ste 200
Cary, NC 27513
UNITED STATES
1157 Copernicus Group Institutional Revie w Board
5000 CentreGreen Way, Ste 200
Cary, NC 27513
UNITED STATES
1161 Copernicus Group Institutional Revie w Board
5000 CentreGreen Way, Ste 200
Cary, NC 27513
UNITED STATES
1162 Copernicus Group Institutional Revie w Board
5000 CentreGreen Way, Ste 200
Cary, NC 27513
UNITED STATES
1163 Copernicus Group IRB
5000 CentreGreen Way, Ste 200
Cary, NORTH CAROLINA 27513
UNITED STATES
1166 Copernicus Group Institutional Revie w Board
5000 CentreGreen Way, Ste 200
Cary, NC 27513
UNITED STATES
090177e1959b69d8\Approved\Approved On: 26-Nov-2020 02:29 (GMT)
Page 21
FDA-CBER-2021-5683-0024514
C4591001 Page 22of 26
CONFIDENTIAL 19-Nov-2020 09:16:13 GMTStudy Site Number Independent Ethics Committee or Institutional Review Board Address(es)
1167 Copernicus Group Institutional Revie w Board
5000 CentreGreen Way, Ste 200
Cary, NC 27513
UNITED STATES
1168 Copernicus Group Institutional Revie w Board
5000 CentreGreen Way, Ste 200
Cary, NC 27513
UNITED STATES
1169 Lehigh Valley Health Network/Institutional Review Board/Research Participant Office
1255 S Cedar Crest Blvd, Ste 3200
Allentown, PA 18103
UNITED STATES
1170 Copernicus Group Institutional Revie w Board
5000 CentreGreen Way, Ste 200
Cary, NC 27513
UNITED ST ATES
1171 Copernicus Group Institutional Revie w Board
5000 Centregreen Way, Ste 200
Cary, NORTH CAROLINA 27513
UNITED STATES
1174 Copernicus Group Institutional Revie w Board
5000 CentreGreen Way, Ste 200
Cary, NC 27513
UNITED STATES
1177 Copernicus Group Institutional Revie w Board
5000 CentreGreen Way, Ste 200
Cary, NC 27513
UNITED STATES
090177e1959b69d8\Approved\Approved On: 26-Nov-2020 02:29 (GMT)
Page 22
FDA-CBER-2021-5683-0024515
C4591001 Page 23of 26
CONFIDENTIAL 19-Nov-2020 09:16:13 GMTStudy Site Number Independent Ethics Committee or Institutional Review Board Address(es)
1178 Copernicus Group Institutional Revie w Board
5000 CentreGreen Way, Ste 200
Cary, NC 27513
UNITED STATES
1179 Copernicus Group IRB
5000 Centregreen Way, Ste 200
Cary, NORTH CAROLINA 27513
UNITED STATES
1204 Western Institutional Review Board
1019 39th Ave SE, Ste 200
Puyallup, WA 98374 -2115
UNITED STATES
1218 Indian Health Service National IRB
5600 Fishers Ln, MS 09E10D
Rockville, MARYLAND 20857
UNITED STATES
Johns Hopkins Bloomberg School of Public Health
615 N. Wolfe St, Rm E1100
Baltimore, MARYLAND 21205
UNITED STATES
1219 Johns Hopkins Bloomberg School of Public Health
615 N. Wolfe St, Rm E1100
Baltimore, MARYLAND 21205
UNITED STATES
Navajo Nation Human Research Review Board
Window Rock Blvd, Administration Bldg #2, Division of Health, P.O. Box 1390
Window Rock, ARIZONA 86515
UNITED STATES
090177e1959b69d8\Approved\Approved On: 26-Nov-2020 02:29 (GMT)
Page 23
FDA-CBER-2021-5683-0024516
C4591001 Page 24of 26
CONFIDENTIAL 19-Nov-2020 09:16:13 GMTStudy Site Number Independent Ethics Committee or Institutional Review Board Address(es)
1220 Johns Hopkins Bloomberg School of Public Health
615 N. Wolfe St, Rm E1100
Baltimore, MARYLAND 21205
UNITED STATES
Navajo Nation Human Research Review Board
Window Rock Blvd, Administration Bldg #2, Division of Health, P.O. Box 1390
Window Rock, ARIZONA 86515
UNITED STATES
1221 Johns Hopkins Bloomberg School of Public Health
615 N. Wolfe St, Rm E1100
Baltimore, MARYLAND 21205
UNITED STATES
Navajo Nation Human Research Review Board
Window Rock Blvd, Administration Bldg #2, Division of Health, P.O. Box 1390
Window Rock, ARIZONA 86515
UNITED STATES
1223 Yale University Human Research Protection Program (Human Investigation Committee)
25 Science Park, 3rd Fl, 150 Munson St
New Haven, CT 06520
UNITED STATES
1224 Copernicus Group IRB
5000 Centregreen Way, Ste 200
Cary, NORTH CAROLINA 27513
UNITED STATES
1232 Copernicus Group Institutional Revie w Board
5000 CentreGreen Way, Ste 200
Cary, NC 27513
UNITED STATES
090177e1959b69d8\Approved\Approved On: 26-Nov-2020 02:29 (GMT)
Page 24
FDA-CBER-2021-5683-0024517
C4591001 Page 25of 26
CONFIDENTIAL 19-Nov-2020 09:16:13 GMTStudy Site Number Independent Ethics Committee or Institutional Review Board Address(es)
1235 Western Institutional Review Board
1019 39th Ave. SE, Ste 120
Puyallup, WA 98374
UNITED STATES
1248 Copernicus Group Institutional Revie w Board
5000 CentreGreen Way, Ste 200
Cary, NC 27513
UNITED STATES
1251 Copernicus Group Institutional Revie w Board
5000 CentreGreen Way, Ste 200
Cary, NC 27513
UNITED STATES
1252 Copernicus Group Institutional Revie w Board
5000 Centregreen Way, Ste 200
Cary, NORTH CAROLINA 27513
UNITED STATES
1254 Copernicus Group Institutional Revie w Board
5000 CentreGreen Way, Ste 200
Cary, NC 27513
UNITED STATES
1258 Copernicus Group Institutional Revie w Board
5000 CentreGreen Way, Ste 200
Cary, NC 27513
UNITED STATES
1260 Western Institutional Review Board
1019 39th Ave SE, Ste 120
Puyallup, WA 98374
UNITED STATES
090177e1959b69d8\Approved\Approved On: 26-Nov-2020 02:29 (GMT)
Page 25
FDA-CBER-2021-5683-0024518
C4591001 Page 26of 26
CONFIDENTIAL 19-Nov-2020 09:16:13 GMTStudy Site Number Independent Ethics Committee or Institutional Review Board Address(es)
1261 Copernicus Group Institutional Revie w Board
5000 CentreGreen Way, Ste 200
Cary, NC 27513
UNITED STATES
1264 Western Institutional Review Board
1019 39th Ave SE, Ste 120
Puyallup, WA 98374
UNITED STATES
1265 Copernicus Group Institutional Revie w Board
5000 CentreGreen Way, Ste 200
Cary, NC 27513
UNITED STATES
1269 Copernicus Group Institutional Revie w Board
5000 CentreGreen Way, Ste 200
Cary, NC 27513
UNITED STATES
1270 Kaiser Permanente Northern California Institutional Review Board
1800 Harrison St, 10th Fl
Oakland, CA 94612
UNITED STATES
090177e1959b69d8\Approved\Approved On: 26-Nov-2020 02:29 (GMT)
Page 26
FDA-CBER-2021-5683-0024519
CT05 -GSOP -
SD-GL11 1.0 PHASE 1/2/3 CLINICAL STUDY ASSENT
TEMPLATE FOR OLDER CHILDREN 30-Apr-2020
Protocol Number: C4591001 Assent Version Date : Phase 2/3, 07Oct2020
Study
Country
Site Language: English Center ID: Not Applicable
Country: Not Applicable
Assent Derived From: Older Children Assent, Phase 2/3, 09Sep2020
CT05 -GSOP -SD-GL11 Phase 1/2/3/4 Clinical Study Assent Template for Older Children 30 -Apr-2020
TMF Doc ID: 173.16 (Study); 173.10 (Country/Central); 173.20 (Site)
Sponsor Assent Version Number (Study/Country/Site) : Phase 2/3 , 07October 2020
Protocol No. C4591001 CONFIDENTIAL Page 1
of 9
• This template is used by informed consent document authors to develop the assent document for
11-year-olds through legal age of adulthood .
• Do not delete the header at the top of this page until the assent is customized at the country/site -
level.
• Before sending the assent to the institutional review board (IRB) /independent ethics committee
(IEC) , remove the header at the top of this page, rem ove all inapplicable text, remove all
instructional green text, and replace all blue text with appropriate language.
• The assent must be filed in the Pfizer Trial Master File .
090177e1952b5e4a\Approved\Approved On: 07-Oct-2020 22:21 (GMT)
Page 27
FDA-CBER-2021-5683-0024520
CT05 -GSOP -
SD-GL11 1.0 PHASE 1/2/3 CLINICAL STUDY ASSENT
TEMPLATE FOR OLDER CHILDREN 30-Apr-2020
Protocol Number: C4591001 Assent Version Date : Phase 2/3, 07Oct2020
Study
Country
Site Language: English Center ID: Not Applicable
Country: Not Applicable
Assent Derived From: Older Children Assent, Phase 2/3, 09Sep2020
CT05 -GSOP -SD-GL11 Phase 1/2/3/4 Clinical Study Assent Template for Older Children 30 -Apr-2020
TMF Doc ID: 173.16 (Study); 173.10 (Country/Central); 173.20 (Site)
Sponsor Assent Version Number (Study/Countr y/Site) : Phase 2/3 , 07October 2020
Protoc ol No. C4591001 CONFIDENTIAL Page 2
of 9
We are asking if you would like to be in a research study to see if a vaccine to prevent
COVID -19 is safe and if it can help prevent children and adults from getting COVID -19.
Research studies are the way we find out if test medicines or vaccines are safe and if they
work.
The study is being done with healthy children and adults and that is why the study doctor
wants to know if you want to take part in the research study .
WHY ARE WE DOING THIS STUDY ?
We are doing this study to collect information in children and adults to see if the vaccine is
safe and if it can help prevent people from getting COVID -19.
The study doctor and nurses will explain the study and answer any questions that you have.
You can circle or highlight things on this paper you want to know more about. If you don’t
understand something, just ask us. It is okay to ask questions now and anytime later that you
think of them.
If you decide to be in this study, you will be asked to sign this form. Your parent(s) or your
guardian(s ) will sign another form. You can talk to your parent(s) or your guardian(s) and ask
to read the information the study doctor gives them .
WHAT WILL HAPPEN TO ME IF I GO INTO THE STUDY ?
The study starts with a n appointment with the study doctor and some tests to see if you can
be in the study. If you decide to take part in the study you will be given an injection in your
arm at your first and second visit and will need to give at least 5 blood samples. There will be
at least 6 visits to the study clinic over roughly the next 2 years.
If you get ill with COVID -19 like symp toms you will need to visit the study clinic and give
another blood sample. This blood sample is 20 mL if you are 16 years of age or above , and it
is 10 mL if you are between 12 to 15 years of age . If you would like to know what 10 mL or 20
mL looks like please ask and the study team and they will be able to show you the tubes they
will col lect the blood in.
090177e1952b5e4a\Approved\Approved On: 07-Oct-2020 22:21 (GMT)
Page 28
FDA-CBER-2021-5683-0024521
CT05 -GSOP -
SD-GL11 1.0 PHASE 1/2/3 CLINICAL STUDY ASSENT
TEMPLATE FOR OLDER CHILDREN 30-Apr-2020
Protocol Number: C4591001 Assent Version Date : Phase 2/3, 07Oct2020
Study
Country
Site Language: English Center ID: Not Applicable
Country: Not Applicable
Assent Derived From: Older Children Assent, Phase 2/3, 09Sep2020
CT05 -GSOP -SD-GL11 Phase 1/2/3/4 Clinical Study Assent Template for Older Children 30 -Apr-2020
TMF Doc ID : 173.16 (Study); 173.10 ( Country/Central); 173.20 (Site)
Sponsor Assent Version Number (Study/Cou ntry/Site) : Phase 2/3 , 07October 2020
Protocol No. C4591001 CONFIDENTIAL Page 3
of 9
At your first visit, the study doctor or nurse will give you or your parent(s) / guardian (s) a
device (a bit like a mobile phone) or ask to download an application ( ‘app’) to smart phone if
you or your parent(s)/ guardian (s) have one. The device/app is secure and your information
will be maintained in con fidence. The study doctor will show you or your parent(s)/
guardian(s) on how to fill in the electronic diary (also called e -Diary).
There are 2 parts to the electronic diary . Everyone will need to complete the COVID -19
illness part of the e -Diary on the device or app on their smartphone. The COVID -19 illness e -
Diary will prompt you or your parent(s)/ guardian(s) to record any COVID -19 symptoms every
7 days or at any time you have COVID -19 symptoms. You or your parent(s)/ guardian(s) may
also receive text messages to your / their device or your / their own smartphone, or emails (if
you or your parent(s)/ guardian(s) provide an email addre ss) to remind you or your parent(s)/
guardian(s) to complete the COVID -19 illness part of the e -Diary.
If you are part of a selected group of participants , you or your parent(s)/ guardian (s) will also
be asked to fill in an e-Diary about how you are feeling for 7 days afer your vaccine injections .
If you decide the take part t he following will happen:
At your first visit:
• Before you are given your injection , the study doctor or nurse will take your
temperature , measure your heigh t and weight, do a physical exam and ask you some
questions about your health.
• The study doctor or nurse will take a blood sample from your arm using a needle (this
will be either 20mL or 10 mL depending on your age group ) and take a sample from
your nose using a swab (like a Q -tip).
• You will then be given an injection into the muscle at the top of your arm.
• If you are part of the selected group of participants, y ou or your parent(s)/ guardian (s)
will be asked to complete an electronic diary about how you are feeling for 7 days after
the visit.
090177e1952b5e4a\Approved\Approved On: 07-Oct-2020 22:21 (GMT)
Page 29
FDA-CBER-2021-5683-0024522
CT05 -GSOP -
SD-GL11 1.0 PHASE 1/2/3 CLINICAL STUDY ASSENT
TEMPLATE FOR OLDER CHILDREN 30-Apr-2020
Protocol Number: C4591001 Assent Version Date : Phase 2/3, 07Oct2020
Study
Country
Site Language: English Center ID: Not Applicable
Country: Not Applicable
Assent Derived From: Older Children Assent, Phase 2/3, 09Sep2020
CT05 -GSOP -SD-GL11 Phase 1/2/3/4 Clinical Study Assent Template for Older Children 30 -Apr-2020
TMF Doc ID : 173.16 (Study); 173.1 0 (Country/Central); 173.20 (Site)
Sponsor Assent Version Number (Study/C ountry/Site) : Phase 2/3 , 07October 2020
Protocol No. C4591001 CONFIDENTIAL Page 4
of 9
At your second visit:
• You will be given your second injection , the study doctor or nurse will take your
temperature and ask you some questions about your health before they give your
inject ion in your arm.
• If you are part of the selected group of participants, y ou or your parent(s)/ guardian (s)
will be asked to comp lete an electronic diary about how you are feeling for 7 days after
the visit.
It is very important that you or your parent(s)/ guardian(s) , as appropriate, complete the
e-Diary regularly as instructed. If this was not completed , your study doctor or nurse will
contact you or your parent(s)/ guardian(s) to check how you are doing.
At the other 4 visits the study doctor or nurse will ask you some questions about your health
and will take a blood sample from your arm using a needle. Each blood sample will be either
about 2 0mL (4 teaspoons) or 10 mL (2 teaspoons) depending on your age group.
When you visit the study doctor, the study doctor will write down information about you. Only
people who are working on this study will see your informatio n. They are required to keep
your information private.
090177e1952b5e4a\Approved\Approved On: 07-Oct-2020 22:21 (GMT)
Page 30
FDA-CBER-2021-5683-0024523
CT05 -GSOP -
SD-GL11 1.0 PHASE 1/2/3 CLINICAL STUDY ASSENT
TEMPLATE FOR OLDER CHILDREN 30-Apr-2020
Protocol Number: C4591001 Assent Version Date : Phase 2/3, 07Oct2020
Study
Country
Site Language: English Center ID: Not Applicable
Country: Not Applicable
Assent Derived From: Older Children Assent, Phase 2/3, 09Sep2020
CT05 -GSOP -SD-GL11 Phase 1/2/3/4 Clinical Study Assent Template for Older Children 30 -Apr-2020
TMF Doc ID: 173.16 (Study); 173.10 (Country/Central); 173.20 (Site)
Sponsor Assent Version Number (Study/C ountry/Site) : Phase 2/3 , 07October 2020
Proto col No. C4591001 CONFIDENTIAL Page 5
of 9
What are the Study Injections ?
There are 2 types of injections in the study. The active study injection and a dummy placebo
injection. A dummy placebo is a pretend vaccine that looks just like the test vaccine but has
no active ingredients in it.
Once the study doctor has checked that it is OK for you to be in the study a computer will
decide if you will get the active study injection or the dummy placebo. You and your
parent(s)/guardian(s) will not be told which injection you will get.
For every 1 child/ young person who receive s the study vaccine, 1 child/ young person will
receive the placebo. No one (including you, your parents, your personal doctor or the study
team) can choose which injection you will get .
WHAT ARE THE POSSIBLE BENEFITS TO ME IF I AGREE TO BE IN THIS
STUDY?
It is not known yet whether the study vaccines may reduce the chance of getting COVID -19,
so you may not directly benefit from taking part in the study. For this reason, you should still
follow local recommendations about how to avoid COVID -19. Information learned from the
research study may help other people in the future .
WHAT ARE THE POSSIBLE UNCOMFORTABLE OR HARMFUL THINGS
THAT COULD HAPPEN TO ME IF I AGREE TO BE IN THIS STUDY?
There is a chance that during the study you could feel pain or feel bad or uncomfortable.
Please let the study doctor know if you experience any of these things. The study team will
monitor you for risks or discomforts during the study. However, the study team does not
know all the effects that the vaccine, or your participation in this study, may have on you.
The injection could cause pain, tiredness, increased body temperature (fever), chills,
headache, and muscle aches .
Other side effects could include redness, swelling and itching; loss of appetite, joint aches
and sweating .
090177e1952b5e4a\Approved\Approved On: 07-Oct-2020 22:21 (GMT)
Page 31
FDA-CBER-2021-5683-0024524
CT05 -GSOP -
SD-GL11 1.0 PHASE 1/2/3 CLINICAL STUDY ASSENT
TEMPLATE FOR OLDER CHILDREN 30-Apr-2020
Protocol Number: C4591001 Assent Version Date : Phase 2/3, 07Oct2020
Study
Country
Site Language: English Center ID: Not Applicable
Country: Not Applicable
Assent Derived From: Older Children Assent, Phase 2/3, 09Sep2020
CT05 -GSOP -SD-GL11 Phase 1/2/3/4 Clinical Study Assent Template for Older Children 30 -Apr-2020
TMF Doc ID: 173.16 (Study); 173.10 (Country/Central); 173.20 (Site)
Sponsor Assent Version Number (Study/Coun try/Site) : Phase 2/3 , 07October 2020
Protoc ol No. C4591001 CONFIDENTIAL Page 6
of 9
You could have an allergic reaction, which means you may have trouble breathing or swelling
of the face or lips. Other allergic reactions may include rash es and very rarely children may
have a nervous system reaction ( for example, a seizure) after a vaccine.
In addition,
• Taking a blood sample may:
o hurt when the needle goes into your arm.
o cause a red spot or bruise on your arm or your arm might feel sore.
o make you feel dizzy.
o cause an infection at the place where th e needle went into your arm.
• Taking a swab from your nose may:
o hurt when the sample i s taken.
o Cause your nose to bleed .
• You may feel embarrassed by the questions the study doctor or nurse asks you.
You might also feel other things. Remember to tell your parent(s) or your guardian(s) and the
study doctor everything you are feeling while you are in the study including if you feel unwell .
