Document text
16.2.1.1.1 Listing of Subjects Discontinued From Vaccination and/or From the Study –
Subjects 12 Through 25 Years of Ag e
Age
Group
(Years) Subject Dose
No. Rel
Daya Withdrawal
Date Study Phase Withdrawal Reason Commentb
12-15 C4591001
1006
10061272 1 22 06JAN2021 VACCINATION ADVERSE EVENT ADVERSE EVENT/ANXIETY
1 22 06JAN2021 VACCINATION ADVERSE EVENT ADVERSE EVENT/DEPRESSION
C4591001
1007
10071409 1 10 31OCT2020 VACCINATION NO LONGER MEETS
ELIGIBILITY CRITERIA exclusion #5 meet
C4591001
1007
10071593 1 24 20JAN2021 VACCINATION PROTOCOL DEVIATION receipt of non -study COVID vaccine prior to study
end
1 47 12FEB2021 FOLLOW -UP PROTOCOL DEVIATION Receipt of non -study COVID vaccine prior to study
end
C4591001
1007
10071622 1 22 20JAN2021 VACCINATION OTHER Participant had COVID -19 prior to second vaccine
C4591001
1007
10071642 1 22 25JAN2021 VACCINATION NO LONGER MEETS
ELIGIBILITY CRITERIA clinical or microbiological diagnosis of COVID -19
C4591001
1008
10081871 1 49 16FEB2021 VACCINATION NO LONGER MEETS
ELIGIBILITY CRITERIA subject tested positive for COVID 19
C4591001
1008
10081884 1 50 18FEB2021 VACCINATION NO LONGER MEETS
ELIGIBILITY CRITERIA subject tested positive for COVID 19
C4591001
1008
10081901 2 18 12FEB2021 VACCINATION OTHER the participant is willing/eligible to receive
Vaccination 3
C4591001
1009
10091229 1 21 09NOV2020 VACCINATION NO LONGER MEETS
ELIGIBILITY CRITERIA Covid positive between visit one and visit 2,
exclusion #5
090177e196ac9156\Final\Final On: 31-Mar-2021 13:05 (GMT)
Page 1
FDA-CBER-2022-5812-0223777
16.2.1.1.1 Listing of Subjects Discontinued From Vaccination and/or From the Study –
Subjects 12 Through 25 Years of Ag e
Age
Group
(Years) Subject Dose
No. Rel
Daya Withdrawal
Date Study Phase Withdrawal Reason Commentb
C4591001
1009
10091338 1 19 01JAN2021 VACCINATION NO LONGER MEETS
ELIGIBILITY CRITERIA exclusion #5
C4591001
1009
10091363 1 11 27DEC2020 VACC INATION NO LONGER MEETS
ELIGIBILITY CRITERIA has tested positive for COVID -19
C4591001
1016
10161316 1 17 01NOV2020 VACCINATION NO LONGER MEETS
ELIGIBILITY CRITERIA subject with positive covid -19
C4591001
1016
10161379 1 30 05FEB2021 VACCINATION NO LONGER MEETS
ELIGIBILITY CRITERIA subject with positive covid test
C4591001
1044
10441344 2 11 08FEB2021 VACCINATION OTHER transitioning to open label
C4591001
1057
10571413
21DEC2020 VACCINATION NO LONGER MEETS
ELIGIBILITY CRITERIA DELAY CRITERIA MET
21DEC2020 FOLLOW -UP NO LONGER MEETS
ELIGIBILITY CRITERIA DELAY CRITERIA MET
C4591001
1057
10571420 2 45 24FEB2021 VACCINATION WITHDRAWAL BY
PARENT/GUARDIAN mother stated she didn't want him to do it anymore
2 45 24FEB2021 FOLLOW -UP WITHDRAWAL BY
PARENT/GUARDIAN mother stated she didn't want him to do it anymore
C4591001
1066
10661428 2 17 11FEB2021 VACCINATION OTHER subject unblinded for vax 3 per pro tocol
C4591001
1077
10771293
18DEC2020 SCREENING OTHER SUBJECT WAS RANDOMIZED THE
SUBSEQUENTLY UNABLE TO TOLERATE
BLOOD DRAW.
090177e196ac9156\Final\Final On: 31-Mar-2021 13:05 (GMT)
Page 2
FDA-CBER-2022-5812-0223778
16.2.1.1.1 Listing of Subjects Discontinued From Vaccination and/or From the Study –
Subjects 12 Through 25 Years of Ag e
Age
Group
(Years) Subject Dose
No. Rel
Daya Withdrawal
Date Study Phase Withdrawal Reason Commentb
18DEC2020 VACCINATION REFUSED FURTHER
STUDY PROCEDURES REFUSED FURTHER STUDY PROCEDURES
C4591001
1091
10911414 1 14 22DEC2020 VACCINATION NO LONGER MEETS
ELIGIBILITY CRITERIA Tested positive for Covid (exclusion 5)
C4591001
1091
10911451
04JAN2021 FOLLOW -UP OTHER Subject was rescreened under #1462. Subject
randomized in error.
C4591001
1126
11261287 1 15 30DEC2020 VACCINATION NO LONGER MEETS
ELIGIBILITY CRITERIA Subject did not receive 2nd vaccine due to Covid 19
disease.
C4591001
1139
11391235 2 19 15FEB2021 VACCINATION OTHER Crossed over to Visit 101
C4591001
1139
11391263 2 19 19FEB2021 VACCINATION OTHER Crossed -over
C4591001
1140
11401346
22DEC2020 SCREENING OTHER DISCONTINUED
22DEC2020 FOLLOW -UP NO LONGER MEETS
ELIGIBILITY CRITERIA SUBJECT TO BE DISCONTINUED DUE TO
UNABLE TO OBTAIN SPECIMEN
C4591001
1147
11471327 1 4 08JAN2021 VACCINATION ADVERSE EVENT ADVERSE EVENT/PYREXIA
C4591001
1156
11561316 2 73 10MAR2021 VACCINATION PROTOCOL DEVIATION SUBJECT CAN NOT BE REACHED VIA PHONE.
CERTIFIED LETTER SENT. SUBJECT
CONTINUES TO COMPLETE eDIARY.
C4591001
1156
11561320 2 34 25JAN2021 VACCINATION WITHDRAWAL BY
SUBJECT SUBJECT AND FATHER STATED THAT THEY
NO LONGER WISHED TO PARTICIPATE IN THE
TRIAL.
090177e196ac9156\Final\Final On: 31-Mar-2021 13:05 (GMT)
Page 3
FDA-CBER-2022-5812-0223779
16.2.1.1.1 Listing of Subjects Discontinued From Vaccination and/or From the Study –
Subjects 12 Through 25 Years of Ag e
Age
Group
(Years) Subject Dose
No. Rel
Daya Withdrawal
Date Study Phase Withdrawal Reason Commentb
C4591001
1270
12701237 1 20 26JAN2021 VACCINATION NO LONGER MEETS
ELIGIBILITY CRITERIA EC#55: Participant had a positive local COVID -19
test before Vx2, symptomatic with t est
16-25 C4591001
1001
10011125 1 37 09SEP2020 VACCINATION WITHDRAWAL BY
SUBJECT Withdrew consent and decided not to continue in
study.