Pregnancy, Contraceptives and Babies (do I need to use birth control?)
If you are a girl :
If you are pregnant, planning to become pregnant or breast feeding a baby, you cannot be in
the study.
If you think you are pregnant during the study, you must tell the study doctor immediately.
The study doctor may as k for information about the pregnancy and the birth of the baby. The
study doctor may share this information with others who are working on this study.
If you have started to have periods, the study doctor or nurse will test your urine to make sure
you a re not pregnant before you are given your injections . The doctor or nurse will tell you if
the test results show you are pregnant. Depending on the laws of your area, the study doctor
090177e1952b5e4a\Approved\Approved On: 07-Oct-2020 22:21 (GMT)
Page 32
FDA-CBER-2021-5683-0024525
CT05 -GSOP -
SD-GL11 1.0 PHASE 1/2/3 CLINICAL STUDY ASSENT
TEMPLATE FOR OLDER CHILDREN 30-Apr-2020
Protocol Number: C4591001 Assent Version Date : Phase 2/3, 07Oct2020
Study
Country
Site Language: English Center ID: Not Applicable
Country: Not Applicable
Assent Derived From: Older Children Assent, Phase 2/3, 09Sep2020
CT05 -GSOP -SD-GL11 Phase 1/2/3/4 Clinical Study Assent Template for Older Children 30 -Apr-2020
TMF Doc ID: 173.16 (Study); 173.10 (Country/Central); 173.20 (Site)
Sponsor Assent Version Number (Study/Country/Site) : Phase 2/3 , 07October 2020
Protocol No. C4591001 CONFIDENTIAL Page 7
of 9
or nu rse may also tell your parent(s) or your guardian(s) about the results o f the pregnancy
test.
If you are sexually active, you must use birth control consistently and correctly during the
study and for at least 28 days after your second injection . Your study docto r or nurse will
discuss this wit h you if it is appropriate to do so.
If you are a boy :
If you are sexually active, you must use birth control (eg a condom) consistently and correctly
durin g the study and for at least 28 days after your second injection. Your study doctor or
nurse will di scuss this with you if it is appropriate to do so.
If you think that you may have gotten a girl pregnant, you must tell your study doctor
imme diately. The study doctor may ask for information about the pregnancy and the birth of
the b aby. The study doctor may share this information with others who are working on this
study.
WHA T OTHER OPTIONS ARE THERE?
This study is for research purposes only. Your alternative i s to not take part in this study.
Taking part is voluntary and you do not have to be in the study if you don’t want to.
It is your choice if you want to be in this study or not. No one will be mad if you choose not to
take part.
Your doctors or your parent(s) or your guardian(s) cannot make you be in th e study if you
don't want to be in it. If you say okay now to being in the study and you cha nge your mind
about it later, you can stop being in the study. Just tell the study doctor or your paren t(s) or
your guardian(s) if you want to stop at any time . If you quit the study, you will be asked to
come in for one last visit.
090177e1952b5e4a\Approved\Approved On: 07-Oct-2020 22:21 (GMT)
Page 33
FDA-CBER-2021-5683-0024526
CT05 -GSOP -
SD-GL11 1.0 PHASE 1/2/3 CLINICAL STUDY ASSENT
TEMPLATE FOR OLDER CHILDREN 30-Apr-2020
Protocol Number: C4591001 Assent Version Date : Phase 2/3, 07Oct2020
Study
Country
Site Language: English Center ID: Not Applicable
Country: Not Applicable
Assent Derived From: Older Children Assent, Phase 2/3, 09Sep2020
CT05 -GSOP -SD-GL11 Phase 1/2/3/4 Clinical Study Assent Template for Older Children 30 -Apr-2020
TMF Doc ID: 173.16 (Study); 173.10 (Cou ntry/Central); 173.20 (Site)
Sponsor Assent Version Number (Study/Country/ Site) : Phase 2/3 , 07October 2020
Protocol No. C4591001 CONFIDENTIAL Page 8
of 9
WHAT IF I HAVE QUESTIONS?
You can ask questions about the study at any time.
You can call the study doctor any time.
If you want to ask question s about what it means to be in a research study, you or your
parent(s) or your guardian(s) can call [insert IRB /IEC name ] (a group of people who review
the study to protect your rights) at [insert IRB /IEC number ].
For you to be in this study , you and your parent(s) or your guardia n(s) must agree to you
being in it. But it is still up to you if you want to do it.
090177e1952b5e4a\Approved\Approved On: 07-Oct-2020 22:21 (GMT)
Page 34
FDA-CBER-2021-5683-0024527
CT05 -GSOP -
SD-GL11 1.0 PHASE 1/2/3 CLINICAL STUDY ASSENT
TEMPLATE FOR OLDER CHILDREN 30-Apr-2020
Protocol Number: C4591001 Assent Version Date : Phase 2/3, 07Oct2020
Study
Country
Site Language: English Center ID: Not Applicable
Country: Not Applicable
Assent Derived From: Older Children Assent, Phase 2/3, 09Sep2020
CT05 -GSOP -SD-GL11 Phase 1/2/3/4 Clinical Study Assent Template for Older Children 30 -Apr-2020
TMF Doc ID: 173.16 (Study); 173.10 (Country/Central); 173.20 (Site)
Sponsor Assent Version Number (Study/Cou ntry/Site) : Phase 2/3 , 07October 2020
Protocol No. C4591001 CONFIDENTIAL Page 9
of 9
Please check one box below to show whether or not you want to be in this study .
Yes, I want to be in this study .
No, I do not want to be in this study .
______________________________________________________
Printed Name of Child/Young Person
_____________________________ __ _______ _____________ __________
Child/Young Person Signature Date Time
Statement of person conducting assent discussion:
1. I have explained all aspects of the research to the partic ipant to the best of his or her
ability to understand.
2. I have answered all questions of the partic ipant relating to this research.
3. I believe the partic ipant’s decision to enroll or not enroll is voluntary.
4. If the partic ipant decides to enroll, the study doctor and study staff agree to respect the
partic ipant’s physical or emotional dissent at any time during this research when that
dissent pertains to anything being done solely for the purpose of this research.
Printed Name of Person Obtaining Assent: ____________________________
Signature of Person Obtaining Assent: ________ _________ Date: ________ Time: ______
090177e1952b5e4a\Approved\Approved On: 07-Oct-2020 22:21 (GMT)
Page 35
FDA-CBER-2021-5683-0024528
CT05 -GSOP -RF04
7.0 PHASE 1/2/3 CLINICAL STUDY
INFORMED CONSENT TEMPLATE 01-Jul-2019
Protocol Number: C4591001 ICD Version Date : Parent ICD, P hase 2/3,
07Oct2020
Study
Country
Site Language: English Center ID: Not Applicable
Country: Not
Applicable
ICD Derived From: Parent ICD, Phase 2/3 , 09Sep2020
CT05 -GSOP -RF04 7.0 Phase 1/2/3/4 Clinical Study Informed Consent Template (01-Jul-2019)
TMF Doc ID: 173.13 (Study); 173.07 (Country/Central); 173.23 (Site)
Sponsor Consent Version (Study) Parent, Phase 2/3 , 07October2020
Protocol No: C4591001
CONFIDENTIAL Page:
1 of 23
090177e1952b5e4b\Approved\Approved On: 07-Oct-2020 22:19 (GMT)
Page 36
FDA-CBER-2021-5683-0024529
CONSENT TO TAKE PART IN STUDY
CT05 -GSOP -RF04 7.0 Phase 1/2/3/4 Clinical Study Informed Consent Template (01-Jul-2019)
TMF Doc ID: 173.13 (Study); 173.07 (Country/Central); 173.23 (Site)
Sponsor Consent Version (Study) Parent, Phase 2/3 , 07October2020
Protocol No: C4591001
CONFIDENTIAL Page:
2 of 23
Table of Contents
This Table of Contents describes the different sections of this consent document. Be
sure to read through all sections of this consent document before making your decision
about whether or not to participate in this study.
Section Page
1. Key study information and contact information 4
2. Brief summary of this study 5
3. What is the purpose of this study? 6
4. How long will my child participate in this study? 7
5. How many adults and children will take part in this study? 7
6. What will happen during this study? 7
7. Are there any special instructions to follow for this study? 13
8. What are the possible risks and discomforts of this study? 13
9. What are the possible benefits of this study? 16
10. What will happen to my blood and nasal swab samples? 16
11. What other choices do I have if I do not join this study? 16
12. What happens if I am injured during this study? 16
13. What if I join this study and then change my mind? 17
14. What will I have to pay for if I take part in this study? 17
15. Will I be paid for taking part in this study? 17
16. What will happen to my personal information? 18
090177e1952b5e4b\Approved\Approved On: 07-Oct-2020 22:19 (GMT)
Page 37
FDA-CBER-2021-5683-0024530
CONSENT TO TAKE PART IN STUDY
CT05 -GSOP -RF04 7.0 Phase 1/2/3/4 Clinical Study Informed Consent Template (01-Jul-2019)
TMF Doc ID: 173.13 (Study); 173.07 (Country/Central); 173.23 (Site)
Sponsor Consent Version (Study) Parent, Phase 2/3 , 07October2020
Protocol No: C4591001
CONFIDENTIAL Page:
3 of 23
17. Where can I find additional information about this study or the
study results? 18
18. Signatures 19
Privacy Supplement
090177e1952b5e4b\Approved\Approved On: 07-Oct-2020 22:19 (GMT)
Page 38
FDA-CBER-2021-5683-0024531
CONSENT TO TAKE PART IN STUDY
CT05 -GSOP -RF04 7.0 Phase 1/2/3/4 Clinical Study Informed Consent Template (01-Jul-2019)
TMF Doc ID: 173.13 (Study); 173.07 (Country/Central); 173.23 (Site)
Sponsor Consent Version (Study) Parent, Phase 2/3 , 07October2020
Protocol No: C4591001
CONFIDENTIAL Page:
4 of 23
1. Key Study Information and Contact Information
The study team will address any questions, concerns or complaints you or your child
may have before, during and after you r child complete the study. The study team
includes the study doctor, nurses, and others who work with the study doctor.
Phone numbers for the study team are listed below under “Study Site Contact
Information.” You also will be given a card with important emergency contact
information, including a 24 -hour number. Show this card to any doctor, nurse or
other health care provi der if your child seek s emergency care while taking part in this
study. This card includes information about the study that will help them treat you r child .
If you have any general questions about your child’s rights as a study participant, or
would like to obtain information from, offer suggestions to, or speak with someone not
directly involved in the study, you may contact [For the site -level ICD , include as
appropriate: the Institutional Review Board or the Independent Ethics Committee,
patient rights advocate, and/or bioethicist ] listed below.
Name of Study: A PHASE 1/2/3, PLACEBO -CONTROLLED, RANDOMIZED,
OBSERVER -BLIND, DOSE -FINDING STUDY TO EVALUATE THE SAFETY,
TOLERABILITY, IMMUNOGENICITY, AND EFFICAC Y OF SARS -COV -2 RNA
VACCINE CANDIDATES AGAINST COVID -19 IN HEALTHY INDIVIDUALS
[Institution] Study Number:
Sponsor Study Number: C4591001
Name of Company Sponsoring the Study: BioNTech. Pfizer is conducting the study
for BioNTech
Name of Principal Investigator (Study Doctor):
Study Site Contact Information:
Contact Person:
Address:
Phone Number (Normal Business Hours):
Phone Number (Off -Hours or Emergency):
[Complete the following entries for the site -level ICD as appropriate. ]
[Institutional Review Board or Independent Ethics Committee ] Contact
Information:
Contact Person:
Address:
Phone Number:
090177e1952b5e4b\Approved\Approved On: 07-Oct-2020 22:19 (GMT)
Page 39
FDA-CBER-2021-5683-0024532
CONSENT TO TAKE PART IN STUDY
CT05 -GSOP -RF04 7.0 Phase 1/2/3/4 Clinical Study Informed Consent Template (01-Jul-2019)
TMF Doc ID: 173.13 (Study); 173.07 (Country/Central); 173.23 (Site)
Sponsor Consent Version (Study) Parent, Phase 2/3 , 07October2020
Protocol No: C4591001
CONFIDENTIAL Page:
5 of 23
Patient Rights Advocate:
Contact Person:
Address:
Phone Number:
Bioethicist:
Contact Person:
Address:
Phone Number:
2. Brief Summary of this Study
You are being asked to allow your child to take part in a research study that involves
comparing an investigational (study) vaccine against a placebo (injection with no active
ingredient) to see if the vaccine can prevent COVID -19. The vaccine is given by
injection.
Depending on your child’s age, mental status and local laws, the study team may need
to verify your child’s agreement (called “assent”) to take part in this study . Your
child may give assent verbally, or they may be asked to print or sign their name on an
assent document similar to this consent document. They may have a n opportunity to
meet privately with a member of the study team to ask confidential questions. Your child
will also be able to decide not to take part for confidential reasons, which, if they
request, would not be shared with you unless required by local law. Also, if your child
reach es the legally recognized age of majority (adulthood) during the study, they must
separately provide their consent to continue taking part in the study.
You are be ing asked to allow your child to be in this research study because your child
is healthy and over the age of 1 6.
This is a research study involving both Pfizer and B ioNTech . Pfizer and BioNTech are
separate companies who are cooperating to perform this stu dy. Pfizer is responsible for
conducting this study. B ioNTech is the regulatory sponsor of this study. Funding for this
study is provided by BioNTech and Pfizer and [the study doctor/institution] will be paid
to conduct this study.
A new respiratory disease appeared in Wuhan, China in December 2019 and has since
rapidly spread to many other countries around the world. In January 2020, the cause of
this disease was found to be a new Coronavirus ; and the disease it causes was named
COVID -19 (Coronavirus disease 2019). Since then, many companies around the World
have quickly started to look for treatments and ways to prevent COVID -19. There are no
currently licensed (approved for sale) vaccines for COVID -19.
090177e1952b5e4b\Approved\Approved On: 07-Oct-2020 22:19 (GMT)
Page 40
FDA-CBER-2021-5683-0024533
CONSENT TO TAKE PART IN STUDY
CT05 -GSOP -RF04 7.0 Phase 1/2/3/4 Clinical Study Informed Consent Template (01-Jul-2019)
TMF Doc ID: 173.13 (Study); 173.07 (Country/Central); 173.23 (Site)
Sponsor Consent Version (Study) Parent, Phase 2/3 , 07October2020
Protocol No: C4591001
CONFIDENTIAL Page:
6 of 23
Vaccines help your body to produce antibodies to help you to fight off a disease . This
research study involves 2 investigational vaccines to prevent COVID -19, that will be
given to volunteers . The vaccines are given by injection. The vaccines are slightly
different but work in the same way. The study will also test each of these vaccines at
different dose levels (amounts of vaccine).
These vaccines do not contain the whole virus, or the parts of the virus that can make
your child ill, instead the vaccines are made up of part of the virus’s genetic code,
surrounded by fatty particles called lipids. They use a persons cells’ protein making
machinery to produce some, or all , of the spike protein seen on the outside of the virus.
This spike protein, made by your child’s body, may help your child’s body to produce
antibodies to fight against COVID -19. We will check how many antibodies you r child
make s by taking blood samples and testing them .
This study is different from your child’s regular medical care. The purpose of regular
medical care is to improve or otherwise manage your child’s health, but the purpose of
research is to gather information to advance science and medicine and does not
replace your child’s regular medical care. If you r child need s medical care during their
time in the study, you should contact your regular provider and inform the study team,
as described later in this document.
Allowing your child to t aking part in this study is voluntary (your choice). There is no
penalty or change to your or your child’s regular medical care if y ou decide not to allow
your child to participate. You can choose to let your child take part in the study now, and
then chan ge your mind later at any time without losing any benefits or medical care to
which you or your child are entitled. We encourage you to have conversations with your
family, friends , doctors, and study team about this study and whether it is right for your
child. The study team will work with you to answer any questions that you may have
about the study.
You will receive a signed copy of this consent document for your records. Please keep
this consent document for your reference.
3. What is the purpose of this study?
The World Health Organization (WHO) has declared COVID -19 to be a pandemic (a
disease that has spread all over the world and is affecting lots of people) ; finding a
090177e1952b5e4b\Approved\Approved On: 07-Oct-2020 22:19 (GMT)
Page 41
FDA-CBER-2021-5683-0024534
CONSENT TO TAKE PART IN STUDY
CT05 -GSOP -RF04 7.0 Phase 1/2/3/4 Clinical Study Informed Consent Template (01-Jul-2019)
TMF Doc ID: 173.13 (Study); 173.07 (Country/Central); 173.23 (Site)
Sponsor Consent Version (Study) Parent, Phase 2/3 , 07October2020
Protocol No: C4591001
CONFIDENTIAL Page:
7 of 23
vaccine to prevent COVID -19 is an urgent need. To test this investigational vaccine as
quickly as possible, this study has been separated into 2 phase s. In both the phase s we
will try to see if the vaccine works to prevent COVID -19, as well as :
• Phase 1 where we choose which vaccines at which dose levels are safest and
make the most antibodies .
• Phase 2/3 where we look at one vaccine at one dose level in lots of people to
collect even more information about the safety of the vaccines and the amounts
of antibodies they produce .
Your child is being asked to take part in Phase 2/3.
The study will compare the results of the people who receive the study vaccine with
those who receive a placebo (a placebo does not contain any active ingredients). In this
study the placebo will be salt-water, also known as normal saline. Everyone in Phase
2/3 of the study will receive 2 injections of either:
• Study vaccine followed by study vaccine
• Placebo followed by placebo
In Phase 2/3 everyone who receives the study vaccine will receive the same vaccine at
the same dose, that was chosen based on the results from Phase 1.
The study doctor will determine whether you r child is eligible for the study. This study
will require you r child to visit the study doctor to undergo study procedures and to
provide information about their health. You/your child will also be required to contact
the study doctor if your child experience any of the COVID-19 symptoms (explained
later in this document).
4. How long will my child participate in this study?
Your child could be in this study for up to about 26 months and will need to visit the
study site 6 or 7 planned times during the study . Your child will also need to visit the
study site if they experience COVID -19 symptoms and again after they have recovered
from those symptoms approximately in a month’s time .
5. How many adults and children will take part in this study?
Approximately 44,193 volunteers could take part in the 2 phase s of this study.
In Phase 2/3 of the study up to 43,998 volunteers will take part , in which approximately
2000 will be of 12 to 15 years of age and the remaining will be above the age of 16
years .
6. What will happen during this study?
090177e1952b5e4b\Approved\Approved On: 07-Oct-2020 22:19 (GMT)
Page 42
FDA-CBER-2021-5683-0024535
CONSENT TO TAKE PART IN STUDY
CT05 -GSOP -RF04 7.0 Phase 1/2/3/4 Clinical Study Informed Consent Template (01-Jul-2019)
TMF Doc ID: 173.13 (Study); 173.07 (Country/Central); 173.23 (Site)
Sponsor Consent Version (Study) Parent, Phase 2/3 , 07October2020
Protocol No: C4591001
CONFIDENTIAL Page:
8 of 23
Before any study procedures begin, or before you r child begin s preparing for the study,
you will be asked to read and sign this consent document. We may also ask your child
to read and sign a similar document.
After signing this consent document, the study doctor will check if you r child meet s all of
the requirements to take part in this study. If you r child does not meet the requirements,
they will not be able to take part in the study and the study doctor will explain why this is
the case.
Study Vaccine s
Once the study doctor has confirmed you r child meet s the study requirements , you r
child will be randomly assigned (like flipping a coin) to receive the study vaccine or
placebo. For every 1 volunteer who receive s the study vaccine, 1 volunteer will receive
the placebo. No one (including you, your child, your child’s personal doctor or the study
team) can choose th is assignment .
This is a n ‘observer -blind study’ , which means that you , your child and the study doctor
will not know whether you r child will receiv e the study vaccine or placebo . The person
who gives you r child the vaccine will know because the vaccine and placebo do not look
the same . The syringe will be covered with a label so the co ntents are not visible and
the person that gives you r child the vaccine will not be able to talk about it. In case of
urgent need, the study doctor can learn quickly whether you r child received study
vaccine or placebo .
The study vaccine or placebo will b e given to you r child through an injection into the
muscle of the upper arm. All volunteers will receive 2 injections, approximately 3 weeks
apart. On the days you r child receive s the study vaccine or placebo, you will be asked
to wait at the study site for at least 30 minutes for observation .
Overview of Study Procedures and Assessments
The table below lists the tests and procedures or assessments that will be done in this
research study. In addition to the visits listed, the study doctor may ask you r child to
come in for extra visit(s) if necessary, to protect their well-being.
090177e1952b5e4b\Approved\Approved On: 07-Oct-2020 22:19 (GMT)
Page 43
FDA-CBER-2021-5683-0024536
CONSENT TO TAKE PART IN STUDY
CT05 -GSOP -RF04 7.0 Phase 1/2/3/4 Clinical Study Informed Consent Template (01-Jul-2019)
TMF Doc ID: 173.13 (Study); 173.07 (Country/Central); 173.23 (Site)
Sponsor Consent Version (Study) Parent, Phase 2/3 07October2020
Protocol No: C4591001
CONFIDENTIAL Page:
9 of 23
For people taking part in Phase 2/3, the study doctor or nurse will:
Visit Number 1 2 3 4 5 6
Visit Description Study Vaccine
1 Study Vaccine
2 1-Month Visit 6-Month Visit 12-Month Visit 24-Month Visit
Ask about Medical history as well as date of birth,
sex, race and ethnicity X
Ask about medicines you r child is currently taking X X X X X X
Perform clinical assessment X
Record latest CD4 count and viral load (for HIV
positive v olunteers only) X X X X X
Measure body temperature X X
Measure height and weight X
If your child is female and started her periods , she
will be asked to provide a urine sample for a
pregnancy test. X X
Ask about other vaccinations you r child has had X X X X
Check you r child meet s all the study requirements X X
If needed, we will discuss with your child about
appropriate birth control X X X
Collect blood sample to test antibody levelsa ~20 mL/
~10 mL ~20 mL/
~10 mL ~20mL/
~10 mL ~20 mL/
~10 mL ~20 mL/
~10 mL
Take a nasal swab X X
Get the study injection , followed by a 30mins
observations period X X
Give you /your child an e-diary or help you /your
child download one X
Vaccination e -diary completion for 7 days (if yo ur
child is part of a chosen group to report potential
side effects daily for 7 days following vaccination) X X
090177e1952b5e4b\Approved\Approved On: 07-Oct-2020 22:19 (GMT)
Page 44
FDA-CBER-2021-5683-0024537
CONSENT TO TAKE PART IN STUDY
CT05 -GSOP -RF04 7.0 Phase 1/2/3/4 Clinical Study Informed Consent Template (01-Jul-2019)
TMF Doc ID: 173.13 (Study); 173.07 (Country/Central); 173.23 (Site)
Sponsor Consent Version (Study) Parent, Phase 2/3 07October2020
Protocol No: C4591001
CONFIDENTIAL Page:
10 of 23
For people taking part in Phase 2/3, the study doctor or nurse will:
Visit Number 1 2 3 4 5 6
Visit Description Study Vaccine
1 Study Vaccine
2 1-Month Visit 6-Month Visit 12-Month Visit 24-Month Visit
COVID -19 illness e -diary completion X X X X X X
Ask how you r child is feeling generally X X X X X X
Abbreviation s: HIV = human immunodeficiency virus; e-diary = electronic diary.
a. 20 mL is to be collected from participants ≥16 years of age; 10 mL is to be collected from participants 12 to 15 years of age .
090177e1952b5e4b\Approved\Approved On: 07-Oct-2020 22:19 (GMT)
Page 45
FDA-CBER-2021-5683-0024538
CONSENT TO TAKE PART IN STUDY
CT05 -GSOP -RF04 7.0 Phase 1/2/3/4 Clinical Study Informed Consent Template (01-Jul-2019)
TMF Doc ID: 173.13 (Study); 173.07 (Country/Central); 173.23 (Site)
Sponsor Consent Version (Study) Parent, Phase 2/3 , 07October 2020
Protocol No: C4591001
CONFIDENTIAL Page:
11 of 23
Blood samples for antibody testing
Your child will have blood taken 5 times during the planned visits of the study. This will
be used to test if they already had antibodies against the coronavirus that causes
COVID -19 when they enrolled in the study and may be used to test their antibody levels
after vaccination . If you r child is 16 years of age or above , about 20 mL of blood (about
4 teaspoons) will be collected f rom their arm using a needle at these visits. Alternatively,
if your child is between 12 to 15 years of age , about 10 mL of blood (about 2 teaspoons)
will be collected from their arm using a needle at the above specified visits.
E-Diary
At Visit 1, the study team will show you or your child how to fill in an electronic diary (or
e-Diary). Parent(s)/ legal guardian (s), as appropriate, will be required to complete the e -
diary on behalf of y ounger age group children , whilst children in older age group might
not require similar level of support from their parent(s)/ legal guardian (s). Therefore,
older age group children (e.g. 16 years or above ) are expected to complete the e -diary
themselves.
We will either give you/ your child a device (a bit like a mobile phone) or ask to
download an application (‘app’) to smart phone if you or your child has one. The
device/app is secure, and your child’s confidentiality will be maintained.
There are 2 parts to the e -Diary. Everyone will nee d to complete the COVID -19 illness
part of the e -Diary on the device or app on their smartphone. The COVID -19 illness e -
Diary will prompt you/ your child to record any COVID -19 symptoms (see below) every 7
days or at any time you r child has COVID -19 symptoms. You or your child may also
receive text messages to the device or your /your child’s own smartphone, or emails (if
you/they provide your /their email address) to remind you /your child to complete the
COVID -19 illness part of the e -Diary.
If you r child is part of a subset of participants, you/ your child will also be instructed by
the study team to complete the vaccination part of the e-Diary for 7 days after each
vaccination, once a day in the evening with the first day being the day of the
vaccination.
You/ your child will be given a thermometer and a measuring device to take home. You/
your child will use the thermometer to measure temperature under the tongue and will
use the measuring device to measure any redness or swelling where the injection was
given. You/ your child will need to record these measurements in the vaccination part of
the e-Diary.
The vaccination part of the e-Diary will also ask other questions ab out potential side
effects you r child may have after the injection. If you r child has any severe symptoms
090177e1952b5e4b\Approved\Approved On: 07-Oct-2020 22:19 (GMT)
Page 46
FDA-CBER-2021-5683-0024539
CONSENT TO TAKE PART IN STUDY
CT05 -GSOP -RF04 7.0 Phase 1/2/3/4 Clinical Study Informed Consent Template (01-Jul-2019)
TMF Doc ID: 173.13 (Study); 173.07 (Country/Central); 173.23 (Site)
Sponsor Consent Version (Study) Parent, Phase 2/3 , 07October 2020
Protocol No: C4591001
CONFIDENTIAL Page:
12 of 23
after vaccination, you/ your child should contact your study doctor and the study doctor
or nurse may schedule an extra visit.
It is very important that you / your child, as appropriate, complete the e -Diary regularly
as instructed. If this was not completed , your study doctor or nurse will contact you / your
child to check how your child is doing .
Urine pregnancy test
If your child is female and has started her periods, she will be asked to provide a urine
sample to check she is not pregnant before given the study injection .
What happens if my child has positive nasal swab test result?
Nasal swabs obtained during the study (at Visits 1 and 2, and at the time of a potential
COVID -19 illness – see below) will be tested in a research laboratory. P ositive results
from the Visit 1 and 2 swabs, and all results from the illness visit swabs, will be provided
to your study doctor, but this will take some time so you should not rely on these for
your child’s medical treatment . If your child has a positive nasal swab test result for the
coronavirus that causes COVID -19, either at Visit 1 or any time between Visit 1 and
Visit 2, but with no potential COVID -19 related symptoms, they will continue to receive
the second study vaccine as normal. However, if the positive COVID -19 test result is
accompanied by potential COVID -19 related symptoms, they will not be given the
seco nd study vaccine but will be requested to remain in the study.
If You r Child Gets COVID -19 Symptoms
If you r child gets any of the following you must contact the study doctor straight
away . Note that this is not instead of routine medical care. If you r child feels
unwell enough that you would normally see a healthcare professional, please
contact your usual provider , as well as the study doctor .
• A diagnosis of COVID -19;
• Fever;
• New or increased cough;
• New or increased shortness of breath;
• Chills ;
• New or increased muscle pain ;
• New l oss of taste/smell ;
• Sore throat ;
• Diarrhea;
• Vomiting .
090177e1952b5e4b\Approved\Approved On: 07-Oct-2020 22:19 (GMT)
Page 47
FDA-CBER-2021-5683-0024540
CONSENT TO TAKE PART IN STUDY
CT05 -GSOP -RF04 7.0 Phase 1/2/3/4 Clinical Study Informed Consent Template (01-Jul-2019)
TMF Doc ID: 173.13 (Study); 173.07 (Country/Central); 173.23 (Site)
Sponsor Consent Version (Study) Parent, Phase 2/3 , 07October 2020
Protocol No: C4591001
CONFIDENTIAL Page:
13 of 23
The study doctor may ask you /your child to have a telephone conversation , video call or
to visit the site to talk about how they are feeling and if they have needed any other
medical care. The study team will also ask you to help your child to take a nose swab ,
or the study team may take a swab to check for the coronavirus (only once during each
illness) . We will give you /your child separate instructions about how to take a nose swab
and how to ship the swab to the laboratory if needed . The result from this swab will be
provided to the study doctor once it is available, but this will take some time, and cannot
be used to diagnose COVID -19. This is why it is important that you contact your usual
provider if you r child has COVID -19 symptoms and think you r child need s medical care.
If your child is di agnosed with COVID -19, for the purposes of the study, the study doctor
will contact your child’s usual provider , and any facility where you child is treated , to
obtain details and collect medical records : by signing this informed consent document,
you agre e to this .
The study team will arrange an extra visit to the study site about a month after you r child
became unwell and you r child will need to give another 20 mL (about 4 teaspoons) or
10 mL (about 2 teaspoons) of blood sample , as appropriate, to test their antibody levels.
After the study
The study vaccine is available only during this study and not after the study is over.
7. Are there any special instructions to follow for this study?
It is important you and your child follow all the instructions given by the study nurse or
doctor and tell them if:
• You don’t understand anything about the study
• You /your child are not able to comply with the study requirements
• There are changes in your child’s health
• Your child takes any new medications or receive any other vaccines
• You or your child are going away for a long period
• Your child wishes to take part in another research study
8. What are the possible risks and discomforts of this study?
Any research has some risks, which may include negative effects that could make you r
child unwell or uncomfortable and even potentially be serious or life -threatening. All
research participants taking part in the study will be watched carefully for any negative
effects; howeve r, the study team does not know all the effects that the study vaccine
may have on you.
090177e1952b5e4b\Approved\Approved On: 07-Oct-2020 22:19 (GMT)
Page 48
FDA-CBER-2021-5683-0024541
CONSENT TO TAKE PART IN STUDY
CT05 -GSOP -RF04 7.0 Phase 1/2/3/4 Clinical Study Informed Consent Template (01-Jul-2019)
TMF Doc ID: 173.13 (Study); 173.07 (Country/Central); 173.23 (Site)
Sponsor Consent Version (Study) Parent, Phase 2/3 , 07October 2020
Protocol No: C4591001
CONFIDENTIAL Page:
14 of 23
If you r child takes part in this study, the most likely risks or discomforts are discussed
below.
It is important that you report to the study team all symptoms and side effects as
soon as they occur. Phone numbers for the study team are listed in [Section 1 ] of
this consent document.
Study Vaccine Risks
In early studies , these vaccines were administered to approximately 350 people (up
until August 6th, 2020 ). In the ongoing Phase 2/3 part of the study that you are
considering joining your child in, 36,576 people have been enrolled (up until October 5th
2020), approximately half of whom will have received the study vaccine and half of
whom will have received placebo. Based on these studies , the following risks have been
determined to be caused by study vaccine :
Injection site pain, fatigue (tiredness), increased body temperature (fe ver), chills,
headache and muscle aches.
Other risks that commonly occur following vaccines in general include:
Injection site redness, swelling and itching; loss of appetite, joint aches and sweating.
As in all research studies, the COVID -19 vaccines may involve risks that might be
expected based on results from studies of similar vaccines, as well as risks that are
currently unknown.
As with any vaccine given by injection, adults or children may have an allergic reaction.
The allergic reaction could be minor (rashes) or more severe (swelling of the face or lips
and/or shortness of breath). A severe allergic shock (anaphylactic shock) could occur.
Very rarely, adults or children may have a nerv ous system reaction (for example, a
seizure) after a vaccine.
Therefore, it is important that you /your child report all symptoms and side effects that
your child experience as soon as they occur, whether or not you think they are caused
by the study vaccin e.
Due to the way in which the study vaccines are made, they cannot cause COVID -19
disease.
If I catch COVID -19 disease, could the vaccine make it worse?
For some other vaccines tested in animals against similar viruses (but not the
coronavirus that causes COVID -19), there have been reports of the illness being more
severe in the animals that received the vaccine than in those that did not. So far this has
not been seen with COVID -19 vaccines, but at the moment we do not know whether the
study vaccines coul d make a later COVID -19 illness more severe. That is one of the
reasons why you /your child are asked to contact your study doctor if you r child develop s
090177e1952b5e4b\Approved\Approved On: 07-Oct-2020 22:19 (GMT)
Page 49
FDA-CBER-2021-5683-0024542
CONSENT TO TAKE PART IN STUDY
CT05 -GSOP -RF04 7.0 Phase 1/2/3/4 Clinical Study Informed Consent Template (01-Jul-2019)
TMF Doc ID: 173.13 (Study); 173.07 (Country/Central); 173.23 (Site)
Sponsor Consent Version (Study) Parent, Phase 2/3 , 07October 2020
Protocol No: C4591001
CONFIDENTIAL Page:
15 of 23
symptoms that might be caused by COVID -19 (for example, fever, cough, shortness of
breath).
Placebo Risks
As the placebo injection contain s salt -water and no active ingredients, the chances of
having the side effects mentioned above are less likely. In other studies, using the same
placebo , some volunteers who received the placebo injection repor ted pain, bruising,
swelling and redness at the site of injection.
Risks from Study Procedures
Risks and possible discomforts from the study procedures include:
• Blood samples: The risks and possible discomforts involved in taking blood
include pain from inserting the needle, or less often, swelling, bruising, or
infection around the vein where the blood is collected. You r child may feel dizzy
or may faint. If you r child has a previous history of feeling dizzy or fainting during
blood sample collecti on, you should talk to the study doctor.
• Nasal S wabs : The risks and possible discomforts invo lved in takin g nasal swabs
may include pain or general discomfort. Sometimes it may cause the nose to
bleed.
Pregnancy -Related Risks; Use of Birth Control
If your child is currently pregnant, plans to become pregnant, or is breastfeeding a child,
they should not join this study.
If you r child is able to have children and is sexually active, they must use birth control
consistently and correctly for at least 28 days after they receive their last injection . This
applies to males as well as females who take part in the research study. The study
doctor will discuss with you r child the methods of birth control that they should use while
in this research study . The study doctor will help you child select the method that is
appropriate for them . The study doctor will also check that you r child understand s how
to use the birth control method and may review this with them at each of their research
study visits.
Birth control methods, even when used properly are not perfect. If you r child or their
partner becomes pregnant during the research study, or if they want to stop their
required birth control during the research study, they should te ll the study doctor
immediately . You r child may b e withdrawn from the research study if they stop using
birth control or they become pregnant.
090177e1952b5e4b\Approved\Approved On: 07-Oct-2020 22:19 (GMT)
Page 50
FDA-CBER-2021-5683-0024543
CONSENT TO TAKE PART IN STUDY
CT05 -GSOP -RF04 7.0 Phase 1/2/3/4 Clinical Study Informed Consent Template (01-Jul-2019)
TMF Doc ID: 173.13 (Study); 173.07 (Country/Central); 173.23 (Site)
Sponsor Consent Version (Study) Parent, Phase 2/3 , 07October 2020
Protocol No: C4591001
CONFIDENTIAL Page:
16 of 23
Pregnancy Follow -up
If you r child or their your partner become pregnant during the study, up until 6 months
after their last study injection , please tell the study doctor immediately . Please also tell
the doctor who will be taking care of your child/their partner during the pregnancy that
your child took part in this study. The study doctor will ask if you r child /their partner or
their pregnancy doctor is willing to provide updates on the progress of the pregnancy
and its outcome. If you r child /their partner agree, this information will be provided to
BioNTech/ Pfizer for safety follow -up.
9. What are possible benefits of this study?
It is not known yet whether the study vaccines may reduce the chance of getting
COVID -19, so you r child may not directly benefit from participating in the study. For this
reason, you still need to let your child follow local recommendations about how to avoid
COVID -19. Information learned from the research study may help other people in the
future .
10. What will happen to my child’s blood and nasal swab
samples?
Your child’s blood and nasal swab samples will be used only for scientific research.
Each sample will be labeled with a code so that the laboratory workers testing the
samples will not know who your child is. Some of the samples may be stored for future
testing and may be kept for up to 15 years after the study ends, at which time they will
be destroyed. In addition to testing for this study, any samples left over after the study
is complete may be used for additional research related to the development of products.
No testing of your child’s DNA will be performed.
You may request that your child’s samples, if they can be identified, be destroyed at any
time. Any data already collected from those samples wil l still be used for the study. The
samples will remain the property of BioNTech/ Pfizer and may be shared with other
researchers as long as confidentiality is maintained, and no testing of your child’s DNA
will be performed. You and your child will not be t old of additional tests, nor will you or
your child receive results of any of these tests.
11. What other choices do I have if I do not my child to join this
study?
This study is for research purposes only. The only alternative is to not take part in this
study .
12. What happens if my child is injured during this study?
090177e1952b5e4b\Approved\Approved On: 07-Oct-2020 22:19 (GMT)
Page 51
FDA-CBER-2021-5683-0024544
CONSENT TO TAKE PART IN STUDY
CT05 -GSOP -RF04 7.0 Phase 1/2/3/4 Clinical Study Informed Consent Template (01-Jul-2019)
TMF Doc ID: 173.13 (Study); 173.07 (Country/Central); 173.23 (Site)
Sponsor Consent Version (Study) Parent, Phase 2/3 , 07October 2020
Protocol No: C4591001
CONFIDENTIAL Page:
17 of 23
For mandatory research injury language, < click here > (retain this link in the study -level
ICD). The country -specific research injury language must be included verbatim in the
country -level ICD .
13. Can I withdraw my child from the study?
Yes. You are free to withdraw your consent for your child and discontinue their
participation in the research study at any time . Your decision will not affect your or your
child’s regular medical care or any benefits to which you /your child is are entitled. Tell
the study doctor if you are thinking about stopping or decide to stop so that you r child
can end participation in the study in the safest way.
While you r child is participating , the study team will tell you in a timely manner if new
information is learned during the course of the st udy that could change your mind about
your child continuing in this study. If you decide to withdraw your child from the study,
your child may be asked to continue to participate in the study procedures even though
they would no longer receive the study vaccine.
If your child continue s with the study, information about their health will continue to be
collected as described in [Section 6].
If you decide to stop your child participating in this study, you must notify the study
doctor. The study team will explain what other procedures or discussions would occur.
Sometimes the study doctor or BioNTech/ Pfizer may decide to take you r child out of the
study (even if you do not agree ) if:
• You/your child are unable or unwilling to follow the instructions of the study team;
• The study doctor decides that the study is not in your child’s best interest or that they
are no longer eligible to participate; or
• The study is stopped by BioNTech/Pfizer , the institutional review board (IRB) or
independent ethics committee (IEC) (a group of people who review the study to
protect your rights), or by a government or regulatory agency .
The study team will give you a Privacy Supplement, which is considered par t of this
consent document. It describes what happens to your child’s personal information
(including biological samples) and how it may be used if you withdraw your child from
the study.