1 37 09SEP2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT patient withdrew consent
C4591001
1005
10051238 2 65 06JAN2021 FOLLOW -UP WITHDRAWAL BY
SUBJECT SUBJECT WAS UNBLINDED AND FOUND OUT
HE RECEIVED PLACEBO. HE DECIDED TO
WITHDRAW
C4591001
1005
10051341 1 2 22OCT2020 VACCINATION NO LONGER MEETS
ELIGIBILITY CRITERIA subject tested CO VID positive between visits 1 and 2
C4591001
1006
10061174 2 113 22FEB2021 FOLLOW -UP WITHDRAWAL BY
SUBJECT Inclusion 2
C4591001
1007
10071556 2 29 26JAN2021 VACCINATION NO LONGER MEETS
ELIGIBILITY CRITERIA Exclusion #12; received COVID vaccine outside of
study
2 29 26JAN2021 FOLLOW -UP PROTOCOL DEVIATION Receipt of non -study COVID vaccine prior to study
end
C4591001
1008
10081480 2 115 04FEB2021 FOLLOW -UP LOST TO FOLLOW -UP site unable to make contact with subject despite
numerous attempts
C4591001
1009
10091235 2 107 25FEB2021 REPEAT
SCREENING 1 OTHER Visit 101 delayed due to recent vaccination
C4591001
1009
10091257 1 10 05NOV2020 VACCINATION NO LONGER MEETS
ELIGIBILITY CRITERIA positive for COVID -19
090177e196ac9156\Final\Final On: 31-Mar-2021 13:05 (GMT)
Page 4
FDA-CBER-2022-5812-0223780
16.2.1.1.1 Listing of Subjects Discontinued From Vaccination and/or From the Study –
Subjects 12 Through 25 Years of Ag e
Age
Group
(Years) Subject Dose
No. Rel
Daya Withdrawal
Date Study Phase Withdrawal Reason Commentb
C4591001
1009
10091286 2 13 04JAN2021 VACCINATION OTHER subject transitioned to open prior to visit 3
C4591001
1013
10131395 2 45 04NOV2020 VACCINATION LOST TO FOLLOW -UP ATTEMPTED TO CONTACT.
2 45 04NOV2020 FOLLOW -UP LOST TO FOLLOW -UP UNABLE TO CONTACT SUBJECT AFTER
MULTIPLE ATTEMPTS.
C4591001
1013
10131592 2 31 11NOV2020 VACCINATION WITHDRAWAL BY
SUBJECT subject withdrew consent from study.
2 31 11NOV2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT MOVED OUT OF STATE NO LONGER WANTED
TO PARTICIPATE.
C4591001
1013
10131683 2 129 10MAR2021 FOLLOW -UP WITHDRAWAL BY
SUBJECT SUBJECT DID NOT WISH TO CONTINUE IN
STUDY.
C4591001
1013
10131740
15OCT2020 FOLLOW -UP OTHER randomized in error, needed to wait until course of
antibiotics was done.
C4591001
1016
10161348 1 10 14NOV2020 VACCINATION NO LONGER MEETS
ELIGIBILITY CRITERIA subject had positive pcr covid test
C4591001
1018
10181054 1 39 11SEP2020 VACCINATION LOST TO FOLLOW -UP patient returned to home country, did not respond to
outreach, certified letter sent
1 39 11SEP2020 FOLLOW -UP LOST TO FOLLOW -UP subject returned to home country, according to call to
emergency contact
C4591001
1018
10181335 2 104 24FEB2021 VACCINATION PHYSICIAN DECISION PHYSICIAN DECISION
090177e196ac9156\Final\Final On: 31-Mar-2021 13:05 (GMT)
Page 5
FDA-CBER-2022-5812-0223781
16.2.1.1.1 Listing of Subjects Discontinued From Vaccination and/or From the Study –
Subjects 12 Through 25 Years of Ag e
Age
Group
(Years) Subject Dose
No. Rel
Daya Withdrawal
Date Study Phase Withdrawal Reason Commentb
2 104 24FEB2021 FOLLOW -UP PHYSICIAN DECISION PHYSICIAN DECISION
C4591001
1028
10281294 1 7 04NOV2020 VACCINATION NO LONGER MEETS
ELIGIBILITY CRITERIA patient had positive covid test prior to V2
C4591001
1036
10361011 1 1 20AUG2020 VACCINATION LOST TO FOLLOW -UP Lost to follow up
1 1 20AUG2020 FOLLOW -UP LOST TO FOLLOW -UP Lost to follow up
C4591001
1036
10361032 2 48 03NOV2020 VACCINATION LOST TO FOLLOW -UP unreachable
2 48 03NOV2020 FOLLOW -UP LOST TO FOLLOW -UP unreachable
C4591001
1036
10361061 2 155 22FEB2021 FOLLOW -UP LOST TO FOLLOW -UP Lost to follow -up
C4591001
1036
10361062 2 136 03FEB2021 FOLLOW -UP LOST TO FOLLOW -UP Subject didn't return for Convalescent visit &
multiple attempts to contact have been unsuccessful
C4591001
1036
10361073 2 151 22FEB2021 FOLLOW -UP LOST TO FOLLOW -UP Lost to follow -up
C4591001
1037
10371078 1 44 08OCT2020 VACCINATION LOST TO FOLLOW -UP SITE ATTEMPTED CONTACT ON 22 SEP 30 SEP
AND CERTIFIED LETTER SENT 8 OCT NO
RESPONSE
1 44 08OCT2020 FOLLOW -UP LOST TO FOLLOW -UP CERTIFIED LETTER SENT 8 ONT. PT DID NOT
RESPOND
C4591001
1039
10391093 2 137 08FEB2021 FOLLOW -UP LOST TO FOLLOW -UP Contacted multiple times via phone and email, and
was sent certified letter, all with no response
090177e196ac9156\Final\Final On: 31-Mar-2021 13:05 (GMT)
Page 6
FDA-CBER-2022-5812-0223782
16.2.1.1.1 Listing of Subjects Discontinued From Vaccination and/or From the Study –
Subjects 12 Through 25 Years of Ag e
Age
Group
(Years) Subject Dose
No. Rel
Daya Withdrawal
Date Study Phase Withdrawal Reason Commentb
C4591001
1039
10391244 1 13 23NOV2020 VACCINATION NO LONGER MEETS
ELIGIBILITY CRITERIA Patient tested positive for COVID -19.
C4591001
1042
10421112 2 111 28DEC2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT withdrew consent
C4591001
1044
10441287 1 19 29DEC2020 VACCINATION OTHER subject proceeded to open label prior to Vax2 in the
blinded treatment phase.