14. What will I have to pay for if my child takes part in this study?
You will not need to pay for any of the study vaccines (COVID -19 Vaccine or placebo),
study -related procedures, or study visits.
15. Will my child be paid for taking part in this study?
090177e1952b5e4b\Approved\Approved On: 07-Oct-2020 22:19 (GMT)
Page 52
FDA-CBER-2021-5683-0024545
CONSENT TO TAKE PART IN STUDY
CT05 -GSOP -RF04 7.0 Phase 1/2/3/4 Clinical Study Informed Consent Template (01-Jul-2019)
TMF Doc ID: 173.13 (Study); 173.07 (Country/Central); 173.23 (Site)
Sponsor Consent Version (Study) Parent, Phase 2/3 , 07October 2020
Protocol No: C4591001
CONFIDENTIAL Page:
18 of 23
You will not receive any payment for your child taking part in this study. However, for
each visit you /your child complete s, you will be reimbursed by the study site to cover
reasonable expenses (for example, parking, meals, travel) that you have as a result of
taking part in this study. You will be reimbursed by [enter, as applicable, method of
reimbursement; amounts; and reimbursement schedule; note whether receipts are
required].
BioNTech/Pfizer may use information resulting from the study to develop products or
processes from which they may make a profit. There are no plans to pay you /your child
or provide you /your child with any products developed from this research.
BioNTech/Pfizer will own all products or processes that are developed using information
from the study.
16. What will happen to my personal information?
<click here > for language to be inserted into this section. This text must be inserted
verbatim. Any requeste d changes must be approved by Clinical Development Legal. Note
that the Privacy Supplement follows this consent document, after the signature section.
17. Where can I find additional information about this study or the
study results?
A description of this clinical trial will be available on http://www.ClinicalTrials.gov , as
required by U.S. Law. This Web site will not include information that can identify you r
child. At most, the Web site will include a summary of the results. You can search this
Web site at any time.
The study results, when available, may also be found on www.pfizer.com and
https://www.clinicaltrialsregister.eu/ .
In addition, a plain summary of the study results will be made available in the EU database
at [insert link to the database ]. This information will be provided no matter what the study’s
outcome. To the extent possible, you will be able to access these summaries in the EU
database soon after they become available using the following EU trial number for the
study: [insert trial number ].
These Web sites are in English only. If you need assistance understanding these Web
sites, please ask a member of the study team.
BioNTech/Pfizer will provide the study doctor with information about the study results
when all participants have completed the study. At that time, certain of your child’s
individual study results may be given to you or your child’s doctor (if different from the
study doctor) in accordance with applicable law , but will not be given to your family, your
employer or any insurance company .
090177e1952b5e4b\Approved\Approved On: 07-Oct-2020 22:19 (GMT)
Page 53
FDA-CBER-2021-5683-0024546
CONSENT TO TAKE PART IN STUDY
CT05 -GSOP -RF04 7.0 Phase 1/2/3/4 Clinical Study Informed Consent Template (01-Jul-2019)
TMF Doc ID: 173.13 (Study); 173.07 (Country/Central); 173.23 (Site)
Sponsor Consent Version (Study) Parent, Phase 2/3 , 07October 2020
Protocol No: C4591001
CONFIDENTIAL Page:
19 of 23
If any exploratory research is done, it may not be possible to link any results from that
exploratory research to specific individuals, including your child . BioNTech/Pfizer does
not plan to return information from any exploratory research to you /your child , the study
doctor, or your doctor (if different from the study doctor).
18. Signatures
Agreement to Participate and to Process Data
1. I confirm I have read (or, if I cannot read, a study team member has read to me)
and understand this consent document for the study described above and have
had the opportunity to ask questions. I have had enough time to review this
consent document. I also have had an opportunity to ask about the details of the
study and to decide whether or not to participate.
2. I have read and understand the Privacy Supplement. I understand that taking part
in the study will require the processing (including colle ction, use, transfer, storage,
analysis and reporting) of my child’s personal information, as explained in the
Privacy Supplement. I understand and agree to the processing of my child’s
personal information within and outside my country of residence for he alth care,
medical research and/or regulatory purposes.
3. I understand that taking part is voluntary and that I am free to stop my child taking
part in this study or to withdraw my consent to the processing of my child’s
personal information at any tim e. I do not need to give any reason and my child’s
regular medical care and legal rights will not be affected. However, even if I
withdraw my consent to processing, my child’s personal information held at that
time may be kept to comply with laws and regul ations and to maintain the integrity
of the study. I also understand that my child’s biological samples may not be able
to be destroyed because they may no longer be traceable to my child , may have
already been used, or may have been given to a third part y.
4. I agree to the study team accessing my child’s medical history, including
information from medical records and test results and any medical treatment my
child receive during the course of the study, and if necessary, contacting my
child’s doctor or any other health care providers treating my child for access to
such information.
5. I understand that BioNTech/Pfizer and/or others working with or on behalf of
BioNTech/Pfizer , institutional review boards (IRBs) or independent ethics
committees (IECs) , and regulatory agencies may need access to personal
090177e1952b5e4b\Approved\Approved On: 07-Oct-2020 22:19 (GMT)
Page 54
FDA-CBER-2021-5683-0024547
CONSENT TO TAKE PART IN STUDY
CT05 -GSOP -RF04 7.0 Phase 1/2/3/4 Clinical Study Informed Consent Template (01-Jul-2019)
TMF Doc ID: 173.13 (Study); 173.07 (Country/Central); 173.23 (Site)
Sponsor Consent Version (Study) Parent, Phase 2/3 , 07October 2020
Protocol No: C4591001
CONFIDENTIAL Page:
20 of 23
information about my child generated at the study site or collected by the study
team for the study and any other research. I agree that they may have access to
my child’s personal info rmation.
6. I do not give up any of my child’s legal rights by signing this consent document. I
have been told that I will receive a signed and dated copy of this document.
7. I agree for my child to take part in the study described in this document.
In the section below, the term “legally acceptable representative” should be replaced with the
term required per local regulation (country -level).
As the consenting adult providing permission for this child to participate in the study, I
acknowledge th at (Please check one of the following):
□ I am the biological or adoptive parent of the child.
□ I am the legal guardian or legally acceptable representative of the child.
[If neither option below is checked, then the consent of the second parent/guardian/legally
acceptable representative must be obtained. If there are two parents/guardians/legally acceptable
representatives available to give permission, and they disagree about allowing the child to
participate in the study, the child should not be enrolled unless that disagreement can be
resolved. ]
I also acknowledge that ( Please check one of the following):
□ I have sole legal responsibility for the care and custody of the child.
□ The other adult(s) with whom I share legal responsibility for the care and custody of the
child (for example, biological parent, adoptive parent, or legal guardian or representative)
is (1) aware of and agrees with my granting permission for this child to participate in the
study OR (2) deceased, unknown, incompetent, or not reasonably available (someone is
“not reasonably available” when he/she cannot be reached by phone/mail/email because,
for example, he/she is on active military duty or is incarcerated) .
_____________________________________
Printed name of parent/guardian/legally acceptable representative
________________________________________________ ______________
Signature of parent/guardian/legally acceptable representative Date of signature§
090177e1952b5e4b\Approved\Approved On: 07-Oct-2020 22:19 (GMT)
Page 55
FDA-CBER-2021-5683-0024548
CONSENT TO TAKE PART IN STUDY
CT05 -GSOP -RF04 7.0 Phase 1/2/3/4 Clinical Study Informed Consent Template (01-Jul-2019)
TMF Doc ID: 173.13 (Study); 173.07 (Country/Central); 173.23 (Site)
Sponsor Consent Version (Study) Parent, Phase 2/3 , 07October 2020
Protocol No: C4591001
CONFIDENTIAL Page:
21 of 23
[Include the statements and signature lines below for a second parent/guardian/legally
acceptable representative if (1) required by the IRB/IEC; (2) required by local law ( e.g.,
parents are divorced and have shared custody of the child); or (3) the second
parent/guardian/legally acceptable representative is (or would like to be) involved in
the consent process and there is reason to believe that he/she may disagree with the
decision of the first parent/guardian/legally acceptable represen tative.
Consent of Second Parent/Guardian/Legally Acceptable Representative:
As the consenting adult providing permission for this child to participate in the study, I
acknowledge that ( Please check one of the following):
□ I am the biological or adoptive parent of the child.
□ I am the legal guardian or legally acceptable representative of the child.
_______________________________________________
Printed name of parent/guardian/legally acceptable representative
________________________________________________ ______________
Signature of parent/guardian/legally acceptable representative Date of signature§]
Person Obtaining Consent:
_____________________________________________
Printed name of person conducting the consent discussion
_____________________________________________ ______________
Signature of person conducting the consent discussion† Date of si gnature
§ Participant /parent /guardian/legally acceptable representative must personally date their
respective signature s.
090177e1952b5e4b\Approved\Approved On: 07-Oct-2020 22:19 (GMT)
Page 56
FDA-CBER-2021-5683-0024549
CONSENT TO TAKE PART IN STUDY
CT05 -GSOP -RF04 7.0 Phase 1/2/3/4 Clinical Study Informed Consent Template (01-Jul-2019)
TMF Doc ID: 173.13 (Study); 173.07 (Country/Central); 173.23 (Site)
Sponsor Consent Version (Study) Parent, Phase 2/3 , 07October 2020
Protocol No: C4591001
CONFIDENTIAL Page:
22 of 23
† The investigator, or an appropriately qualified and trained person designated by the investigator
to conduct the informed consent process, must sign and date the consent document during the
same discussion when the participant’s parent/guardian/legally acc eptable representative signs
the consent document .
090177e1952b5e4b\Approved\Approved On: 07-Oct-2020 22:19 (GMT)
Page 57
FDA-CBER-2021-5683-0024550
PRIVACY SUPPLEMENT
CT05 -GSOP -RF04 7.0 Phase 1/2/3/4 Clinical Study Informed Consent Template (01-Jul-2019)
TMF Doc ID: 173.13 (Study); 173.07 (Country/Central); 173.23 (Site)
Sponsor Consent Version (Study) Parent, Phase 2/3 , 07October 2020
Protocol No: C4591001
CONFIDENTIAL Page:
23 of 23
PRIVACY SUPPLEMENT
For mandatory country -specific data privacy language to be inserted in this Privacy
Supplement, <click here > (retain this link in the study -level ICD). The country -specific
data privacy language must be included verbatim in the country -level ICD. Any requested
changes must be approved by Clinical Development Legal.
Who will use my child’s personal information, how will they use it, and where will
it be stored?
[Mandatory study language – retain the below paragraph and delete this green text before
finalis ation ]
Any personal information collected about you /your child during this study will be entered
into records, including health records, maintained by the study team at your study site.
You/your child’s records that include information that directly identifies you/your child may
be uploaded to secure systems maintain ed by a third party engaged by BioNTech/ Pfizer
so that BioNTech/ Pfizer and/or BioNTech/ Pfizer representatives can review and verify
study data. Some of the uploaded records will be kept for XX years. The remaining
records that are uploaded will be tempor ary and removed from the secure system after
the study is over.
090177e1952b5e4b\Approved\Approved On: 07-Oct-2020 22:19 (GMT)
Page 58
FDA-CBER-2021-5683-0024551
CT05 -GSOP -RF04
7.0 PHASE 1/2/3 CLINICAL STUDY
INFORMED CONSENT TEMPLATE 01-Jul-2019
Protocol Number: C4591001 ICD Version Date : Phase 2/3, 07Oct 2020
Study
Country
Site Language: English Center ID: Not Applicable
Country:
ICD Derived From: Study level, Phase 2/3, 09Sep2020
CT05 -GSOP -RF04 7.0 Phase 1/2/3/4 Clinical Study Informed Consent Template (01-Jul-2019)
TMF Doc ID: 173.13 (Study); 173.07 (Country/Central); 173.23 (Site)
Sponsor Consent Version (Study) Phase 2/3, 07October2020
Protocol No: C4591001
CONFIDENTIAL Page:
1 of 20
090177e1952b5e4c\Approved\Approved On: 07-Oct-2020 22:21 (GMT)
Page 59
FDA-CBER-2021-5683-0024552
CONSENT TO TAKE PART IN STUDY
CT05 -GSOP -RF04 7.0 Phase 1/2/3/4 Clinical Study Informed Consent Template (01-Jul-2019)
TMF Doc ID: 173.13 (Study); 173.07 (Country/Central); 173.23 (Site)
Sponsor Consent Version (Study) Phase 2/3, 07October2020
Protocol No: C4591001
CONFIDENTIAL Page:
2 of 20
Table of Contents
This Table of Contents describes the different sections of this consent document. Be
sure to read through all sections of this consent document before making your decision
about whether or not to participate in this study.
Section Page
1. Key study information and contact information 4
2. Brief summary of this study 5
3. What is the purpose of this study? 6
4. How long will I participate in this study? 7
5. How many people will take part in this study? 7
6. What will happen during this study? 7
7. Are there any special instructions to follow for this study? 12
8. What are the possible risks and discomforts of this study? 12
9. What are the possible benefits of this study? 14
10. What will happen to my blood and nasal swab samples? 15
11. What other choices do I have if I do not join this study? 15
12. What happens if I am injured during this study? 15
13. What if I join this study and then change my mind? 15
14. What will I have to pay for if I take part in this study? 16
15. Will I be paid for taking part in this study? 16
16. What will happen to my personal information? 16
090177e1952b5e4c\Approved\Approved On: 07-Oct-2020 22:21 (GMT)
Page 60
FDA-CBER-2021-5683-0024553
CONSENT TO TAKE PART IN STUDY
CT05 -GSOP -RF04 7.0 Phase 1/2/3/4 Clinical Study Informed Consent Template (01-Jul-2019)
TMF Doc ID: 173.13 (Study); 173.07 (Country/Central); 173.23 (Site)
Sponsor Consent Version (Study) Phase 2/3, 07October2020
Protocol No: C4591001
CONFIDENTIAL Page:
3 of 20
17. Where can I find additional information about this study or the
study results? 17
18. Signatures 17
Privacy Supplement
090177e1952b5e4c\Approved\Approved On: 07-Oct-2020 22:21 (GMT)
Page 61
FDA-CBER-2021-5683-0024554
CONSENT TO TAKE PART IN STUDY
CT05 -GSOP -RF04 7.0 Phase 1/2/3/4 Clinical Study Informed Consent Template (01-Jul-2019)
TMF Doc ID: 173.13 (Study); 173.07 (Country/Central); 173.23 (Site)
Sponsor Consent Version (Study) Phase 2/3, 07October2020
Protocol No: C4591001
CONFIDENTIAL Page:
4 of 20
1. Key Study Information and Contact Information
The study team will address any questions, concerns or complaints you may have
before, during and after you complete the study. The study team includes the study
doctor, nurses, and others who work with the study doctor.
Phone numbers for the study team are listed below under “Study Site Contact
Information.” You also will be given a card with important emergency contact
information, including a 24 -hour number. Show this card to any doctor, nurse or
other health care provi der if you seek emergency care while you are taking part in this
study. This card includes information about the study that will help them treat you.
If you have any general questions about your rights as a study participant, or would like
to obtain inform ation from, offer suggestions to, or speak with someone not directly
involved in the study, you may contact [For the site -level ICD , include as appropriate:
the Institutional Review Board or the Independent Ethics Committee, patient rights
advocate, and/or bioethicist ] listed below.
Name of Study: A PHASE 1/2/3, PLACEBO -CONTROLLED, RANDOMIZED,
OBSERVER -BLIND, DOSE -FINDING STUDY TO EVALUATE THE SAFETY,
TOLERABILITY, IMMUNOGENICITY, AND EFFICACY OF SARS -COV -2 RNA
VACCINE CANDIDATES AGAINST COVID -19 IN HEALTHY INDIVIDUALS
[Institution] Study Number:
Sponsor Study Number: C4591001
Name of Company Sponsoring the Study: BioNTech. Pfizer is conducting the study
for BioNTech
Name of Principal Investigator (Study Doctor):
Study Site Contact Information:
Contact Person:
Address:
Phone Number (Normal Business Hours):
Phone Number (Off -Hours or Emergency):
[Complete the following entries for the site -level ICD as appropriate. ]
[Institutional Review Board or Independent Ethics Committee ] Contact
Information:
Contact Person:
Address:
Phone Number:
090177e1952b5e4c\Approved\Approved On: 07-Oct-2020 22:21 (GMT)
Page 62
FDA-CBER-2021-5683-0024555
CONSENT TO TAKE PART IN STUDY
CT05 -GSOP -RF04 7.0 Phase 1/2/3/4 Clinical Study Informed Consent Template (01-Jul-2019)
TMF Doc ID: 173.13 (Study); 173.07 (Country/Central); 173.23 (Site)
Sponsor Consent Version (Study) Phase 2/3, 07October2020
Protocol No: C4591001
CONFIDENTIAL Page:
5 of 20
Patient Rights Advocate:
Contact Person:
Address:
Phone Number:
Bioethicist:
Contact Person:
Address:
Phone Number:
2. Brief Summary of this Study
This is a research study involving both Pfizer and B ioNTech . Pfizer and BioNTech are
separate companies who are cooperating to perform this study. Pfizer is responsible for
conducting this study. B ioNTech is the regulatory sponsor of this study. Funding for this
study is provided by BioNTech and Pfizer and [the study doctor/institution] will be paid
to conduct this study.
A new respiratory disease appeared in Wuhan, China in December 2019 and has since
rapidly spread to many other countries around the world. In January 2020, the cause of
this disease was found to be a new Coronavirus ; and the disease it causes was named
COVID -19 (Coronavirus disease 2019). Since then, many companies around the World
have quickly started to look for treatments and ways to prevent COVID -19. There are no
currently licensed (approved for sale) vaccines for COVID -19.
Vaccines help your body to produce antibodies to help you to fight off a disease . This
research study involves 2 investigational vaccines to prevent COVID -19, that will be
given to healthy volunteers . The vaccines are given by injection. The vac cines are
slightly different but work in the same way. The study will also test each of these
vaccines at different dose levels (amounts of vaccine).
These vaccines do not contain the whole virus, or the parts of the virus that can make
you ill, instead the vaccines are made up of part of the virus’s genetic code, surrounded
by fatty particles called lipids. They use your own cells’ protein making machinery to
produce some, or all , of the spike protein seen on the outside of the virus. This spike
protein, made by your own body, may help your body to produce antibodies to fight
against COVID -19. We will check how many antibodies you make by taking blood
samples and testing them .
090177e1952b5e4c\Approved\Approved On: 07-Oct-2020 22:21 (GMT)
Page 63
FDA-CBER-2021-5683-0024556
CONSENT TO TAKE PART IN STUDY
CT05 -GSOP -RF04 7.0 Phase 1/2/3/4 Clinical Study Informed Consent Template (01-Jul-2019)
TMF Doc ID: 173.13 (Study); 173.07 (Country/Central); 173.23 (Site)
Sponsor Consent Version (Study) Phase 2/3, 07October2020
Protocol No: C4591001
CONFIDENTIAL Page:
6 of 20
This study is different from your regular medical care. The purpose of regular medical
care is to improve or otherwise manage your health, but the purpose of research is to
gather information to advance science and medicine and does not replace your regular
medical care. If you need medical care during your time in the stu dy, you should contact
your regular provider and inform the study team, as described later in this document.
Taking part in this study is voluntary (your choice). There is no penalty or change to
your regular medical care if y ou decide not to participate. You can choose to take part in
the study now, and then change your mind later at any time without losing any benefits
or medical care to which you are entitled. We encourage you to have conversations with
your family, caregivers, doctors, and study team about taking part in this study and
whether it is right for you. The study team will work w ith you to answer any questions
that you may have about the study.
You will receive a signed copy of this consent document for your records. Please keep
this consent document for your reference.
3. What is the purpose of this study?
The World Health Organiza tion (WHO) has declared COVID -19 to be a pandemic (a
disease that has spread all over the world and is affecting lots of people) ; finding a
vaccine to prevent COVID -19 is an urgent need. To test this investigational vaccine as
quickly as possible, this stu dy has been separated into 2 phase s. In both the phase s we
will try to see if the vaccine works to prevent COVID -19, as well as :
• Phase 1 where we choose which vaccines at which dose levels are safest and
make the most antibodies .
• Phase 2/3 where we look at one vaccine at one dose level in lots of people to
collect even more information about the safety of the vaccines and the amounts
of antibodies they produce .
You are being asked to take part in Phase 2/3.
The study will compare the results of the people who receive the study vaccine with
those who receive a placebo (a placebo does not contain any active ingredients). In this
study the placebo will be salt -water, also known as normal saline. Everyone in Phase
2/3 of the study will receive 2 injections of either:
090177e1952b5e4c\Approved\Approved On: 07-Oct-2020 22:21 (GMT)
Page 64
FDA-CBER-2021-5683-0024557
CONSENT TO TAKE PART IN STUDY
CT05 -GSOP -RF04 7.0 Phase 1/2/3/4 Clinical Study Informed Consent Template (01-Jul-2019)
TMF Doc ID: 173.13 (Study); 173.07 (Country/Central); 173.23 (Site)
Sponsor Consent Version (Study) Phase 2/3, 07October2020
Protocol No: C4591001
CONFIDENTIAL Page:
7 of 20
• Study vaccine followed by study vaccine
• Placebo followed by placebo
In Phase 2/3 everyone who receives the study vaccine will receive the same vaccine at
the same dose, that was chosen based on the results from Phase 1.
The study doctor will determine whether you are eligible for the study. This study will
require you to visit the study doctor to undergo study procedures and to provide
information about your health. You will also be required to contact the study doctor if
you experience any of the COVID -19 symptoms (explained later in this document).
4. How long will I participate in this study?
You could be in this study for up to about 26 months . You will need to visit the study site
6 to 7 planned times during the study, and any time after you have experienced COVID -
19 symptoms and are feeling better in about a month’s time .
5. How many people will take part in this study?
Approximately 44,193 healthy people could take part in the 2 phase s of this study. In
Phase 2/3 of the study up to 43,998 people will take part.
It is expected that about [number] people will participate in Phase 2/3 of the study at this
location.
6. What will happen during this study?
Before any study procedures begin, or before you begin preparing for the study, you will
be asked to read and sign this consent document.
After signing this consent document, the study doctor will check if you meet all of the
requirements to take part in this study. If you do not meet the requirements, you will not
be able to take part in the study and the study doctor will explain why this is the case.
Study Vaccine s
Once the study doctor has confirmed y ou meet the study requirements , you will be
randomly assigned (like flipping a coin) to receive the study vaccine or placebo. For
every 1 person who receive the study vaccine, 1 person will receive the placebo. No
one (including you, your personal doctor and the study team) can choose th is
assignment .
This is a n ‘observer -blind study’ , which means that you and the study doctor will not
know whether you are receiving the study vaccine or placebo , but the person who gives
you the vaccine will know because the vaccine and placebo do not look the same .
However, the syringe will be covered with a label so the co ntents are not visible and the
person that gives you the vaccine will not be able to talk about it with you. In case of
090177e1952b5e4c\Approved\Approved On: 07-Oct-2020 22:21 (GMT)
Page 65
FDA-CBER-2021-5683-0024558
CONSENT TO TAKE PART IN STUDY
CT05 -GSOP -RF04 7.0 Phase 1/2/3/4 Clinical Study Informed Consent Template (01-Jul-2019)
TMF Doc ID: 173.13 (Study); 173.07 (Country/Central); 173.23 (Site)
Sponsor Consent Version (Study) Phase 2/3, 07October2020
Protocol No: C4591001
CONFIDENTIAL Page:
8 of 20
urgent need, the study doctor can learn quickly whether you have received study
vaccine or placebo .
The study vaccine or placebo will b e given to you through an injection into the muscle in
your upper arm. Everyone will receive 2 injections, approximately 3 weeks apart. On the
days you receive the study vaccine or placebo, you will be asked to wait at the study
site for at least 30 minutes for observation after receiving the study vaccine or placebo .
Overview of Study Procedures and Assessments
The table below lists the tests and procedures or assessments that you will have done
in this research study. In addition to the visits listed, your study doctor may ask you to
come in for extra visit(s) if necessary, to protect your well -being.
090177e1952b5e4c\Approved\Approved On: 07-Oct-2020 22:21 (GMT)
Page 66
FDA-CBER-2021-5683-0024559
CONSENT TO TAKE PART IN STUDY
CT05 -GSOP -RF04 7.0 Phase 1/2/3/4 Clinical Study Informed Consent Template (01-Jul-2019)
TMF Doc ID: 173.13 (Study); 173.07 (Country/Central); 173.23 (Site)
Sponsor Consent Version (Study) Phase 2/3 07October2020
Protocol No: C4591001
CONFIDENTIAL Page:
9 of 20
For people taking part in Phase 2/3, the study doctor or nurse will:
Visit Number 1 2 3 4 5 6
Visit Description Study Vaccine
1 Study Vaccine
2 1-Month Visit 6-Month Visit 12-Month Visit 24-Month Visit
Ask about Medical history as well as date of birth,
sex, race and ethnicity X
Ask about medicines you are currently taking X X X X X X
Perform clinical assessment X
Record latest CD4 count and viral load (for HIV
positive participants only) X X X X X
Measure body temperature X X
Measure height and weight X
Urine pregnancy test (if appropriate) X X
Ask about other vaccinations you have had X X X X
Check you meet all the study requirements X X
Check contraceptives (if appropriate) X X X
Collect blood sample to test antibody levels ~20 mL ~20 mL ~20 mL ~20 mL ~20 mL
Take a nasal swab X X
Get the study injection , followed by a 30mins
observation period X X
Give you an e -diary or help you download one X
Vaccination e -diary completion for 7 days (if you
are part of chosen group to self-report potential
side effects daily for 7 days following each
vaccination) X X
COVID -19 illness e -diary completion X X X X X X
Ask how you are feeling generally X X X X X X
090177e1952b5e4c\Approved\Approved On: 07-Oct-2020 22:21 (GMT)
Page 67
FDA-CBER-2021-5683-0024560
CONSENT TO TAKE PART IN STUDY
CT05 -GSOP -RF04 7.0 Phase 1/2/3/4 Clinical Study Informed Consent Template (01-Jul-2019)
TMF Doc ID: 173.13 (Study); 173.07 (Country/Central); 173.23 (Site)
Sponsor Consent Version (Study) Phase 2/3 07October2020
Protocol No: C4591001
CONFIDENTIAL Page:
10 of 20
Blood samples for antibody testing
You will have blood taken 5 times during the planned visits of the study. This will be
used to test if you already had antibodies against the coronavirus that causes COVID -
19 when you enrolled in the study and may be used to test your antibody levels after
vaccination . About 20mL of blood (about 4 teaspoons) will be collected f rom your arm
using a needle at these visits.
E-Diary
At Visit 1, the study team will show you how to fill in an electronic diary (or e -Diary). We
will either give you a device (a bit like a mobile phone) or ask you to download an
application (‘app’) to your smart phone if you have one. The device/app is secure and
your confidentiality will be maintained.
There are 2 parts to the e -Diary. Everyone will need to complete the COVID -19 illness
part of the e -Diary on the device or app on your smartphone. The COVID -19 illness e -
Diary will prompt you to record any COVID -19 symptoms (see below) every 7 days or at
any time you have COVID -19 symptoms. You may also receive text messages to the
device or your own smartphone, or emails (if you provide your email address) to remi nd
you to complete the COVID -19 illness part of the e -Diary.
If you are part of a subset of participants, you will also be instructed by the study team
to complete the vaccination part of the e-Diary for 7 days after each vaccination, once a
day in the eve ning with the first day being the day of the vaccination.
You will be given a thermometer and a measuring device to take home. You will use
the thermometer to measure your temperature under your tongue and you will use the
measuring device to measure any redness or swelling where the injection was given.
You will need to record these measurements in the vaccination part of the e-Diary.
The vaccination part of the e-Diary will also ask other questions about potential side
effects you may have after the injection. If you have any severe symptoms after your
vaccination, you should contact your study doctor and the study doctor or nurse may
schedule an extra visit.
It is very important that you complete the e -Diary regularly as instructed. If you do not,
your study doctor or nurse will contact you to check how you are .
Urine pregnancy test
If you’re a woman who is able to have children , you will have a urine pregnanc y test to
check you are not pregnant before you get the study injection .
090177e1952b5e4c\Approved\Approved On: 07-Oct-2020 22:21 (GMT)
Page 68
FDA-CBER-2021-5683-0024561
CONSENT TO TAKE PART IN STUDY
CT05 -GSOP -RF04 7.0 Phase 1/2/3/4 Clinical Study Informed Consent Template (01-Jul-2019)
TMF Doc ID: 173.13 (Study); 173.07 (Country/Central); 173.23 (Site)
Sponsor Consent Version (Study) Phase 2/3 07October2020
Protocol No: C4591001
CONFIDENTIAL Page:
11 of 20
What happens if I have positive nasal swab test result?
Nasal swabs obtained during the study (at Visits 1 and 2, and at the time of a potential
COVID -19 illness – see below) will be tested in a research laboratory. P ositive results
from the Visit 1 and 2 swabs, and all results from the illness visit swabs, will be provided
to your study doctor, but this will take some time so you should not rely on these for
medical treatment . If you has a positive nasal swab test result for the coronavirus that
causes COVID -19, either at Visit 1 or any time between Visit 1 and Visit 2 , but with no
potential COVID -19 related symptoms , you will continue to receive the second study
vaccine as normal. However, if the positive COVID -19 test result is accompanied by
potential COVID -19 related symptoms, you will not be given the second study vaccine
but will be requested to remain in the study.
If You Get COVID -19 Symptoms
If you get any of the following you must contact the study doctor straight away .
Note that this is not instead of your routine medical care. If you feel unwell
enough that you would normally see a healthcare professional, please contact
your usual provider , as well as the study doctor .
• A diagnosis of COVID -19;
• Fever;
• New or increased cough;
• New or increased shortness of breath;
• Chills ;
• New or increased muscle pain ;
• New l oss of taste/smell ;
• Sore throat ;
• Diarrhea;
• Vomiting .
The study doctor may ask you to have a telephone conversation , video call or to visit
the site to talk about how you are feeling and if you have needed any other medical
care. They will also ask you to take a nose swab or take one from you to check for the
coronavirus (only once during each illness) . We will give you separate instructions about
how to take a nose swab yourself and how to ship the swab to the laboratory if needed .
The result from this swab will be provided to the study doctor once it is available, but
this will take some time, and cannot be used to diagnose you with COVID -19. This is
why it is important that you contact your usual provider if you have COVID -19 symptoms
and think you need medical care.
090177e1952b5e4c\Approved\Approved On: 07-Oct-2020 22:21 (GMT)
Page 69
FDA-CBER-2021-5683-0024562
CONSENT TO TAKE PART IN STUDY
CT05 -GSOP -RF04 7.0 Phase 1/2/3/4 Clinical Study Informed Consent Template (01-Jul-2019)
TMF Doc ID: 173.13 (Study); 173.07 (Country/Central); 173.23 (Site)
Sponsor Consent Version (Study) Phase 2/3 07October2020
Protocol No: C4591001
CONFIDENTIAL Page:
12 of 20
If you are diagnosed with COVID -19, for the purposes of the study, the study doctor will
contact your usual provider , and any facility where you are treated , to obtain details and
collect medical records : by signing this informed consent document, you agree to this .
The study doctor will arrange an extra visit to the study site about a month after you
became unwell and you will give another 20 mL (about 4 teaspoons) blood sample to
test your antibody levels.
After the study
The study vaccine is available only during this study and not after the study is over.
7. Are there any special instructions to follow for this study?
It is important you follow all the instructions given to you by the study nurse or doctor
and tell them if:
• You don’t understand anything about the study
• You are not able to comply with th e study requirements
• There are changes in your health
• You take any new medications or receive any other vaccines
• You are going away for a long period
• You wish to take part in another research study
8. What are the possible risks and discomforts of this study?
Any research has some risks, which may include negative effects that could make you
unwell or uncomfortable and even potentially be serious or life -threatening. All research
participants taking part in the study will be watched carefully for any negative effects;
however, the study team does not know all the effects that the study vaccine may have
on you.
If you take part in this study, the most likely risks or discomforts to happen to you are
discussed below.
It is important that you report to the study team all symptoms and side effects as
soon as they occur. Phone numbers for the study team are listed in [Section 1 ] of
this consent document.
Study Vaccine Risks
In early studies, these vaccines were administered to approximately 350 people (up
until August 06th 2020) . In the ongoing Phase 2/3 part of the study that you are
090177e1952b5e4c\Approved\Approved On: 07-Oct-2020 22:21 (GMT)
Page 70
FDA-CBER-2021-5683-0024563
CONSENT TO TAKE PART IN STUDY
CT05 -GSOP -RF04 7.0 Phase 1/2/3/4 Clinical Study Informed Consent Template (01-Jul-2019)
TMF Doc ID: 173.13 (Study); 173.07 (Country/Central); 173.23 (Site)
Sponsor Consent Version (Study) Phase 2/3 07October2020
Protocol No: C4591001
CONFIDENTIAL Page:
13 of 20
considering joining, 36,576 people have been enrolled (up until October 5th 2020),
approximately half of whom will have received the study vaccine and half of whom will
have received placebo. Based on these studies , the following risks have been
determined to be caused by study vaccine:
Injection site pain, fatigue (tiredness), increased body temperature (fever), chills,
headache and muscle aches.
Other risks that commonly occur following vaccines in general include:
Injection site redness, swelling and itching; loss of appetite, joint aches and sweating.
As in all research studies, the COVID -19 vaccines may involve risks that might be
expected based on results from studies of similar vaccines, as well as risks that are
currently unknown.
As with any vaccine given by injection, people may have an allergic reaction. The
allergic reaction could be minor (rashes) or more severe (swelling of the face or lips
and/or shortness of breath). A severe allergic shock (anaphylactic shock) could occur.
Very rarely, people may have a nervous system reaction (for example, a seizure) after a
vaccine.
Therefore, it is important that you report all symptoms and side effects that you
experience as soon as they occur, whether or not you think they are caused by the
study vaccine.
Due to the way in which the study vaccines are made, they cannot cause COVID -19
disease.
If I catch COVID -19 disease, could the vaccine make it worse?
For some other vaccines tested in animals against similar viruses (but not the
coronavirus that causes COVID -19), there have been reports of the illness being more
severe in the animals that received the vaccine than in those that did not. So far this has
not been seen with COVID -19 vaccines, but at the moment we do not know whether the
study vaccines could make a later COVID -19 illness more severe. That is one of the
reasons why you are asked to contact your study doctor if you develop symptoms that
might be c aused by COVID -19 (for example, fever, cough, shortness of breath).
Placebo Risks
As the placebo injection contain s salt -water and no active ingredients, the chances of
having the side effects mentioned above are less likely. In other studies using the same
placebo , some people who received the placebo injection reported pain, bruising,
swelling and redness at the site of injectio n.
Risks from Study Procedures
090177e1952b5e4c\Approved\Approved On: 07-Oct-2020 22:21 (GMT)
Page 71
FDA-CBER-2021-5683-0024564
CONSENT TO TAKE PART IN STUDY
CT05 -GSOP -RF04 7.0 Phase 1/2/3/4 Clinical Study Informed Consent Template (01-Jul-2019)
TMF Doc ID: 173.13 (Study); 173.07 (Country/Central); 173.23 (Site)
Sponsor Consent Version (Study) Phase 2/3 07October2020
Protocol No: C4591001
CONFIDENTIAL Page:
14 of 20
Risks and possible discomforts you might have from the study procedures include:
• Blood samples: The risks and possible discomforts involved in taking blood
include pain from inserting the needle, or less often, swelling, bruising, or
infection around the vein where the blood is collected. You may feel dizzy or
may faint. If you have a previous history of feeling dizzy or fainting during blood
sample collection, you should talk to the study doctor.
• Nasal S wabs : The risks and possible discomforts invo lved in takin g nasal swabs
may include pain or general discomfort. Sometimes it may cause the nose to
bleed.
Pregnancy -Related Risks; Use of Birth Control
If you are currently pregnant, plan to become pregnant, or are breastfeeding a child, you
should not join this study.
If you are able to have children and you are sexually active, you must use birth control
consistently and correctly for at least 28 days after you receive your last injection . This
applies to men as well as women who take part in the research study. The study doctor
will discuss with you the methods of birth control that you should use while you are in
this research study and will help you select the method(s) that is appropriate for you.
The study doctor will also check that you understand how to use th e birth control
method and may review this with you at each of your research study visits.
Birth control methods, even when used properly are not perfect. If you or your partner
becomes pregnant during the research study, or you want to stop your requi red birth
control during the research study, you should tell the study doctor immediately . You
may b e withdrawn from the research study if you stop using birth control or you become
pregnant.
Pregnancy Follow -up
If you or your partner become pregnant during the study, up until 6 months after you last
study injection , please tell the study doctor immediately . Please also tell the doctor who
will be taking care of you/your partner during the pregnancy that you took part in this
study. The study doctor will ask if you/your partner or your pregnancy doctor is willing to
provide updates on the progress of the pregnancy and its outcome. If you/your partner
agree, this information will be provided to BioNTech/ Pfizer for safety follow -up.
9. What are possible benefits of this study?
It is not known yet whether the study vaccines may reduce the chance of you getting
COVID -19, so you may not directly benefit from participating in the study. For this
090177e1952b5e4c\Approved\Approved On: 07-Oct-2020 22:21 (GMT)
Page 72
FDA-CBER-2021-5683-0024565
CONSENT TO TAKE PART IN STUDY
CT05 -GSOP -RF04 7.0 Phase 1/2/3/4 Clinical Study Informed Consent Template (01-Jul-2019)
TMF Doc ID: 173.13 (Study); 173.07 (Country/Central); 173.23 (Site)
Sponsor Consent Version (Study) Phase 2/3 07October2020
Protocol No: C4591001
CONFIDENTIAL Page:
15 of 20
reason, you should still follow local recommendations about how to avoid COVID -19.
Information learned from the research study may help other people in the future
10. What will happen to my blood and nasal swab samples?
Your blood and nasal swab samples will be used only for scientific research. Each
sample will be labeled with a code so that the laboratory workers testing the samples
will not know who you are. Some of the samples may be stored for future testing and
may be kept for up to 15 ye ars after the study ends, at which time they will be
destroyed. In addition to testing for this study, any samples left over after the study is
complete may be used for additional research related to the development of products.
No testing of your DNA will be performed.
You may request that your samples, if they can be identified, be destroyed at any time.
Any data already collected from those samples will still be used for the study. The
samples will remain the property of BioNTech/ Pfizer and may be share d with other
researchers as long as confidentiality is maintained and no testing of your DNA will be
performed. You will not be told of additional tests, nor will you receive results of any of
these tests.
11. What other choices do I have if I do not join this study?
This study is for research purposes only. Your alternative is to not take part in this
study .
12. What happens if I am injured during this study?
For mandatory research injury language, < click here > (retain this link in the study -level
ICD). The country -specific research injury language must be inc luded verbatim in the
country -level ICD .
13. What if I join this study and then change my mind?
If you agree to participate and then change your mind for any reason, you are free to
stop participating at any time. Your decision will not affect your regular medical care or
any benefits to which you are entitled. Tell the study doctor if you are thinking about
stopping or decide to stop so that you can end participation in the study in the safest
way.
While you are participating, the study team will tell you in a timely manner if new
information is learned during the course of the study that could change your mind about
continuing in this study. If you decide to withdraw from the study, you may be asked to
continue to participate in the study procedures e ven though you would no longer receive
the study vaccine.
090177e1952b5e4c\Approved\Approved On: 07-Oct-2020 22:21 (GMT)
Page 73
FDA-CBER-2021-5683-0024566
CONSENT TO TAKE PART IN STUDY
CT05 -GSOP -RF04 7.0 Phase 1/2/3/4 Clinical Study Informed Consent Template (01-Jul-2019)
TMF Doc ID: 173.13 (Study); 173.07 (Country/Central); 173.23 (Site)
Sponsor Consent Version (Study) Phase 2/3 07October2020
Protocol No: C4591001
CONFIDENTIAL Page:
16 of 20
If you agree to continue with the study, information about your health will continue to be
collected as described in [Section 6].