C4591001
1048
10481088 2 49 12NOV2020 VACCINATION OTHER out of state at time of visit 3
C4591001
1052
10521054 1 25 21SEP2020 VACCINATION LOST TO FOLLOW -UP n/a
1 25 21SEP2020 FOLLOW -UP LOST TO FOLLOW -UP lost to follow up
C4591001
1052
10521064 1 25 24SEP2020 VACCINATION LOST TO FOLLOW -UP n/a
1 25 24SEP2020 FOLLOW -UP LOST TO FOLLOW -UP lost of follow up
C4591001
1052
10521080 1 28 29SEP2020 VACCINATION LOST TO FOLLOW -UP lost of follow up
1 28 29SEP2020 FOLLOW -UP LOST TO FOLLOW -UP lost of follow up
C4591001
1054
10541007 2 130 15JAN2021 FOLLOW -UP WITHDRAWAL BY
SUBJECT unblinding of subject occurred due to future non -
study covid -19 vaccination
C4591001
1054
10541022 1 64 23OCT2020 VACCINATION LOST TO FOLLOW -UP Pt deemed LTFU by site.
090177e196ac9156\Final\Final On: 31-Mar-2021 13:05 (GMT)
Page 7
FDA-CBER-2022-5812-0223783
16.2.1.1.1 Listing of Subjects Discontinued From Vaccination and/or From the Study –
Subjects 12 Through 25 Years of Ag e
Age
Group
(Years) Subject Dose
No. Rel
Daya Withdrawal
Date Study Phase Withdrawal Reason Commentb
1 64 23OCT2020 FOLLOW -UP LOST TO FOLLOW -UP Pt deemed LTFU by site.
C4591001
1054
10541165 2 47 24NOV2020 VACCINATION LOST TO FOLLOW -UP Subj. did not show up for V3, despite sending
certified letter and contacting pt via phone 3 times.
2 47 24NOV2020 FOLLOW -UP LOST TO FOLLOW -UP Subj. did not show up for V3, despite sending
certified letter and contacting pt via phone 3 times.
C4591001
1056
10561392 2 73 13JAN2021 VACCINATION LOST TO FOLLOW -UP Subject was discontinued from study after several
unsuccessful TC and a Certified Letter.
2 73 13JAN2021 FOLLOW -UP LOST TO FOLLOW -UP Subject was discontinued from study after several
unsuccessful TC and a Certified Letter.
C4591001
1056
10561511 2 103 12FEB2021 FOLLOW -UP WITHDRAWAL BY
SUBJECT Subject informed us he no longer wanted to continue
in the study.
C4591001
1056
10561554 1 86 13JAN2021 VACCINATION LOST TO FOLLOW -UP Subject was discontinued from study after several
unsuccessful TC and a Certified Letter.
1 86 13JAN2021 FOLLOW -UP LOST TO FOLLOW -UP Subject was discontinued from study after several
unsuccessful TC and a Certified Letter.
C4591001
1056
10561592 2 81 18FEB2021 VACCINATION LOST TO FOLLOW -UP After many attempts to contact subject, Investigator
decided to discontinue Pt. as a LTFU
2 81 18FEB2021 FOLLOW -UP LOST TO FOLLOW -UP After many attempts to contact subject, Investigator
decided to discontinue Pt. as a LTFU
C4591001
1057
10571211
18SEP2020 FOLLOW -UP NO LONGER MEETS
ELIGIBILITY CRITERIA subject was randomized but failed to meet entry
criteria, no vaccine was given
C4591001
1057
10571216 2 30 10NOV2020 VACCINATION WITHDRAWAL BY
SUBJECT MOVED TO SAN FRANCISCO
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Page 8
FDA-CBER-2022-5812-0223784
16.2.1.1.1 Listing of Subjects Discontinued From Vaccination and/or From the Study –
Subjects 12 Through 25 Years of Ag e
Age
Group
(Years) Subject Dose
No. Rel
Daya Withdrawal
Date Study Phase Withdrawal Reason Commentb
2 30 10NOV2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT MOVED TO SAN FRANCISCO
C4591001
1057
10571230 2 56 23DEC2020 VACCINATION WITHDRAWAL BY
SUBJECT PERSONAL REASONS
2 56 23DEC2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT PERSONAL REASONS
C4591001
1057
10571248 1 36 30OCT2020 VACCINATION WITHDRAWAL BY
SUBJECT subject refused to return for Visit 2, withdrew
consent, No adverse events reported
1 36 30OCT2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT subject withdrew consent from further study
participation
C4591001
1057
10571319 2 47 28DEC2020 VACCINATION WITHDRAWAL BY
SUBJECT withdrew consent due to transportation issues
2 47 28DEC2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT withdrew consent due to transportation issues
C4591001
1066
10661396 1 22 22DEC2020 VACCINATION OTHER unblinded to assess eligibility for vaccination
C4591001
1073
10731038 1 37 10SEP2020 VACCINATION LOST TO FOLLOW -UP Subject was Discontinue
1 37 10SEP2020 FOLLOW -UP LOST TO FOLLOW -UP Discontinue
C4591001
1073
10731067 2 157 05FEB2021 FOLLOW -UP WITHDRAWAL BY
SUBJECT Subject Withdrew Consent
C4591001
1079
10791253 1 67 13NOV2020 VACCINATION LOST TO FOLLOW -UP patient unresponsive
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Page 9
FDA-CBER-2022-5812-0223785
16.2.1.1.1 Listing of Subjects Discontinued From Vaccination and/or From the Study –
Subjects 12 Through 25 Years of Ag e
Age
Group
(Years) Subject Dose
No. Rel
Daya Withdrawal
Date Study Phase Withdrawal Reason Commentb
1 67 13NOV2020 FOLLOW -UP LOST TO FOLLOW -UP patient unresponsive
C4591001
1080
10801019 2 155 01FEB2021 FOLLOW -UP PROTOCOL DEVIATION Patient received vaccine outside of the study.
C4591001
1080
10801055 2 105 21DEC2020 FOLLOW -UP PROTOCOL DEVIATION Patient was vaccinated for COVID by her employer
prior to being unblinded
C4591001
1084
10841512 2 119 09MAR2021 FOLLOW -UP WITHDRAWAL BY
SUBJECT subject will not be available for follow -up
appointments.
C4591001
1085
10851081 2 87 30NOV2020 VACCINATION WITHDRAWAL BY
SUBJECT Subject no longer interested in the study.
2 87 30NOV2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT Site received call call from patient stating she was no
longer interested in the study.
C4591001
1085
10851244 2 97 30DEC202 0 FOLLOW -UP PROTOCOL DEVIATION Received vaccine elsewhere
C4591001
1087
10871089 1 19 04SEP2020 VACCINATION NO LONGER MEETS
ELIGIBILITY CRITERIA Exclusion Criteria #5
C4591001
1087
10871279 2 156 23FEB2021 FOLLOW -UP WITHDRAWAL BY
SUBJECT Subject is unwilling to return for vaccine if in the
placebo group.