If you decide to stop participating in this study, you must notify the study doctor. The
study team will explain what other procedures or discussions would occur.
Sometimes the study doctor or BioNTech/ Pfizer may decide to take you out of the study
(even if you do not agree ) if:
• You are unable or unwilling to follow the instructions of the study team;
• The study doctor decides that the study is not in your best interest or that you are no
longer eligible to participate; or
• The study is stopped by BioNTech/Pfizer , the institutional review board (IRB) or
independent ethics committee (IEC) (a group of people who review the study to
protect your rights), or by a government or regulatory agency .
The study team will give you a Privacy Supplement, which is considered part of this
consent document. It describes what happens to your personal information (including
your biological samples) and how it may be used if you withdraw from the study.
14. What will I have to pay for if I take part in this study?
You will not need to pay for any of the study vaccines (COVID -19 Vaccine or placebo),
study -related procedures, or study visits.
15. Will I be paid for taking part in this study?
You will not receive any payment for taking part in this study. However, for each visi t
you complete, you will be reimbursed by the study site to cover reasonable expenses
(for example, parking, meals, travel) that you have as a result of taking part in this
study. You will be reimbursed by [enter, as applicable, method of reimbursement;
amounts; and reimbursement schedule; note whether receipts are required].
BioNTech/Pfizer may use information resulting from the study to develop products or
processes from which they may make a profit. There are no plans to pay you or provide
you with any products developed from this research. BioNTech/Pfizer will own all
products or processes that are developed using information from the study.
16. What will happen to my personal information?
<click here > for language to be inserted into this section. This text must be inserted
verbatim. Any requested c hanges must be approved by Clinical Development Legal. Note
that the Privacy Supplement follows this consent document, after the signature section.
090177e1952b5e4c\Approved\Approved On: 07-Oct-2020 22:21 (GMT)
Page 74
FDA-CBER-2021-5683-0024567
CONSENT TO TAKE PART IN STUDY
CT05 -GSOP -RF04 7.0 Phase 1/2/3/4 Clinical Study Informed Consent Template (01-Jul-2019)
TMF Doc ID: 173.13 (Study); 173.07 (Country/Central); 173.23 (Site)
Sponsor Consent Version (Study) Phase 2/3 07October2020
Protocol No: C4591001
CONFIDENTIAL Page:
17 of 20
17. Where can I find additional information about this study or the
study results?
A description of this clinica l trial will be available on http://www.ClinicalTrials.gov , as
required by U.S. Law. This Web site will not include information that can identify you. At
most, the Web site will include a summary of the results . You can search this Web site
at any time.
The study results, when available, may also be found on www.pfizer.com and
https://www.clinicaltrialsregister.eu/ .
In addition, a plain summary of the study results will be made available in the EU database
at [insert link to the database ]. This information will be provided no matter what the study’s
outcome. To the extent possible, you will be able to access these summaries in the EU
database soon after they become availa ble using the following EU trial number for the
study: [ insert trial number ].
These Web sites are in English only. If you need assistance understanding these Web
sites, please ask a member of the study team.
BioNTech/Pfizer will provide the study doctor with information about the study results
when all participants have completed the study. At that time, certain of your individual
study results may be given to you or your doctor (if different from the study doctor) in
accord ance with applicable law , but will not be given to your family, your employer or
any insurance company .
If any exploratory research is done, it may not be possible to link any results from that
exploratory research to specific individuals, including you. B ioNTech/Pfizer does not
plan to return information from any exploratory research to you, the study doctor, or
your doctor (if different from the study doctor).
18. Signatures
Agreement to Participate and to Process Data
1. I confirm I have read (or, if I cannot read, a study team member has read to me)
and understand this consent document for the study described above and have
had the opportunity to ask questions. I have had enough time to review this
consent document. I also have had an opportunity to ask about the details of the
study and to decide whether or not to participate.
2. I have read and understand the Privacy Supplement. I understand that taking part
in the study will require the processing (including colle ction, use, transfer, storage,
090177e1952b5e4c\Approved\Approved On: 07-Oct-2020 22:21 (GMT)
Page 75
FDA-CBER-2021-5683-0024568
CONSENT TO TAKE PART IN STUDY
CT05 -GSOP -RF04 7.0 Phase 1/2/3/4 Clinical Study Informed Consent Template (01-Jul-2019)
TMF Doc ID: 173.13 (Study); 173.07 (Country/Central); 173.23 (Site)
Sponsor Consent Version (Study) Phase 2/3 07October2020
Protocol No: C4591001
CONFIDENTIAL Page:
18 of 20
analysis and reporting) of my personal information, as explained in the Privacy
Supplement. I understand and agree to the processing of my personal information
within and outside my country of residence for health care, medic al research
and/or regulatory purposes.
3. I understand that taking part is voluntary and that I am free to stop taking part in
this study or to withdraw my consent to the processing of my personal information
at any time. I do not need to give any reaso n and my regular medical care and
legal rights will not be affected. However, even if I withdraw my consent to
processing, my personal information held at that time may be kept to comply with
laws and regulations and to maintain the integrity of the study. I also understand
that my biological samples may not be able to be destroyed because they may no
longer be traceable to me, may have already been used, or may have been given
to a third party.
4. I agree to the study team accessing my medical history, i ncluding information from
medical records and test results and any medical treatment I receive during the
course of the study, and if necessary, contacting my doctor or any other health
care providers treating me for access to such information.
5. I unde rstand that BioNTech/Pfizer and/or others working with or on behalf of
BioNTech/Pfizer , institutional review boards (IRBs) or independent ethics
committees (IECs) , and regulatory agencies may need access to personal
information about me generated at the st udy site or collected by the study team for
the study and any other research. I agree that they may have access to my
personal information.
6. I do not give up any of my legal rights by signing this consent document. I have
been told that I will receive a signed and dated copy of this document.
7. I agree to take part in the study described in this document.
_________________________________________
Printed name of participant
________________________________________________ ______________
Signature of participant Date of signature§
(If no legally acceptable representative is used)
§Participant must personally date their signature.
090177e1952b5e4c\Approved\Approved On: 07-Oct-2020 22:21 (GMT)
Page 76
FDA-CBER-2021-5683-0024569
CONSENT TO TAKE PART IN STUDY
CT05 -GSOP -RF04 7.0 Phase 1/2/3/4 Clinical Study Informed Consent Template (01-Jul-2019)
TMF Doc ID: 173.13 (Study); 173.07 (Country/Central); 173.23 (Site)
Sponsor Consent Version (Study) Phase 2/3 07October2020
Protocol No: C4591001
CONFIDENTIAL Page:
19 of 20
Person Obtaining Consent:
____________________________________
Printed Name of the Person Conducting the
Consent Discussion
________________________________________ _______________
Signature of the P erson Conducting the Date of signature
Consent Discussion †
†The investigator, or an appropriately qualified and trained person designated by the
investigator to conduct the informed consent process, must sign and date the consent
document during the same discussion when the participant signs the consent
document .
090177e1952b5e4c\Approved\Approved On: 07-Oct-2020 22:21 (GMT)
Page 77
FDA-CBER-2021-5683-0024570
PRIVACY SUPPLEMENT
CT05 -GSOP -RF04 7.0 Phase 1/2/3/4 Clinical Study Informed Consent Template (01-Jul-2019)
TMF Doc ID: 173.13 (Study); 173.07 (Country/Central); 173.23 (Site)
Sponsor Consent Version (Study) Phase 2/3 07October2020
Protocol No: C4591001
CONFIDENTIAL Page:
20 of 20
PRIVACY SUPPLEMENT
For mandatory country -specific data privacy language to be inserted in this Privacy
Supplement, <click here > (retain this link in the study -level ICD). The country -specific
data privacy language must be included verbatim in the country -level ICD. Any requested
changes must be approved by Clinical Development Legal.
Who will use my personal information, how will th ey use it, and where will it be
stored?
[Mandatory study language – retain the below paragraph and delete this green text before
finalis ation ]
Any personal information collected about you during this study will be entered into
records, including health records, maintained by the study team at your study site. Your
records that include information that directly identifies you may be uploaded to se cure
systems maintained by a third party engaged by BioNTech/ Pfizer so that
BioNTech/ Pfizer and/or BioNTech/ Pfizer representatives can review and verify study
data. Some of the uploaded records will be kept for XX years. The remaining records
that are uploaded will be temporary and removed from the secure system after the
study is over.
090177e1952b5e4c\Approved\Approved On: 07-Oct-2020 22:21 (GMT)
Page 78
FDA-CBER-2021-5683-0024571
CT05 -GSOP -RF04
7.0 PHASE 1/2/3/ CLINICAL STUDY
INFORMED CONSENT TEMPLATE 01-Jul-2019
Protocol Number: C4591001 ICD Version Date : Phase 1, 09Oct 2020
Study
Country
Site Language: English Center ID: Not Applicable
Country: Not
Applicable
ICD Derived From: Study level, Phase 1, 09Sep2020
CT05 -GSOP -RF04 7.0 Phase 1/2/3/4 Clinical Study Informed Consent Template (01-Jul-
2019)
TMF Doc ID: 173.13 (Study); 173.07 (Country/Central); 173.23 (Site)
Sponsor Consent Version (Study) Phase 1 09Oct ober2020
Protocol No: C4591001
CONFIDENTIAL Page:
1 of 21
090177e195308995\Approved\Approved On: 09-Oct-2020 16:27 (GMT)
Page 79
FDA-CBER-2021-5683-0024572
CONSENT TO TAKE PART IN STUDY
CT05 -GSOP -RF04 7.0 Phase 1/2/3/4 Clinical Study Informed Consent Template (01-Jul-
2019)
TMF Doc ID: 173.13 (Study); 173.07 (Country/Central); 173.23 (Site)
Sponsor Consent Version (Study) Phase 1 09Oct ober2020
Protocol No: C4591001
CONFIDENTIAL Page:
2 of 21
Table of Contents
This Table of Contents describes the different sections of this consent document. Be
sure to read through all sections of this consent document before making your decision
about whether or not to participate in this study.
Section Page
1. Key study information and contact information 4
2. Brief summary of this study 5
3. What is the purpose of this study? 6
4. How long will I participate in this study? 7
5. How many people will take part in this study? 7
6. What will happen during this study? 7
7. Are there any special instructions to follow for this study? 13
8. What are the possible risks and discomforts of this study? 13
9. What are the possible benefits of this study? 15
10. What will happen to my blood and nasal swab samples? 16
11. What other choices do I have if I do not join this study? 16
12. What happens if I am injured during this study? 16
13. What if I join this study and then change my mind? 16
14. What will I have to pay for if I take part in this study? 17
15. Will I be paid for taking part in this study? 17
090177e195308995\Approved\Approved On: 09-Oct-2020 16:27 (GMT)
Page 80
FDA-CBER-2021-5683-0024573
CONSENT TO TAKE PART IN STUDY
CT05 -GSOP -RF04 7.0 Phase 1/2/3/4 Clinical Study Informed Consent Template (01-Jul-
2019)
TMF Doc ID: 173.13 (Study); 173.07 (Country/Central); 173.23 (Site)
Sponsor Consent Version (Study) Phase 1 09Oct ober2020
Protocol No: C4591001
CONFIDENTIAL Page:
3 of 21
16. What will happen to my personal information? 17
17. Where can I find additional information about this study or the
study results? 18
18. Signatures 18
Privacy Supplement
090177e195308995\Approved\Approved On: 09-Oct-2020 16:27 (GMT)
Page 81
FDA-CBER-2021-5683-0024574
CONSENT TO TAKE PART IN STUDY
CT05 -GSOP -RF04 7.0 Phase 1/2/3/4 Clinical Study Informed Consent Template (01-Jul-
2019)
TMF Doc ID: 173.13 (Study); 173.07 (Country/Central); 173.23 (Site)
Sponsor Consent Version (Study) Phase 1 09Oct ober2020
Protocol No: C4591001
CONFIDENTIAL Page:
4 of 21
1. Key Study Information and Contact Information
The study team will address any questions, concerns or complaints you may have
before, during and after you complete the study. The study team includes the study
doctor, nurses, and others who work with the study doctor.
Phone numbers for the study team are listed below under “Study Site Contact
Information.” You also will be given a card with important emergency contact
information, including a 24 -hour number. Show this card to any doctor, nurse or
other health care provi der if you seek emergency care while you are taking part in this
study. This card includes information about the study that will help them treat you.
If you have any general questions about your rights as a study participant, or would like
to obtain inform ation from, offer suggestions to, or speak with someone not directly
involved in the study, you may contact [For the site -level ICD , include as appropriate:
the Institutional Review Board or the Independent Ethics Committee, patient rights
advocate, and/or bioethicist ] listed below.
Name of Study: A PHASE 1/2/3, PLACEBO -CONTROLLED, RANDOMIZED,
OBSERVER -BLIND, DOSE -FINDING STUDY TO EVALUATE THE SAFETY,
TOLERABILITY, IMMUNOGENICITY, AND EFFICACY OF SARS -COV -2 RNA
VACCINE CANDIDATES AGAINST COVID -19 IN HEALTHY INDIVIDUALS
[Institution] Study Number:
Sponsor Study Number: C4591001
Name of Company Sponsoring the Study: BioNTech. Pfizer is conducting the study
for BioNTech
Name of Principal Investigator (Study Doctor):
Study Site Contact Information:
Contact Person:
Address:
Phone Number (Normal Business Hours):
Phone Number (Off -Hours or Emergency):
[Complete the following entries for the site -level ICD as appropriate. ]
[Institutional Review Board or Independent Ethics Committee ] Contact
Information:
Contact Person:
Address:
090177e195308995\Approved\Approved On: 09-Oct-2020 16:27 (GMT)
Page 82
FDA-CBER-2021-5683-0024575
CONSENT TO TAKE PART IN STUDY
CT05 -GSOP -RF04 7.0 Phase 1/2/3/4 Clinical Study Informed Consent Template (01-Jul-
2019)
TMF Doc ID: 173.13 (Study); 173.07 (Country/Central); 173.23 (Site)
Sponsor Consent Version (Study) Phase 1 09Oct ober2020
Protocol No: C4591001
CONFIDENTIAL Page:
5 of 21
Phone Number:
Patient Rights Advocate:
Contact Person:
Address:
Phone Number:
Bioethicist:
Contact Person:
Address:
Phone Number:
2. Brief Summary of this Study
This is a research study involving both Pfizer and B ioNTech . Pfizer and BioNTech are
separate companies who are cooperating to perform this study. Pfizer is responsible for
conducting this study. B ioNTech is the regulatory sponsor of this study. Funding for this
study is provided by BioNTech and Pfizer and [the study doctor/institution] will be paid
to conduct this study.
A new respiratory disease appeared in Wuhan, China in December 2019 and has since
rapidly spread to many other countries around the world. In January 2020, the cause of
this disease was found to be a new Coronavirus ; and the disease it causes was named
COVID -19 (Coronavirus disease 2019). Since then, many companies around the World
have qu ickly started to look for treatments and ways to prevent COVID -19. There are no
currently licensed (approved for sale) vaccines for COVID -19.
Vaccines help your body to produce antibodies to help you to fight off a disease . This
research study involves 2 investigational vaccines to prevent COVID -19, that will be
given to healthy volunteers . The vaccines are given by injection. The vaccines are
slightly different but work in the same way. The study will also test each of these
vaccines at different dose levels (amounts of vaccine).
These vaccines do not contain the whole virus, or the parts of the virus that can make
you ill, instead the vaccines are made up of part of the virus’s genetic code, surrounded
by fatty particles called lipids. They use your own c ells’ protein making machinery to
produce some, or all , of the spike protein seen on the outside of the virus. This spike
protein, made by your own body, may help your body to produce antibodies to fight
against COVID -19. We will check how many antibodies you make by taking blood
samples and testing them .
090177e195308995\Approved\Approved On: 09-Oct-2020 16:27 (GMT)
Page 83
FDA-CBER-2021-5683-0024576
CONSENT TO TAKE PART IN STUDY
CT05 -GSOP -RF04 7.0 Phase 1/2/3/4 Clinical Study Informed Consent Template (01-Jul-
2019)
TMF Doc ID: 173.13 (Study); 173.07 (Country/Central); 173.23 (Site)
Sponsor Consent Version (Study) Phase 1 09Oct ober2020
Protocol No: C4591001
CONFIDENTIAL Page:
6 of 21
This study is different from your regular medical care. The purpose of regular medical
care is to improve or otherwise manage your health, but the purpose of research is to
gather information to advance science and medicine and does not replace your regular
medical care. If you need medical care during your time in the study, you should contact
your regular provider and inform the study team, as described later in this document.
Taking part in thi s study is voluntary (your choice). There is no penalty or change to
your regular medical care if y ou decide not to participate. You can choose to take part in
the study now, and then change your mind later at any time without losing any benefits
or medica l care to which you are entitled. We encourage you to have conversations with
your family, caregivers, doctors, and study team about taking part in this study and
whether it is right for you. The study team will work with you to answer any questions
that y ou may have about the study.
You will receive a signed copy of this consent document for your records. Please keep
this consent document for your reference.
3. What is the purpose of this study?
The World Health Organization (WHO) has declared COVID -19 to be a pandemic (a
disease that has spread all over the world and is affecting lots of people) ; finding a
vaccine to prevent COVID -19 is an urgent need. To test this investigational vaccine as
quickly as possible, this study has been separated into 2 phases . In both the phases ,
we will try to see if the vaccine works to prevent COVID -19, as well as :
• Phase 1 where we choose which vaccines at which dose levels are safest and
make the most antibodies .
• Phase 2/3 where we look at one vaccine at one dose level in lots of people to
collect more information about the safety of the vaccines and the amounts of
antibodies they produce .
You are being asked to take part in Phase 1.
The study will compare the results of the people who receive the study vaccine with
those who receive a placebo (a placebo does not contain any active ingredients). In this
090177e195308995\Approved\Approved On: 09-Oct-2020 16:27 (GMT)
Page 84
FDA-CBER-2021-5683-0024577
CONSENT TO TAKE PART IN STUDY
CT05 -GSOP -RF04 7.0 Phase 1/2/3/4 Clinical Study Informed Consent Template (01-Jul-
2019)
TMF Doc ID: 173.13 (Study); 173.07 (Country/Central); 173.23 (Site)
Sponsor Consent Version (Study) Phase 1 09Oct ober2020
Protocol No: C4591001
CONFIDENTIAL Page:
7 of 21
study the placebo will be salt -water, also known as normal saline. Everyone in Phase 1
of the study will recei ve 2 injections of either:
• Study vaccine followed by study vaccine
• Placebo followed by placebo
You will be assigned to one of the groups investigating one of the study vaccine s, at
one of the vaccine dose levels. All groups will have some people who get 2 placebo
injections .
The study doctor will determine whether you are eligible for the study. This study will
require you to visit the study doctor to undergo study procedures and to provide
information about your health. You will also be required to contact the study doctor if
you experience any of the COVID -19 symptoms (explained later in this document).
4. How long will I participate in this study?
You could be in this study for up to about 26 months . You will need to visit the study site
at 11 planned times during the study, and any time after you have experienced COVID -
19 symptoms and are feeling better in about a month ’s time.
5. How many people will take part in this study?
Approximately 44,193 healthy people could take part in the 2 phase s of this study . In
Phase 1 of the study up to 195 people will take part.
It is expected that about [number] people will participate in Phase 1 of the study at this
location.
6. What will happen during this study?
Before any study procedures begin, or before you begin preparing for the study, you will
be asked to read and sign this consent document.
This study wil l be one of the first studies in which these COVID -19 vaccines will be
given to humans , for that reason, extra safety checks will be done on the first groups of
people that take part in Phase 1. These extra safety checks are explained along with
the other study procedures below.
Screening Visit
After signing this consent document, you will have a screening assessment visit to find
out if you meet all of the requirements to take part in this stud y. If you do not meet the
requirements, you will not be able to take part in the study and the study doctor will
explain why this is the case.