C4591001
1087
10871354 1 10 17SEP2020 VACCINATION ADVERSE EVENT ADVERSE EVENT/MYALGIA
1 10 17SEP2020 FOLLOW -UP ADVERSE EVENT ADVERSE EVENT/MYALGIA
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Page 10
FDA-CBER-2022-5812-0223786
16.2.1.1.1 Listing of Subjects Discontinued From Vaccination and/or From the Study –
Subjects 12 Through 25 Years of Ag e
Age
Group
(Years) Subject Dose
No. Rel
Daya Withdrawal
Date Study Phase Withdrawal Reason Commentb
C4591001
1087
10871356 1 54 31OCT2020 VACCINATION LOST TO FOLLOW -UP Lost to follow up.
1 54 31OCT2020 FOLLOW -UP LOST TO FOLLOW -UP Lost to follow up.
C4591001
1087
10871363 2 56 23NOV2020 VACCINATION LOST TO FOLLOW -UP lost to follow up
2 56 23NOV2020 FOLLOW -UP LOST TO FOLLOW -UP Lost to follow up.
C4591001
1089
10891179 2 157 18FEB2021 FOLLOW -UP WITHDRAWAL BY
SUBJECT subject moved, withdrew consent
C4591001
1090
10901328 2 63 25NOV2020 VACCINATION LOST TO FOLLOW -UP pt did not come for V3 and was unresponsive to calls
and certified letter
2 63 25NOV2020 FOLLOW -UP LOST TO FOLLOW -UP Pt did not come for V3 and not responsive to calls or
certified letter
C4591001
1090
109015 17 2 49 29DEC2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT Subject requested to be unblinded before eligibility
C4591001
1091
10911122 2 169 16FEB2021 FOLLOW -UP PROTOCOL DEVIATION Subject received moderna vaccine
C4591001
1092
10921055 2 138 29JAN2021 FOLLOW -UP LOST TO FOLLOW -UP Subject is lost to follow -up
C4591001
1092
10921128
01SEP2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT Pt withdrew consent due to anxiety of having blood
drawn
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Page 11
FDA-CBER-2022-5812-0223787
16.2.1.1.1 Listing of Subjects Discontinued From Vaccination and/or From the Study –
Subjects 12 Through 25 Years of Ag e
Age
Group
(Years) Subject Dose
No. Rel
Daya Withdrawal
Date Study Phase Withdrawal Reason Commentb
C4591001
1093
10931055
31AUG2020 FOLLOW -UP NO LONGER MEETS
ELIGIBILITY CRITERIA UNABLE TO OBTAIN BLOOD FROM SUBJECT.
C4591001
1093
10931058 1 25 18SEP2020 VACCINATION PREGNANCY PREGNANCY/EXPOSURE DURING
PREGNANCY
1 77 09NOV2020 FOLLOW -UP LOST TO FOLLOW -UP Subject was lost to follow up./EXPOSURE DURING
PREGNANCY
C4591001
1093
10931072 1 81 14NOV2020 VACCINATION LOST TO FOLLOW -UP SUBJECT WAS SENT A CERTIFIED LETTER
AND WAS UNABLE TO BE CONTACTED
MULTIPLE TIMES.
1 81 14NOV2020 FOLLOW -UP LOST TO FOLLOW -UP SUBJECT WAS SENT A CERTIFIED LETTER
AND WAS UNABLE TO BE CONTACTED
MULTIPLE TIMES.
C4591001
1094
10941169 2 120 23FEB2021 FOLLOW -UP PROTOCOL DEVIATION subject received the non study covid 19 vaccine
before being discontinued or withdra wing from study
C4591001
1095
10951056 1 35 08SEP2020 VACCINATION OTHER not able to meet study requirements due to work
schedule
1 35 08SEP2020 FOLLOW -UP OTHER Participant not able to continue in study at this time.
Participant did not withdraw consent
C4591001
1095
10951271 2 1 28OCT2020 VACCINATION LOST TO FOLLOW -UP certified letter sent
2 1 28OCT2020 FOLLOW -UP LOST TO FOLLOW -UP certified letter sent
C4591001
1096
10961031 1 22 04SEP2020 VACCINATION PREGNANCY PREGNANCY/EXPOSURE DURING
PREGNANCY
090177e196ac9156\Final\Final On: 31-Mar-2021 13:05 (GMT)
Page 12
FDA-CBER-2022-5812-0223788
16.2.1.1.1 Listing of Subjects Discontinued From Vaccination and/or From the Study –
Subjects 12 Through 25 Years of Ag e
Age
Group
(Years) Subject Dose
No. Rel
Daya Withdrawal
Date Study Phase Withdrawal Reason Commentb
C4591001
1096
10961081 1 54 12OCT2020 VACCINATION LOST TO FOLLOW -UP LTFU, unresponsive to contact attempts
1 54 12OCT2020 FOLLOW -UP LOST TO FOLLOW -UP site unable to contact subject after multiple attempts
and certified letter sent
C4591001
1096
10961141 1 22 16SEP2020 VACCINATION NO LONGER MEETS
ELIGIBILITY CRITERIA Exclusion criteria #5
C4591001
1096
10961321 1 22 03OCT2020 VACCINATION NO LONGER MEETS
ELIGIBILITY CRITERIA subject met exclusion #1 on visit 2 (suicidal ideation)
so no vaccine was administered
C4591001
1096
10961388 1 21 29OCT2020 VACCINATION NO LONGER MEETS
ELIGIBILITY CRITERIA subject was diagnosed with COVID between
vaccination one and vaccination two
C4591001
1098
10981200 1 46 05NOV2020 VACCINATION LOST TO FOLLOW -UP Subject called multiple times and certified letter was
sent. No response from subject
1 46 05NOV2020 FOLLOW -UP LOST TO FOLLOW -UP Subject called multiple times and certified letter was
sent. No response from subject.
C4591001
1098
10981243 2 139 08MAR2021 FOLLOW -UP LOST TO FOLLOW -UP Discontinued
C4591001
1098
10981244 2 84 12JAN2021 FOLLOW -UP LOST TO FOLLOW -UP Subject has been discontinued due to lost of
followup.
C4591001
1109
11091030 2 37 23SEP2020 VACCINATION WITHDRAWAL BY
SUBJECT SUBJECT CALLED TO WITHDRAW FROM
TRIAL DUE TO TRANSPORTATION ISSUES AS
WELL AS BEING TO BUSY.
2 37 23SEP2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT SUBJECT CALLED TO WITHDRAW FROM
TRIAL DUE TO TRANSPORTATION ISSUES AS
WELL AS BEING TO BUSY.
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Page 13
FDA-CBER-2022-5812-0223789
16.2.1.1.1 Listing of Subjects Discontinued From Vaccination and/or From the Study –
Subjects 12 Through 25 Years of Ag e
Age
Group
(Years) Subject Dose
No. Rel
Daya Withdrawal
Date Study Phase Withdrawal Reason Commentb
C4591001
1109
11091059 1 40 08SEP2020 VACCINATION LOST TO FOLLOW -UP SUBJECT NEVER RETURNED PHONE CALLS
OR RESPOND TO CERTIFIED LETTER.
1 40 08SEP2020 FOLLO W-UP LOST TO FOLLOW -UP SUBJECT NEVER RETURNED PHONE CALLS
OR RESPOND TO CERTIFIED LETTER.
C4591001
1109
11091335 1 43 07OCT2020 VACCINATION LOST TO FOLLOW -UP SUBJECT NEVER RESPONDED TO MULTIPLE
CALLS AND CERTIFIED LETTER SENT TO HER
1 43 07OCT2020 FOLLOW -UP LOST TO FOLLOW -UP SUBJECT NEVER RESPONDED TO MULTIPLE
CALLS AND CERTIFIED LETTER SENT TO HER
C4591001
1109
11091515 1 30 14OCT2020 VACCINATION LOST TO FOLLOW -UP Subject never returned for visit, responded to call or
certified letter sent.
1 30 14OCT2020 FOLLOW -UP LOST TO FOLLOW -UP Subject never returned for visit, responded to call or
certified letter sent.
C4591001
1110
11101010 2 63 22OCT2020 VACCINATION LOST TO FOLLOW -UP Subject did not comply with inclusion criteria #2.
2 63 22OCT2020 FOLLOW -UP LOST TO FOLLOW -UP Subject did not comply with inclusion criteria #2.
C4591001
1110
11101038 1 35 08SEP2020 VACCINATION LOST TO FOLLOW -UP Subject was contact over the phone 3 times and a
certified letter was sent. Subject never reply.
1 35 08SEP2020 FOLLOW -UP LOST TO FOLLOW -UP Lost to follow is status, subject has been withdrawn
from trial.
C4591001
1110
11101039 1 35 08SEP2020 VACCINATION LOST TO FOLLOW -UP subject failed to contact site after many calls and
certified letter.
1 35 08SEP2020 FOLLOW -UP LOST TO FOLLOW -UP Subject did not respond to many phones calls from
site and did not respond to certified letter fromi
090177e196ac9156\Final\Final On: 31-Mar-2021 13:05 (GMT)
Page 14
FDA-CBER-2022-5812-0223790
16.2.1.1.1 Listing of Subjects Discontinued From Vaccination and/or From the Study –
Subjects 12 Through 25 Years of Ag e
Age
Group
(Years) Subject Dose
No. Rel
Daya Withdrawal
Date Study Phase Withdrawal Reason Commentb
C4591001
1110
11101085 1 58 08OCT2 020 VACCINATION LOST TO FOLLOW -UP Subject was tried to contact by phone, text, email and
certified letter several times.
1 58 08OCT2020 FOLLOW -UP LOST TO FOLLOW -UP we did 4 phone call attempts, 1 text message, 1 email
and a certified letter.
C4591001
1110
11101110 1 22 08SEP2020 VACCINATION WITHDRAWAL BY
SUBJECT Subject withdrew consent
1 22 08SEP2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT subject withdrew consent
C4591001
1110
11101156 1 96 01DEC2020 VACCINATION LOST TO FOLLOW -UP Subject was attempt to contact by 2 text messages, 1
certified letter, 1 email and 8 phone call.
1 96 01DEC2020 FOLLOW -UP LOST TO FOLLOW -UP Subject was attempt to contact by 2 text messages, 1
certified letter, 1 email and 8 phone call.
C4591001
1110
11101380 2 38 29JAN2021 VACCINATION WITHDRAWAL BY
PARENT/GUARDIAN Parent discontinue subject because he states subject is
too busy with school.
2 38 29JAN2021 FOLLOW -UP WITHDRAWAL BY
PARENT/GUARDIAN Parent discontinued subject because he states subject
is too busy with school.
C4591001
1112
11121058 1 22 25AUG202 0 VACCINATION OTHER
1 22 25AUG2020 FOLLOW -UP OTHER
C4591001
1112
11121229
04SEP2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT subject left clinic after randomization and prior to
vaccination
C4591001
1116
11161292 1 52 14NOV2020 VACCINATION LOST TO FOLLOW -UP Contact attempts 16OCT 22OCT 23OCT 3NOV
4NOV 9NOV 10NOV
090177e196ac9156\Final\Final On: 31-Mar-2021 13:05 (GMT)
Page 15
(b) (6)
(b) (6)
FDA-CBER-2022-5812-0223791
16.2.1.1.1 Listing of Subjects Discontinued From Vaccination and/or From the Study –
Subjects 12 Through 25 Years of Ag e
Age
Group
(Years) Subject Dose
No. Rel
Daya Withdrawal
Date Study Phase Withdrawal Reason Commentb
1 52 14NOV2020 FOLLOW -UP LOST TO FOLLOW -UP Contact attempts 16OCT 22OCT 23OCT 3NOV
4NOV 9NOV 10NOV
C4591001
1116
11161322 2 55 07DEC2020 VACCINATION WITHDRAWAL BY
SUBJECT SUBJECT WITHDREW FROM STUDY
2 55 07DEC2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT Subject withdrew consent
C4591001
1117
11171138 2 31 17DEC2020 VACCINATION PROTOCOL DEVIATION COULD NOT GET PARTICIPANT SCHEDULED
FOR V3
C4591001
1120
11201038
29OCT2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT Subject withdraw consent
C4591001
1120
11201240 2 163 20FEB2021 FOLLOW -UP WITHDRAWAL BY
SUBJECT subject is moving out of town
C4591001
1121
11211009 2 40 22OCT2020 VACCINATION WITHDRAWAL BY
SUBJECT Subject withdrew due to busy schedule.
2 40 22OCT2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT Subject withdrew consent due to busy schedule. Does
not want to be FU
C4591001
1121
11211010 2 180 11MAR2021 FOLLOW -UP WITHDRAWAL BY
SUBJECT Subject asked to be withdrawn then hung up.
Attempted to reach her again, she answered then
hung up.
C4591001
1121
11211067 2 100 30DEC2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT Subject withdrew consent to receive vaccine at work.
C4591001
1122
11221026
11SEP2020 FOLLOW -UP ADVERSE EVENT ADVERSE EVENT/PRESYNCOPE
090177e196ac9156\Final\Final On: 31-Mar-2021 13:05 (GMT)
Page 16
FDA-CBER-2022-5812-0223792
16.2.1.1.1 Listing of Subjects Discontinued From Vaccination and/or From the Study –
Subjects 12 Through 25 Years of Ag e
Age
Group
(Years) Subject Dose
No. Rel
Daya Withdrawal
Date Study Phase Withdrawal Reason Commentb
11SEP2020 FOLLOW -UP ADVERSE EVENT ADVERSE EVENT/VOMITING
C4591001
1123
11231027
04AUG2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT subject withdrew consent after randomization prior to
vaccination.
C4591001
1123
11231051 2 43 08OCT2020 VACCINATION OTHER moved to hawaii
2 43 08OCT2020 FOLLOW -UP OTHER Moved to Hawaii
C4591001
1123
11231069 2 190 09MAR2021 FOLLOW -UP LOST TO FOLLOW -UP Certified letter sent. Left voicemail with the patient.