090177e195308995\Approved\Approved On: 09-Oct-2020 16:27 (GMT)
Page 85
FDA-CBER-2021-5683-0024578
CONSENT TO TAKE PART IN STUDY
CT05 -GSOP -RF04 7.0 Phase 1/2/3/4 Clinical Study Informed Consent Template (01-Jul-
2019)
TMF Doc ID: 173.13 (Study); 173.07 (Country/Central); 173.23 (Site)
Sponsor Consent Version (Study) Phase 1 09Oct ober2020
Protocol No: C4591001
CONFIDENTIAL Page:
8 of 21
The screening visit will include taking a total of 40 mL (about 8 teaspoons) of blood .
This will be used to check you are healthy and that you have no infections such as HIV
or hepatitis (liver infection) , and also to check if you have had COVID -19 before .
Study Vaccine s
Once the study doctor has confirmed you meet the study requirements , you will be
randomly assigned (like rolling a dice ) to receive the study vaccine or placebo. For
every 4 people who receive the study vaccine at the first dose, 1 person will receive the
placebo. No one (incl uding you, your personal doctor and the study team) can choose
this assignment .
This is a n ‘observer -blind study’ , which means that you and the study doctor will not
know whether you are receiving the study vaccine or placebo , but the person who gives
you the vaccine will know because the vaccine and placebo do not look the same .
However, the syringe will be covered with a label so the co ntents are not visible and the
person that gives you the vaccine will not be able to talk about it with you. In case of
urgent need, the study doctor can learn quickly whether you have received study
vaccine or placebo .
The study vaccine or placebo will be given to you through an injection into the muscle in
your upper arm. Everyone will receive 2 injections , approximately 3 weeks apart. On the
days you receive the study vaccine or placebo, you will be asked to wait at the study
site for at least 30 minutes for observation after receiving the study vaccine or placebo .
If you are one of the first people to take part, you will be asked to wait at the study site
for at least 4 hours for observation after receiving the study vaccine or placebo .
Overview of Study Procedures and Assessments
The table below lists the tests and procedures or assessments that you will have done
in this research study. In addition to the visits listed, your study doctor ma y ask you to
come in for extra visit(s) if necessary, to protect your well -being.
090177e195308995\Approved\Approved On: 09-Oct-2020 16:27 (GMT)
Page 86
FDA-CBER-2021-5683-0024579
CONSENT TO TAKE PART IN STUDY
CT05 -GSOP -RF04 7.0 Phase 1/2/3/4 Clinical Study Informed Consent Template (01-Jul-2019)
TMF Doc ID: 173.13 (Study); 173.07 (Country/Central); 173.23 (Site)
Sponsor Consent Version (Study) Phase 1 09Oct ober2020
Protocol No: C4591001
CONFIDENTIAL Page:
9 of 21
For people tak ing part in Phase -1, the study doctor or nurse will :
Visit Number Screening 1 2 3 4 5 6 7 8 9 10
Visit Description Screening Study
Vaccine
1 Next -Day
Visit 1-
Week
Visit Study
Vaccine
2 1-
Week
Visit 2-
Week
Visit 1-
Month
Visit 6-
Month
Visit 12-
Month
Visit 24-
Month
Visit
Ask about Medical history as well as
date of birth, sex, race and ethnicity X
Ask about medicines you are currently
taking X X X X X X X X X X X
Measure height and weight X
Measure pulse rate, blood pressure
and body temperature ; perform
physical examination (after screening,
only if needed) X X X X X X X
Collect a blood sample to check for
prior COVID -19 infection ~20 mL
Collect a blood sample for a n extra
safety check ~10 mL ~10 mL ~10 mL ~10 mL ~10 mL
Collect a b lood sample to check for
HIV and hepatitis ~10 mL
Urine pregnancy test (if appropriate) X X X
Ask about other vaccinations you have
had X X X X X X X X X
Check you meet all the study
requirements X X X
Check contraceptives (if appropriate) X X X X X X X X
Collect blood sample to test antibody
levels ~50 mL ~50 mL ~50 mL ~50 mL ~50 mL ~50 mL ~20 mL ~20 mL ~20 mL
Take a nasal swab X X
Get the study injection X X
090177e195308995\Approved\Approved On: 09-Oct-2020 16:27 (GMT)
Page 87
FDA-CBER-2021-5683-0024580
CONSENT TO TAKE PART IN STUDY
CT05 -GSOP -RF04 7.0 Phase 1/2/3/4 Clinical Study Informed Consent Template (01-Jul-2019)
TMF Doc ID: 173.13 (Study); 173.07 (Country/Central); 173.23 (Site)
Sponsor Consent Version (Study) Phase 1 09Oct ober2020
Protocol No: C4591001
CONFIDENTIAL Page:
10 of 21
For people tak ing part in Phase -1, the study doctor or nurse will :
Visit Number Screening 1 2 3 4 5 6 7 8 9 10
Visit Description Screening Study
Vaccine
1 Next -Day
Visit 1-
Week
Visit Study
Vaccine
2 1-
Week
Visit 2-
Week
Visit 1-
Month
Visit 6-
Month
Visit 12-
Month
Visit 24-
Month
Visit
Give you an e -diary or help you
download one X X
Vaccination e -diary completion for 7
days to self-report potential side
effects daily for 7 days following each
vaccination X X
Ask how you are feeling generally X X X X X X X X X X X
090177e195308995\Approved\Approved On: 09-Oct-2020 16:27 (GMT)
Page 88
FDA-CBER-2021-5683-0024581
CONSENT TO TAKE PART IN STUDY
CT05 -GSOP -RF04 7.0 Phase 1/2/3/4 Clinical Study Informed Consent Template (01-Jul-2019)
TMF Doc ID: 173.13 (Study); 173.07 (Country/Central); 173.23 (Site)
Sponsor Consent Version (Study) Phase 1 09October2020
Protocol No: C4591001
CONFIDENTIAL Page:
11 of 21
Blood samples for antibody testing
You will have blood taken up to 9 times during the planned visits of the study. This will
be used to test if you already had antibodies against the coronavirus that causes
COVID -19 when you enrolled in the study and may be used to test your antibody levels
after vaccination . About 50 mL of blood (about 10 teaspoons) would have been
collected from your arm using a needle until Visit 7, however for your remaining
planned visits 8, 9, and 10, we will collect a bout 20 mL of blood (about 4 teaspoons)
instead .
Blood samples for safety tests
At visits 2, 3, 4, and 5 , about 10 mL (about 2 teaspoons) of blood sample will be taken
to check there are no changes to your blood results after receiving the study vaccine.
E-Diary
At Visit 1, the study team will show you how to fill in an electronic diary (or e -Diary). We
will either give you a device (a bit like a mobile phone) or ask y ou to download an
application (‘app’) to your smart phone if you have one. The device/app is secure and
your confidentiality will be maintained. This device or app will allow you to complete a
vaccination e-Diary for 7 days after each vaccination, once a day in the evening with the
first day being the day of the vaccination.
You will also be given a thermometer and a measuring device to take home. You will
use the thermometer to measure your temperature under your tongue and you will use
the measuring device to measure any redness or swelling where the injection was
given. You will need to record these measurements in the vaccination e-Diary.
The vaccination e-Diary will also ask other questions about potential side effects you
may ha ve after the injection. If you have any severe symptoms after your vaccination,
you should contact your study doctor and the study doctor or nurse may schedule an
extra visit.
As well as the vaccination e -Diary, you may also have a COVID -19 illness e -Diary on
the same device or app on your smartphone. The COVID -19 illness e -Diary will prompt
you to record any COVID -19 symptoms (see below) every 7 days or at any time you
have COVID -19 symptoms. You may also receive text messages to the device or your
own smartphone, or emails (if you provide your email address) to remind you to
complete the COVID -19 illness part of the e -Diary.
It is very important that you complete the e -Diary regularly as instructed. If you do not,
your study doctor or nurse will contact you to check how you are .
090177e195308995\Approved\Approved On: 09-Oct-2020 16:27 (GMT)
Page 89
FDA-CBER-2021-5683-0024582
CONSENT TO TAKE PART IN STUDY
CT05 -GSOP -RF04 7.0 Phase 1/2/3/4 Clinical Study Informed Consent Template (01-Jul-2019)
TMF Doc ID: 173.13 (Study); 173.07 (Country/Central); 173.23 (Site)
Sponsor Consent Version (Study) Phase 1 09October2020
Protocol No: C4591001
CONFIDENTIAL Page:
12 of 21
Urine pregnancy test
If you’re a woman who is able to have children , you will have a urine pregnancy test to
check you are not pregnant before you get the study injection .
If You Get COVID -19 Symptoms
If you get any of the following you must contact the study doctor straight away .
Note that this is not instead of your routine medical care. If you feel unwell
enough that you would normally see a healthcare professional, please contact
your usual provider , as well as the study doctor .
• A diagnosis of COVID -19;
• Fever;
• New or increased cough;
• New or increased shortness of breath;
• Chills;
• New or increased muscle pain ;
• New l oss of taste/smell ;
• Sore throat ;
• Diarrhea ;
• Vomiting .
The study doctor may ask you to have a telephone conversation , video call or to visit
the site to talk about how you are feeling and if you have needed any other medical
care. They will also ask you to take a nose swab or take one from you to check for the
coronavirus (only once during each illness) . We will give you separate instructions about
how to take a nose swab yourself and how to ship the swab to the laboratory if needed .
The result from this swab and/ or from scheduled visit (s) will be provided to the study
doctor once it is available, but this will take some time, and cannot be used to diagnose
you with COVID -19 nor you should rely on these for medical treatment . This is why it is
important that you contact your usual provider i f you have COVID -19 symptoms and
think you need medical care.
If you are diagnosed with COVID -19, for the purposes of the study, the study doctor will
contact your usual provider , and any facility where you are treated , to obtain details and
collect medic al records : by signing this informed consent document, you agree to this .
090177e195308995\Approved\Approved On: 09-Oct-2020 16:27 (GMT)
Page 90
FDA-CBER-2021-5683-0024583
CONSENT TO TAKE PART IN STUDY
CT05 -GSOP -RF04 7.0 Phase 1/2/3/4 Clinical Study Informed Consent Template (01-Jul-2019)
TMF Doc ID: 173.13 (Study); 173.07 (Country/Central); 173.23 (Site)
Sponsor Consent Version (Study) Phase 1 09October2020
Protocol No: C4591001
CONFIDENTIAL Page:
13 of 21
The study doctor will arrange an extra visit to the study site about a month after you
became unwell and you will give another 20 mL (about 4 teaspoons) blood sample to
test your antibody levels.
After the study
The study vaccine is available only during this study and not after the study is over.
7. Are there any special instructions to follow for this study?
It is important you follow all the instructions given to you by the study nurse or doctor
and tell them if:
• You don’t understand anything about the study
• You are not able to comply with the study requirements
• There are changes in your health
• You take any new medications or receive any o ther vaccines
• You are going away for a long period
• You wish to take part in another research study
8. What are the possible risks and discomforts of this study?
Any research has some risks, which may include negative effects that could make you
unwell or un comfortable and even potentially be serious or life -threatening. All research
participants taking part in the study will be watched carefully for any negative effects;
however, the study team does not know all the effects that the study vaccine may have
on you.
If you take part in this study, the most likely risks or discomforts to happen to you are
discussed below.
It is important that you report to the study team all symptoms and side effects as
soon as they occur. Phone numbers for the study team are listed in [Section 1 ] of
this consent document.
Study Vaccine Risks
In early studies, these vaccines were administered to approximately 350 people (up
until August 6th 2020). In the ongoing Phase 2/3 part of the C4591001 study, 36,576
people have been enrolled (up until October 5th 2020), approximately half of whom will
have received the BNT162b2 study vaccin e and half of whom will have received
placebo. Based on these studies, the following risks have been determined to be
caused by BNT162b2 vaccine:
090177e195308995\Approved\Approved On: 09-Oct-2020 16:27 (GMT)
Page 91
FDA-CBER-2021-5683-0024584
CONSENT TO TAKE PART IN STUDY
CT05 -GSOP -RF04 7.0 Phase 1/2/3/4 Clinical Study Informed Consent Template (01-Jul-2019)
TMF Doc ID: 173.13 (Study); 173.07 (Country/Central); 173.23 (Site)
Sponsor Consent Version (Study) Phase 1 09October2020
Protocol No: C4591001
CONFIDENTIAL Page:
14 of 21
Injection site pain, fatigue (tiredness), increased body temperature (fever), chills,
headache and muscle ach es.
Other risks that commonly occur following vaccines in general include:
Injection site redness, swelling and itching; loss of appetite, joint aches and sweating.
As in all research studies, the COVID -19 vaccines may involve risks that might be
expected based on results from studies of similar vaccines, as well as risks that are
currently unknown.
As with any vaccine given by injection, people may have an allergic reaction. The
allergic reaction could be minor (rashes) or more severe (swelling of the face or lips
and/or shortness of breath). A severe allergic shock (anaphylactic shock) could occur.
Very rarely, people may have a nervous system reaction (for example, a seizure) after a
vaccine.
Therefore, it is important that you report all symptoms and side effects that you
experience as soon as they occur, whether or not you think they are caused by the
study vaccine.
Due to the way in which the study vaccines are m ade, they cannot cause COVID -19
disease.
If I catch COVID -19 disease, could the vaccine make it worse?
For some other vaccines tested in animals against similar viruses (but not the
coronavirus that causes COVID -19), there have been reports of the illness being more
severe in the animals that received the vaccine than in those that did not. So far this has
not been seen with COVID -19 vaccines, but at the moment we do not know whether the
study vaccines could make a later COVID -19 illness more severe. That i s one of the
reasons why you are asked to contact your study doctor if you develop symptoms that
might be caused by COVID -19 (for example, fever, cough, shortness of breath).
Placebo Risks
As the placebo injection contain s salt -water and no active ingredi ents, the chances of
having the side effects mentioned above are less likely. In other studies using the same
placebo , some people who received the placebo injection reported pain, bruising,
swelling and redness at the site of injection.
Risks from Study Procedures
090177e195308995\Approved\Approved On: 09-Oct-2020 16:27 (GMT)
Page 92
FDA-CBER-2021-5683-0024585
CONSENT TO TAKE PART IN STUDY
CT05 -GSOP -RF04 7.0 Phase 1/2/3/4 Clinical Study Informed Consent Template (01-Jul-2019)
TMF Doc ID: 173.13 (Study); 173.07 (Country/Central); 173.23 (Site)
Sponsor Consent Version (Study) Phase 1 09October2020
Protocol No: C4591001
CONFIDENTIAL Page:
15 of 21
Risks and possible discomforts you might have from the study procedures include:
• Blood samples: The risks and possible discomforts involved in taking blood
include pain from inserting the needle, or less often, swelling, bruising, or
infection around the vein where the blood is collected. You may feel dizzy or
may faint. If you have a previous history of feeling dizzy or fainting during blood
sample collection, you should talk to the study doctor.
• Nasal S wabs : The risks and possible discomforts invo lved in takin g nasal swabs
may include pain or general discomfort. Sometimes it may cause the nose to
bleed.
Pregnancy -Related Risks; Use of Birth Control
If you are currently pregnant, plan to become pregnant, or are breastfeeding a child, you
should not join this study.
If you are able to have children and you are sexually active, you must use birth control
consistently and correctly for at least 28 days after you receive your last injection . This
applies to men as well as women who take part in the research study. The study doctor
will discuss with you the methods of birth control that you should use while you are in
this research study and will help you select the method(s) that is approp riate for you.
The study doctor will also check that you understand how to use the birth control
method and may review this with you at each of your research study visits.
Birth control methods, even when used properly are not perfect. If you or your partner
becomes pregnant during the research study, or you want to stop your required birth
control during the research study, you should tell the study doctor immediately . You
may b e withdrawn from the research study if you stop using birth control or yo u become
pregnant.
Pregnancy Follow -up
If you or your partner become pregnant during the study, up until 6 months after you last
study injection , please tell the study doctor immediately . Please also tell the doctor who
will be taking care of you/your par tner during the pregnancy that you took part in this
study. The study doctor will ask if you/your partner or your pregnancy doctor is willing to
provide updates on the progress of the pregnancy and its outcome. If you/your partner
agree, this information w ill be provided to BioNTech/ Pfizer for safety follow -up.
9. What are possible benefits of this study?
090177e195308995\Approved\Approved On: 09-Oct-2020 16:27 (GMT)
Page 93
FDA-CBER-2021-5683-0024586
CONSENT TO TAKE PART IN STUDY
CT05 -GSOP -RF04 7.0 Phase 1/2/3/4 Clinical Study Informed Consent Template (01-Jul-2019)
TMF Doc ID: 173.13 (Study); 173.07 (Country/Central); 173.23 (Site)
Sponsor Consent Version (Study) Phase 1 09October2020
Protocol No: C4591001
CONFIDENTIAL Page:
16 of 21
It is not known yet whether the study vaccines may reduce the chance of you getting
COVID -19, so you may not directly benefit from participating in the study. For this
reason, you should still follow local recommendations about how to avoid COVID -19.
Information learned from the research study may help other people in the future
10. What will happen to my blood and nasal swab samples?
Your blood and nasal swab samples will be used only for scientific research. Each
sample will be labeled with a code so that the laboratory workers testing the samples
will not know who you are. Some of the samples may be stored for future testing and
may be kept for up to 15 ye ars after the study ends, at which time they will be
destroyed. In addition to testing for this study, any samples left over after the study is
complete may be used for additional research related to the development of products.
No testing of your DNA will be performed.
You may request that your samples, if they can be identified, be destroyed at any time.
Any data already collected from those samples will still be used for the study. The
samples will remain the property of BioNTech/ Pfizer and may be share d with other
researchers as long as confidentiality is maintained and no testing of your DNA will be
performed. You will not be told of additional tests, nor will you receive results of any of
these tests.
11. What other choices do I have if I do not join thi s study?
This study is for research purposes only. Your alternative is to not take part in this
study .
12. What happens if I am injured during this study?
For mandatory research injury language, < click here > (retain this link in the study -level
ICD). The country -specific research injury language must be included verbatim in the
country -level ICD .
13. What if I join this study and then change my mind?
If you agree to participate and then change your mind for any reason, you are free to
stop participating at any time. Your decision will not affect your regular medical care or
any benefits to which you are entitled. Tell the study doctor if you are thinking about
stopping or decide to stop so that you can end participation in the study in the safest
way.
While you are participating, the study team will tell you in a timely manner if new
information is learned during the course of the study that could change your mind about
090177e195308995\Approved\Approved On: 09-Oct-2020 16:27 (GMT)
Page 94
FDA-CBER-2021-5683-0024587
CONSENT TO TAKE PART IN STUDY
CT05 -GSOP -RF04 7.0 Phase 1/2/3/4 Clinical Study Informed Consent Template (01-Jul-2019)
TMF Doc ID: 173.13 (Study); 173.07 (Country/Central); 173.23 (Site)
Sponsor Consent Version (Study) Phase 1 09October2020
Protocol No: C4591001
CONFIDENTIAL Page:
17 of 21
continuing in this study. If you decide to withdraw from the study, you may be asked to
continue to participate in the study procedures even though you would no longer receive
the study vaccine.
If you agree to continue with the study, information about your health will continue to be
collected as described in [Section 6].
If you decide to stop participating in this study, you must notify the study doctor. The
study team will explain what other procedures or discussions would occur.
Sometimes the study doctor or BioNTech/ Pfizer may decide to take you out of the study
(even if you do not agree ) if:
• You are unable or unwilling to follow the instructions of the study team;
• The study doctor decides that the study is not in your best interest or that you are no
longer eligible t o participate; or
• The study is stopped by BioNTech/Pfizer , the institutional review board (IRB) or
independent ethics committee (IEC) (a group of people who review the study to
protect your rights), or by a government or regulatory agency .
The study team will give you a Privacy Supplement, which is considered part of this
consent document. It describes what happens to your personal information (including
your biological samples) and how it may be used if you withdraw from the study.