C4591001
1123
11231154 1 73 04NOV2020 VACCINATION LOST TO FOLLOW -UP no response from subject after certified letter
1 73 04NOV2020 FOLLOW -UP LOST TO FOLLOW -UP no response from subject after certified letter
C4591001
1124
11241038 2 106 16DEC2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT Subject withdrew to receive Covid -19 at workplace
C4591001
1124
11241049 1 26 11SEP2020 VACCINATION LOST TO FOLLOW -UP Subject not responding to any phone calls, certified
letter sent
1 26 11SEP2020 FOLLOW -UP LOST TO FOLLOW -UP Subject not responding to any phone calls, certified
letter sent
C4591001
1124
11241141 2 64 24NOV2020 VACCINATION LOST TO FOLLOW -UP Lost to follow up after multiple calls and certified
letter sent
2 64 24NOV2020 FOLLOW -UP LOST TO FOLLOW -UP LOST TO FOLLOW -UP
C4591001
1125
11251059 2 76 24NOV2020 VACCINATION LOST TO FOLLOW -UP Subject missed appt and diary entries. Multiple
contact attempts with subject were not returned.
090177e196ac9156\Final\Final On: 31-Mar-2021 13:05 (GMT)
Page 17
FDA-CBER-2022-5812-0223793
16.2.1.1.1 Listing of Subjects Discontinued From Vaccination and/or From the Study –
Subjects 12 Through 25 Years of Ag e
Age
Group
(Years) Subject Dose
No. Rel
Daya Withdrawal
Date Study Phase Withdrawal Reason Commentb
2 76 24NOV2020 FOLLOW -UP LOST TO FOLLOW -UP Patient deemed lost to follow
C4591001
1125
11251142 2 154 24FEB2021 FOLLOW -UP WITHDRAWAL BY
SUBJECT moved from the area no longer able to make visits
C4591001
1125
11251238 1 12 02NOV2020 VACCINATION NO LONGER MEETS
ELIGIBILITY CRITERIA Patient tested positive for Covid -19, EXC #5
C4591001
1125
11251243 1 2 09DEC2020 VACCINATI ON ADVERSE EVENT ADVERSE EVENT/HEADACHE
1 2 09DEC2020 VACCINATION ADVERSE EVENT ADVERSE EVENT/INJECTION SITE PAIN
C4591001
1127
11271078 2 137 11JAN2021 FOLLOW -UP LOST TO FOLLOW -UP Lost to followup
C4591001
1127
11271099 1 22 09SEP2020 VACCINATION NO LONGER MEETS
ELIGIBILITY CRITERIA Subject tested positive and symptoms for COVID
C4591001
1128
11281177 2 113 19JAN2021 FOLLOW -UP PROTOCOL DEVIATION SUBJECT RECEIVED COVID -19 VACCINE
OUTSIDE OF STUDY
C4591001
1129
11291048
04AUG2020 VACCINATION NO LONGER MEETS
ELIGIBILITY CRITERIA screen fail
04AUG2020 FOLLOW -UP PROTOCOL DEVIATION violation exclusion criteria 2.f. immunocompromised.
randomized but not dosed
C4591001
1129
11291260 2 44 27JAN2021 OPEN LABEL
TREATMENT ADVERSE EVENT ADVERSE EVENT/ANAPHYLACTOID
REACTION
090177e196ac9156\Final\Final On: 31-Mar-2021 13:05 (GMT)
Page 18
FDA-CBER-2022-5812-0223794
16.2.1.1.1 Listing of Subjects Discontinued From Vaccination and/or From the Study –
Subjects 12 Through 25 Years of Ag e
Age
Group
(Years) Subject Dose
No. Rel
Daya Withdrawal
Date Study Phase Withdrawal Reason Commentb
C4591001
1133
11331037 1 27 26AUG2020 VACCINATION WITHDRAWAL B Y
SUBJECT Subject withdrew consent.
1 27 26AUG2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT SUBJECT WITHDREW CONSENT
C4591001
1133
11331047 2 8 31AUG2020 VACCINATION WITHDRAWAL BY
SUBJECT Subject does not want to continue in the study
2 8 31AUG2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT SUBJECT WITHDREW CONSENT
C4591001
1133
11331135 2 166 16FEB2021 FOLLOW -UP WITHDRAWAL BY
SUBJECT Subject withdrew consent after unblinding.
Requested time to think about it. Made decision on
16/FEB
C4591001
1133
11331207 1 43 30SEP2020 VACCINATION WITHDRAWAL BY
SUBJECT SUBJECT WITHDREW CONSENT
1 43 30SEP2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT Subject withdrew consent
C4591001
1133
11331480 2 127 23FEB2021 FOLLOW -UP LOST TO FOLLOW -UP CERTIFIED LETTER SENT 08/FEB/2021
C4591001
1133
11331647 2 31 23DEC2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT Subject leaving and does not want to come in for any
future visits.
C4591001
1135
11351199 1 39 01OCT2020 VACCINATION LOST TO FOLLOW -UP Lost to follow up, certified letter sent to patient.
1 39 01OCT2020 FOLLOW -UP LOST TO FOLLOW -UP subject lost to follow -up, certified letter sent
090177e196ac9156\Final\Final On: 31-Mar-2021 13:05 (GMT)
Page 19
FDA-CBER-2022-5812-0223795
16.2.1.1.1 Listing of Subjects Discontinued From Vaccination and/or From the Study –
Subjects 12 Through 25 Years of Ag e
Age
Group
(Years) Subject Dose
No. Rel
Daya Withdrawal
Date Study Phase Withdrawal Reason Commentb
C4591001
1135
11351428 1 27 19OCT2020 VACCINATION LOST TO FOLLOW -UP subject contact attempted several times and certified
letter was sent on 19OCT2020
1 27 19OCT2020 FOLLOW -UP LOST TO FOLLOW -UP subject contact attempted several times and certified
letter was sent on 19OCT2020
C4591001
1141
11411077 2 118 04JAN2021 FOLLOW -UP WITHDRAWAL BY
SUBJECT subject withdrew to receive EUA vaccine outside of
the study.
C4591001
1146
11461140 2 178 13MAR2021 FOLLOW -UP WITHDRAWAL BY
SUBJECT subject withdrew
C4591001
1149
11491332 2 23 03DEC2020 VACCINATION WITHDRAWAL BY
SUBJECT subject moved out of State and will not be able to
committee to follow -ups
2 23 03DEC2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT Subject moved out of state and withdrew from study.
C4591001
1152
11521030 1 22 02SEP2020 VACCINATION PHYSICIAN DECISION PHYSI CIAN DECISION
C4591001
1152
11521208 2 81 04DEC2020 VACCINATION PROTOCOL DEVIATION Non-compliant with attending study visits.
2 115 07JAN2021 FOLLOW -UP PHYSICIAN DECISION PHYSICIAN DECISION
C4591001
1156
11561015 1 39 28SEP2020 VACCINATION PREGNANCY PREGNANCY/EXPOSURE DURING
PREGNANCY
C4591001
1157
11571077 2 30 14OCT2020 VACCINATION WITHDRAWAL BY
SUBJECT Subject W/C due to moving
090177e196ac9156\Final\Final On: 31-Mar-2021 13:05 (GMT)
Page 20
FDA-CBER-2022-5812-0223796
16.2.1.1.1 Listing of Subjects Discontinued From Vaccination and/or From the Study –
Subjects 12 Through 25 Years of Ag e
Age
Group
(Years) Subject Dose
No. Rel
Daya Withdrawal
Date Study Phase Withdrawal Reason Commentb
2 30 14OCT2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT Voluntary withdrawal not due to an AE or SAE
C4591001
1161
11611006 1 111 18NOV2020 VACCINATION WITHDRAWAL BY
SUBJECT Subject chose to withdraw from study
1 111 18NOV2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT Subject chose to withdraw from study.
C4591001
1161
11611007 1 103 10NOV2020 VACCINATION NO LONGER MEETS
ELIGIBILITY CRITERIA No longer meets an eligibility criteria per exclusion
#5. VAX2 is not given but FUP will be complete
1 146 23DEC2020 FOLLOW -UP LOST TO FOLLOW -UP unable to contact, certified letter was sent and no
response.
C4591001
1161
11611008 1 103 10NOV2020 VACCINATION NO LONGER MEETS
ELIGIBILITY CRITERIA Exclusion criterion 5
C4591001
1161
11611010 1 134 11DEC2020 VACCINATION PHYSICIAN DECISION PHYSICIAN DECISION
1 216 03MAR2021 FOLLOW -UP WITHDRAWAL BY
SUBJECT subject stated he did not want to continue in study.
C4591001
1161
11611018 1 115 23NOV2020 VACCINATION LOST TO FOLLOW -UP multiple calls and cert. letter sent. No response from
subject.
1 115 23NOV2020 FOLLOW -UP LOST TO FOLLOW -UP multiple calls and certified letter sent. no response
from subject
C4591001
1161
11611023 1 72 13OCT2020 VACCINATION LOST TO FOLLOW -UP subject had several contact attempts by site along
with certified letter. Unable to contact subject.
1 72 13OCT2020 FOLLOW -UP LOST TO FOLLOW -UP cert. letter sent and signed by subject. unable to
contact and subject has not called sit e.
090177e196ac9156\Final\Final On: 31-Mar-2021 13:05 (GMT)
Page 21
FDA-CBER-2022-5812-0223797
16.2.1.1.1 Listing of Subjects Discontinued From Vaccination and/or From the Study –
Subjects 12 Through 25 Years of Ag e
Age
Group
(Years) Subject Dose
No. Rel
Daya Withdrawal
Date Study Phase Withdrawal Reason Commentb
C4591001
1161
11611024 1 107 17NOV2020 VACCINATION WITHDRAWAL BY
SUBJECT unable to contact subject. certified letter returned, no
response from subject
1 107 17NOV2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT subject did not want to continue in study
C4591001
1161
11611028 2 83 02FEB2021 FOLLOW -UP LOST TO FOLLOW -UP 3 phone call attempts and certified letter sent with no
response.
C4591001
1162
11621005 1 32 31AUG2020 VACCINATION WITHDRAWAL BY
SUBJECT The subject prematurely withdrew from study.
1 32 31AUG2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT subject prematurely withdrawn from study.
C4591001
1162
11621044 2 194 09MAR2021 FOLLOW -UP LOST TO FOLLOW -UP Lost to follow -up
C4591001
1162
11621074 2 73 13NOV2020 VACCINATION LOST TO FOLLOW -UP subject LTFU after multiple contact attempts.
2 73 13NOV2020 FOLLOW -UP LOST TO FOLLOW -UP subject LTFU after multiple contact attempts.
C4591001
1162
11621080 2 64 04NOV2020 VACCINATION LOST TO FOLLOW -UP Subject LTFU
2 64 04NOV2020 FOLLOW -UP LOST TO FOLLOW -UP Subject LTFU
C4591001
1162
11621310 1 60 06NOV2020 VACCINATION LOST TO FOLLOW -UP Subject LTFU
1 60 06NOV2020 FOLLOW -UP LOST TO FOLLOW -UP Subject LTFU
090177e196ac9156\Final\Final On: 31-Mar-2021 13:05 (GMT)
Page 22
FDA-CBER-2022-5812-0223798
16.2.1.1.1 Listing of Subjects Discontinued From Vaccination and/or From the Study –
Subjects 12 Through 25 Years of Ag e
Age
Group
(Years) Subject Dose
No. Rel
Daya Withdrawal
Date Study Phase Withdrawal Reason Commentb
C4591001
1162
11621374 1 54 06NOV2020 VACCINATION LOST TO FOLLOW -UP Subject LTFU
1 54 06NOV2020 FOLLOW -UP LOST TO FOLLOW -UP Subject LTFU after many contact attempts.
C4591001
1162
11621434 2 1 19OCT2020 VACCINATION LOST TO FOLLOW -UP LOST TO FOLLOW -UP
2 1 19OCT2020 FOLLOW -UP LOST TO FOLLOW -UP LOST TO FOLLOW -UP
C4591001
1167
11671111 1 38 08OCT2020 VACCINATION LOST TO FOLLOW -UP Subject is lost to follow up tried multiple calls and
certified letter
1 38 08OCT2020 FOLLOW -UP LOST TO FOLLOW -UP no answer after multiple calls and sent certified letter
C4591001
1167
11671132 2 98 28DEC2020 FOLLOW -UP PROTOCOL DEVIATION subject received out of study covid vaccine
C4591001
1168
11681212 2 1 15OCT2020 VACCINATION OTHER The visit was missed due to pt working out of state.
The subject will continue on in the study.
C4591001
1168
11681221 2 54 21DEC2020 VACCINATION WITHDRAWAL BY
SUBJECT subject chose to no longer participate, complete study
procedures, or respond to follow up requests.
2 54 21DEC2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT subject chose to no longer participate, complete study
procedures, or respond to follow up requests.