14. What will I have to pay for if I take part in this study?
You will not need to pay for any of the study vaccines (COVID -19 Vaccine or placebo),
study -related procedures, or study visits.
15. Will I be paid for taking part in this study?
You will not receive any payment for taking part in this study. However, for each visit
you complete, you will be reimbursed by the study site to cover reasonable expenses
(for example, parking, meals, travel) that you have as a result of taking part in t his
study. You will be reimbursed by [enter, as applicable, method of reimbursement;
amounts; and reimbursement schedule; note whether receipts are required].
BioNTech/Pfizer may use information resulting from the study to develop products or
processes fro m which they may make a profit. There are no plans to pay you or provide
you with any products developed from this research. BioNTech/Pfizer will own all
products or processes that are developed using information from the study.
16. What will happen to my personal information?
090177e195308995\Approved\Approved On: 09-Oct-2020 16:27 (GMT)
Page 95
FDA-CBER-2021-5683-0024588
CONSENT TO TAKE PART IN STUDY
CT05 -GSOP -RF04 7.0 Phase 1/2/3/4 Clinical Study Informed Consent Template (01-Jul-2019)
TMF Doc ID: 173.13 (Study); 173.07 (Country/Central); 173.23 (Site)
Sponsor Consent Version (Study) Phase 1 09October2020
Protocol No: C4591001
CONFIDENTIAL Page:
18 of 21
<click here > for language to be inserted into this section. This text must be inserted
verbatim. Any requested changes must be approved by Clinical Development Legal. Note
that the Privacy Supplement follows this consent document, after the signature section.
17. Where can I find additional information about this study or the
study res ults?
A description of this clinical trial will be available on http://www.ClinicalTrials.gov , as
required by U.S. Law. This Web site will not include information that can identify you. At
most, the Web site wi ll include a summary of the results. You can search this Web site
at any time.
The study results, when available, may also be found on www.pfizer.com and
https://www.clinicaltrialsregister.eu/ .
In addition, a plain summary of the study results will be made available in the EU database
at [insert link to the database ]. This information will be provided no matter what the study’s
outcome. To the extent possib le, you will be able to access these summaries in the EU
database soon after they become available using the following EU trial number for the
study: [ insert trial number ].
These Web sites are in English only. If you need assistance understanding these Web
sites, please ask a member of the study team.
BioNTech/Pfizer will provide the study doctor with information about the study results
when all participants have completed the study. At that ti me, certain of your individual
study results may be given to you or your doctor (if different from the study doctor) in
accordance with applicable law , but will not be given to your family, your employer or
any insurance company .
If any exploratory research is done, it may not be possible to link any results from that
exploratory research to specific individuals, including you. BioNTech/Pfizer does not
plan to return information from any exploratory research to you, the study docto r, or
your doctor (if different from the study doctor).
18. Signatures
Agreement to Participate and to Process Data
1. I confirm I have read (or, if I cannot read, a study team member has read to me)
and understand this consent document for the study described above and have
090177e195308995\Approved\Approved On: 09-Oct-2020 16:27 (GMT)
Page 96
FDA-CBER-2021-5683-0024589
CONSENT TO TAKE PART IN STUDY
CT05 -GSOP -RF04 7.0 Phase 1/2/3/4 Clinical Study Informed Consent Template (01-Jul-2019)
TMF Doc ID: 173.13 (Study); 173.07 (Country/Central); 173.23 (Site)
Sponsor Consent Version (Study) Phase 1 09October2020
Protocol No: C4591001
CONFIDENTIAL Page:
19 of 21
had the opportunity to ask questions. I have had enough time to review this
consent document. I also have had an opportunity to ask about the details of the
study and to decide whether or not to participate.
2. I have read and understand the Privacy Supplement. I understand that taking part
in the study will require the processing (including collection, use, transfer, storage,
analysis and reporting) of my personal information, as explained in the Privacy
Supplement. I understand and agree to the processing of my personal information
within and outside my country of residence for health care, medical research
and/or regulatory purposes.
3. I understand that taking part is voluntary and that I am free to stop taking part in
this study or to withdraw my consent to the processing of my personal information
at any time. I do not need to give any reason and my regular medical care and
legal rights will not be affected. However, even if I withdraw my consent to
processing, my personal information held at that time may be kept to comply with
laws and regulations and to maintain the integrity of the study. I also understand
that my biological samples may not be able to be destroyed because they may no
longer be tracea ble to me, may have already been used, or may have been given
to a third party.
4. I agree to the study team accessing my medical history, including information from
medical records and test results and any medical treatment I receive during the
course o f the study, and if necessary, contacting my doctor or any other health
care providers treating me for access to such information.
5. I understand that BioNTech/Pfizer and/or others working with or on behalf of
BioNTech/Pfizer , institutional review board s (IRBs) or independent ethics
committees (IECs) , and regulatory agencies may need access to personal
information about me generated at the study site or collected by the study team for
the study and any other research. I agree that they may have access to my
personal information.
6. I do not give up any of my legal rights by signing this consent document. I have
been told that I will receive a signed and dated copy of this document.
7. I agree to take part in the study described in this document.
_________________________________________
Printed name of participant
090177e195308995\Approved\Approved On: 09-Oct-2020 16:27 (GMT)
Page 97
FDA-CBER-2021-5683-0024590
CONSENT TO TAKE PART IN STUDY
CT05 -GSOP -RF04 7.0 Phase 1/2/3/4 Clinical Study Informed Consent Template (01-Jul-2019)
TMF Doc ID: 173.13 (Study); 173.07 (Country/Central); 173.23 (Site)
Sponsor Consent Version (Study) Phase 1 09October2020
Protocol No: C4591001
CONFIDENTIAL Page:
20 of 21
________________________________________________ ______________
Signature of participant Date of signature§
(If no legally acceptable representative is used)
§Participant must personally date their signature.
Person Obtaining Consent:
____________________________________
Printed Name of the Person Conducting the
Consent Discussion
________________________________________ _______________
Signature of the Person Conducting the Date of signature
Consent Discussion †
†The investigator, or an appropriately qualified and trained person designated by the
investigator to conduct the informed consent process, must sign and date the consent
document during the same discussion when the participant signs the consent
document .
090177e195308995\Approved\Approved On: 09-Oct-2020 16:27 (GMT)
Page 98
FDA-CBER-2021-5683-0024591
PRIVACY SUPPLEMENT
CT05 -GSOP -RF04 7.0 Phase 1/2/3/4 Clinical Study Informed Consent Template (01-Jul-2019)
TMF Doc ID: 173.13 (Study); 173.07 (Country/Central); 173.23 (Site)
Consent Version (Study) Phase 1 0 9September2020
Protocol No: C4591001
CONFIDENTIAL Page:
21 of 21
PRIVACY SUPPLEMENT
For mandatory country -specific data privacy language to be inserted in this Privacy
Supplement, <click here > (retain this link in the study -level ICD). The country -specific
data privacy language must be included verbatim in the country -level ICD. Any requested
changes must be approved by Clinical Development Legal.
Who will use my personal information, how will they use it, and where will it be
stored?
[Mandatory study language – retain the below paragraph and delete this green text before
the finalisation ]
Any personal information collected about you during this study will be entered into
records, including health records, maintained by the study team at your study site. Your
records that include information that directly identifies you may be uploaded to se cure
systems maintained by a third party engaged by BioNTech/ Pfizer so that BioNTech/ Pfizer
and/or BioNTech/ Pfizer representatives can review and verify study data. Some of the
uploaded records will be kept for XX years. The remaining records that are uploaded will
be temporary and removed from the secure system after the study is over.
090177e195308995\Approved\Approved On: 09-Oct-2020 16:27 (GMT)
Page 99
FDA-CBER-2021-5683-0024592
Document index: A-1426-0082-5150UG
Document version: 4
Template version: 12
01JUN2020
C4591001
TrialMax App™, TrialManager®
Site User Guide
090177e195690443\A pproved\A pproved On: 02-Nov-2020 14:16 (GMT )
Page 100
FDA-CBER-2021-5683-0024593
2 / 81
Copyright Notice
© 2020 Signant Health
Trademark Notice
CRF Health®, C-R-F (& Design)®, C-R-F Health (& Design)®, iPrompt (& design)®,
TRIALMax Connected … for life (& Design), TrialMax®, TrialIntegrator®,
TrialCollector®, TrialManager®, TrialStudio® and TrialLibrary® C-R-F Health (&
Design) ®, C-R-F Health Real Patient Data 24/7 (& Design)®, TrialMax Touch®,
TrialMax Slate (& Design)®, TrialMax Web (&Design) ®, are regis tered
trademarks of CRF Inc.
TrialMax Synapse (&Design) ™, TrialMax App (&Design) ™ are trad emarks
and/or service marks of CRF Inc. All other trademarks and/or service marks are the property of t heir respective
owners.
090177e195690443\A pproved\A pproved On: 02-Nov-2020 14:16 (GMT )
Page 101
FDA-CBER-2021-5683-0024594
3 / 81 IMPORTANT POINTS
Keep devices charged at all times – when stored at site, please
ensure the device(s) are charged at least once per week, even i f
not in use. If the device battery runs flat, it might have an
incorrect date and time when it is turned back on again. If thi s
happens, send data from the device and it will sync to your current time zone.
Data will send automatically each time the participant logs int o
the App as long as the device is charged, in an area where ther e is
mobile phone service or Wi-Fi is available.
Participants should bring their assigned device with the App to
each clinic visit.
Participant setup should occur on the day of vaccination, whilst
the participant is at the study clinic.
Each participant will be able to set their own PIN code when th ey
first log in to the TrialMax device. Please recommend to them t o
select the same code for each de vice as it will be easier for t hem
to remember.
When setting up a participant for the study, make sure this is
done on a computer with a printer, as you will need to print th e
activation information for the participant. You will only have the
opportunity to print this once; however, it will also be emaile d to
the participant if their email address is provided during setup or
sent via a text message if a mo bile phone number is provided
during setup.
To receive SMS notifications in the US, please refer to ‘Setting up
SMS notifications’ section for more details.
Use the TrialManager web portal to regularly monitor participant
data for the study. 090177e195690443\A pproved\A pproved On: 02-Nov-2020 14:16 (GMT )
Page 102
FDA-CBER-2021-5683-0024595
4 / 81 It is recommended to leave 0.5GB of free storage space on the
participant’s personal device to allow the TrialMax app to func tion
properly. Please provide a provisioned device to the participan t in
the event the participant does not have the free space or does not
want to make that space available. The participant may check their available storage below:
oiPhone: Select ‘Settings’->’General’->’iPhone Storage’
oAndroid: Select ‘Settings’ ->’Device Care’->’Storage’
If you cannot find help in this guide, then please call the Hel pdesk.
Role PIN Code
Default Participant 1234
Logistics Access PIN Code 8888
Logistics PIN Code 4422
TrialManager Website URL
http://trialmax.crfhealth.net/c4591001
TrialManager login details will be sent to you via email090177e195690443\A pproved\A pproved On: 02-Nov-2020 14:16 (GMT )
Page 103
FDA-CBER-2021-5683-0024596
5 / 81 Table of Contents
TrialManager Website URL ................................................................ 4
1 Signant Health Overview ..................................... ....................... 9
2 Helpdesk..................................................... ............................. 10
2.1 Helpdesk Operating Hours ............................................... 10
2.2 Helpdesk Telephone Numbers................................. ......... 10
2.3 Helpdesk Email Address .................................... ............... 11
Helpdesk Web Chat via TrialManager ............................ .............. 11
Providing feedback about Helpdesk performance ................. ....... 15
3 Equipment ................................................... ............................ 17
3.1 Supplies for participant .................................................... 17 3.2 Provisioned Device Basics ................................. ................ 17
3.3 How to turn on the Provisioned device ..................... ........ 18
3.4 How to charge the Provisioned Device ...................... ....... 18
3.5 Device Navigation ......................................... ................... 19
3.6 Additional Site Supplies .................................. .................. 19
4 TrialManager ................................................ ........................... 20
4.1 Functions of TrialManager ................................................ 20
4.2 Accessing the TrialManager website ........................ ......... 21
4.2.1 How to change your TrialManager password ............ 22
4.2.2 How to Reset your TrialManager Password............... 23
4.2.3 How to request TrialManager access for new team
members 25 090177e195690443\A pproved\A pproved On: 02-Nov-2020 14:16 (GMT )
Page 104
FDA-CBER-2021-5683-0024597
6 / 81 4.3 How to navigate the TrialManager website .................. .... 25
4.3.1 Main Page Tab ........................................... ............... 26
4.4 Add a new participant ...................................................... 28
4.4.1 Participant Details Card ................................ ............ 28
4.4.2 Data Item Audit Trails .................................. ............. 29
4.5 Reports Tab ............................................... ....................... 31
4.6 How To Review Reports ..................................... .............. 32
4.6.1 Reports User Guide ...................................... ............ 33
4.6.2 Hints and Tips for Viewing Reports ...................... ..... 34
4.7 C4591001 Custom reports ................................................ 38
4.7.1 Daily Diary Data Summary Report ......................... .... 38
4.7.2 Severe Reactions Requ iring Contact Report .............. 39
4.7.3 Daily Diary Compliance Report ........................... ...... 40
4.7.4 Symptoms Dashboard Report ............................... .... 41
4.7.5 Missed Day 7 Transfer Report ............................ ....... 42
5 DATA CLARIFICATION FORM (DCF) ............................... ............ 43
5.1 What is a DCF ............................................. ...................... 43
5.2 Types of data changes allowed: ............................ ............ 43
5.3 Where to create DCF s in Trial Manager ...................... ....... 44
5.4 How to create a DCF ....................................... .................. 44
5.5 Approval of DCFs .............................................................. 49
When to approve DCFs .......................................... .................. 49
How to Approve DCFs ........................................... ................... 49
5.6 Adding Additional Information to DCFs ..................... ....... 52
How to Answer Comments: Waiting for Information ............... . 52
How to Modify DCFs ................................................................ 54 090177e195690443\A pproved\A pproved On: 02-Nov-2020 14:16 (GMT )
Page 105
FDA-CBER-2021-5683-0024598
7 / 81 How to Cancel/Deny DCFs........................................ ................ 54
5.7 Viewing DCF Comment and Action History .................... ... 55
5.8 DCF Timelines and Tips for Success......................... .......... 57
DCF Timelines ................................................. ......................... 57
Tips for Success........................................................................ 57
6 Setting up SMS notifications ................................ .................... 58
7 How to set up a participant in TrialManager ................. ........... 59
7.1 How to Activate the App ................................... ............... 62
7.1.1 How to setup WiFi on the Provisioned Device ........... 6 3
7.1.2 Instructions for reusing the Provisioned Device ........ 63
7.2 Selecting a TrialMax App PIN .............................. .............. 66
7.3 Logging In & Setting Security Question .................... ......... 67
7.4 Training on the TrialMax App .............................. ............. 68
7.5 Software Updates ............................................................ 69
8 Managing Participants in TrialManager ....................... ............. 69
8.1 Participant Card .......................................... ..................... 69
8.2 Activating a new App for an Existing Participant .......... ..... 70
8.3 Management tab ............................................ ................. 72
8.3.1 Activating a New Vaccination............................. ....... 73
8.3.2 Changing Daily Diary Reminder Time ...................... .. 74
8.4 Deactivating a Participant from the Study ................. ....... 75
8.5 Participant Travel ........................................ ..................... 76
9 How to Request Additional Supplies .......................... .............. 77
10 How to return the provisioned devices ...................... .............. 77 090177e195690443\A pproved\A pproved On: 02-Nov-2020 14:16 (GMT )
Page 106
FDA-CBER-2021-5683-0024599
8 / 81 11 Frequently Asked Questions ................................. ................... 78
12 APPENDIX A: US LOGISTICS DEVICE RETURNS .................... ....... 81
090177e195690443\A pproved\A pproved On: 02-Nov-2020 14:16 (GMT )
Page 107
FDA-CBER-2021-5683-0024600
9 / 81 1 Signant Health Overview
Signant Health is the provider of the eCOA (electronic Clinical
Outcome Assessment) system for this study. The eCOA system
comprises the components as displayed below, along with 24/7 Helpdesk support. TrialMax App is the brand name, but we will r efer
to it simply as the “App”.
Data entered by
Participant into
the App Data sent from
App to Signant
Health servers Data available for sites,
monitors and study t eam
in web portal and
TrialManager
090177e195690443\A pproved\A pproved On: 02-Nov-2020 14:16 (GMT )
Page 108
FDA-CBER-2021-5683-0024601
10 / 81 2 Helpdesk
You may call the Helpdesk for any issue related to the TrialMax App,
or TrialManager website.
Please have the following information ready when you call:
xThe study protocol number: C4591001
xHelpdesk Priority PIN: 19
xSignant Health project code: A-1426-0082
xYour site number
xThe participant number (if applicable)
xThe specific problem
2.1 Helpdesk Operating Hours
The Helpdesk is available 24 hours a day, 365 days a year. If you are unable to reach an agent when you call, you can also leave a
voicemail or send an email giving your contact information. The
Helpdesk will contact you as soon as possible, at the latest by n e x t
business day.
2.2 Helpdesk Telephone Numbers
Country Number
USA (1) 866 402 1154
Helpdesk Priority Code 19
Note : Toll Free numbers are free from a landline; however local
operator charges might be applied if calling from a mobile phon e.
090177e195690443\A pproved\A pproved On: 02-Nov-2020 14:16 (GMT )
Page 109
FDA-CBER-2021-5683-0024602
11 / 81 2.3 Helpdesk Email Address
For non-urgent issues, you can contact the Helpdesk by email:
C4591001_TM@s upport.signanthealth.com
Note: Do not share this email address with participant. The
participant’s identity might be unintentionally revealed during
communication via email.
Helpdesk Web Chat via TrialManager
The Helpdesk Web-chat is available via the TrialManager Portal.
Helpdesk Web-chat can be accessed via the steps below:
1) Please click the Help Desk button in the upper right corner o f your
screen.
2) You will see a welcome page where all the texts highlighted i n red
will be pre-filled.
090177e195690443\A pproved\A pproved On: 02-Nov-2020 14:16 (GMT )
Page 110
FDA-CBER-2021-5683-0024603
12 / 81
3) You can open the web-chat, available in 60+ languages, by cli cking
the blue widget in the lower left corner of the screen to start your
live chat with one of our Support Agents.
090177e195690443\A pproved\A pproved On: 02-Nov-2020 14:16 (GMT )
Page 111
FDA-CBER-2021-5683-0024604
13 / 81 4) Once you click on this widget, you will be able to select you r
preferred language from the drop-down menu.
090177e195690443\A pproved\A pproved On: 02-Nov-2020 14:16 (GMT )
Page 112
FDA-CBER-2021-5683-0024605
14 / 81 5) After selecting your language, you will need to complete the
necessary information in the below screen and click the Continu e
button, then you will be connected to the next available suppor t
agent.
Fields with an asterisk (*) are required.
Once you click on “Continue”, you will be connected to the Sign ant
Health Helpdesk specialist, who will discuss your issue with yo u.
Please note that if a telephone call has already been placed ma ke sure
that you enter the Ticket Number you received from your telepho ne
call into the web chat the ensure the background information is linked.
If the ticket number is not entered, it will be counted as 2 se parate
calls.
Your First name
Your Last name
Your email address Type in Signant Health
Study Code (A-1426-
0082)
Type in your Site number
Participant Number (if applicable)
Device ID
Ticket Number (if you
already have one)
090177e195690443\A pproved\A pproved On: 02-Nov-2020 14:16 (GMT )
Page 113
FDA-CBER-2021-5683-0024606
15 / 81 Providing feedback about Helpdesk performance
Each time you request support from the Helpdesk, you can rate t he
level of your satisfaction from the provided service. This is i mportant,
as it helps us continuously improve to exceed your expectations .
You can provide the feedback in 2 ways:
xEach time you have spoken to the Helpdesk on the phone
you can remain on the line and rate your experience on the
scale 0 to 5, where 5 is awesome and 0 poor.
xWhen your request has been completed, you will receive an
email, enabling you
…[truncated]