C4591001
1168
11681227 1 37 17NOV2020 VACCINATION LOST TO FOLLOW -UP Subject LTF after several attempts to contact and
certified letter sent
1 37 17NOV2020 FOLLOW -UP LOST TO FOLLOW -UP Subject LTF after several attempts to contact and
certified letter sent
090177e196ac9156\Final\Final On: 31-Mar-2021 13:05 (GMT)
Page 23
FDA-CBER-2022-5812-0223799
16.2.1.1.1 Listing of Subjects Discontinued From Vaccination and/or From the Study –
Subjects 12 Through 25 Years of Ag e
Age
Group
(Years) Subject Dose
No. Rel
Daya Withdrawal
Date Study Phase Withdrawal Reason Commentb
C4591001
1169
11691014 2 104 04JAN2021 FOLLOW -UP WITHDRAWAL BY
SUBJECT Subject did not want to wait 28 days to receive study
vaccine after receiving HPV vaccine 12/21/20
C4591001
1169
11691060 2 36 17NOV2020 VACCINATION LOST TO FOLLOW -UP Lost to Follow Up
2 36 17NOV2020 FOLLOW -UP LOST TO FOLLOW -UP Lost to follow up
C4591001
1170
11701048 2 166 23FEB2021 FOLLOW -UP LOST TO FOLLOW -UP multiple attempts have been made to contact subject
with no response
C4591001
1170
11701076 2 163 23FEB2021 FOLLOW -UP LOST TO FOLLOW -UP multiple attempts have been made to contact subject
with no response
C4591001
1170
11701089 2 161 23FEB2021 FOLLOW -UP LOST TO FOLLOW -UP multiple attempts have been made to contact subject
with no response
C4591001
1170
11701146 2 168 09MAR2021 FOLLOW -UP LOST TO FOLLOW -UP lost to follow up subject contacted multiple times for
scheduling
C4591001
1170
11701311 1 33 16OCT2020 VACCINATION LOST TO FOLLOW -UP Subject contacted multiple times, never responded.
1 33 16OCT2020 FOLLOW -UP LOST TO FOLLOW -UP lost to follow -up subjects subject didnt come for visit.
C4591001
1170
11701487 2 99 23FEB2021 FOLLOW -UP LOST TO FOLLOW -UP multiple attempts have been mad e to contact subject
with no response
C4591001
1170
11701494 2 99 23FEB2021 VACCINATION LOST TO FOLLOW -UP multiple attempts have been made to contact subject
with no response
090177e196ac9156\Final\Final On: 31-Mar-2021 13:05 (GMT)
Page 24
FDA-CBER-2022-5812-0223800
16.2.1.1.1 Listing of Subjects Discontinued From Vaccination and/or From the Study –
Subjects 12 Through 25 Years of Ag e
Age
Group
(Years) Subject Dose
No. Rel
Daya Withdrawal
Date Study Phase Withdrawal Reason Commentb
2 99 23FEB2021 FOLLOW -UP LOST TO FOLLOW -UP multiple attempts have been made to contact subject
with no response
C4591001
1195
11951029 2 78 20JAN2021 FOLLOW -UP WITHDRAWAL BY
SUBJECT the upcoming visits is to stressful for the patient at
this time.
C4591001
1195
11951061 1 21 06NOV2020 VACCINATION WITHDRAWAL BY
SUBJECT patient withdrawal consent. she is afraid about the
second vaccination
1 21 06NOV2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT patient is afraid for the second vaccination
C4591001
1218
12181011 2 99 02MAR2021 VACCINATION WITHDRAWAL BY
SUBJECT We made contact with participant 02MAR2021, she
was informed of her vaccine status but withdrew.
2 99 02MAR2021 FOLLOW -UP WITHDRAWAL BY
SUBJECT Participant requested to withdraw from study as they
have moved out of state
C4591001
1218
12181050 1 21 23DEC2020 VACCINATION OTHER Subject proceeded to open label prior to Vax2 in
blinded treatment phase
C4591001
1220
12201036 1 44 17DEC2020 VACCINATION LOST TO FOLLOW -UP unable to contact participant due to multiple attempts
1 44 17DEC2020 FOLLOW -UP LOST TO FOLLOW -UP Unable to contact participant after multiple attempts
C4591001
1221
12211036 2 52 27JAN2021 FOLLOW -UP WITHDRAWAL BY
SUBJECT Withdrew from study
C4591001
1224
12241009 1 37 18SEP2020 VACCINATION LOST TO FOLLOW -UP PT failed to attend V2; site attempted contact via
phone and certified letter
1 37 18SEP2020 FOLLOW -UP LOST TO FOLLOW -UP PT failed to return for V2; site attempted contact via
phone a nd certified letter
090177e196ac9156\Final\Final On: 31-Mar-2021 13:05 (GMT)
Page 25
FDA-CBER-2022-5812-0223801
16.2.1.1.1 Listing of Subjects Discontinued From Vaccination and/or From the Study –
Subjects 12 Through 25 Years of Ag e
Age
Group
(Years) Subject Dose
No. Rel
Daya Withdrawal
Date Study Phase Withdrawal Reason Commentb
C4591001
1224
12241167 1 27 16DEC2020 VACCINATION NO LONGER MEETS
ELIGIBILITY CRITERIA Exclusion Criteria 5
C4591001
1224
12241169 2 23 06JAN2021 VACCINATION OTHER subject proceeded to open label prior to V3 in the
blinded Rx phase
C4591001
1224
12241170
24NOV2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT Subject chose to discontinue from trial
C4591001
1224
12241175 1 17 16DEC2020 VACCINATION NO LONGER MEETS
ELIGIBILITY CRITERIA Exclusion Criteria 5
C4591001
1226
12262189 1 14 27OCT2020 VACCINATION NO LONGER MEETS
ELIGIBILITY CRITERIA Exclusion criterion 5
C4591001
1230
12301065 2 97 02MAR2021 VACCINATION WITHDRAWAL BY
SUBJECT Participant translocated and will no longer be able to
attend site visits
2 97 02MAR2021 FOLLOW -UP WITHDRAWAL BY
SUBJECT Participant confirmed that he has translocated.
Attending additional visits will be difficult.
C4591001
1231
12311031 1 37 15SEP2020 VACCINATION NO LONGER MEETS
ELIGIBILITY CRITERIA Previous clinical or microbiological diagnosis of
COVID- 19
C4591001
1231
12311062 2 165 12FEB2021 FOLLOW -UP LOST TO FOLLOW -UP After multiple contact attempts, a registered letter is
sent. Subject receives it on 3FEB2021
C4591001
1231
12311088 1 48 28SEP2020 VACCINATION NO LONGER MEETS
ELIGIBILITY CRITERIA Previous clinical or microbiological diagnosis of
COVID- 19
090177e196ac9156\Final\Final On: 31-Mar-2021 13:05 (GMT)
Page 26
FDA-CBER-2022-5812-0223802
16.2.1.1.1 Listing of Subjects Discontinued From Vaccination and/or From the Study –
Subjects 12 Through 25 Years of Ag e
Age
Group
(Years) Subject Dose
No. Rel
Daya Withdrawal
Date Study Phase Withdrawal Reason Commentb
C4591001
1231
12311191 1 32 14SEP2020 VACCINATION NO LONGER MEETS
ELIGIBILITY CRITERIA Previous clinical or microbiological diagnosis of
COVID- 19
C4591001
1231
12311431 1 27 10SEP2020 VACCINATION WITHDRAWAL BY
SUBJECT The subject is afraid of exposure to COVID -19 in
next study visits
1 27 10SEP2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT you fear going to a health institution and that this will
expose you to be reinfected by SARS -COV2
C4591001
1231
12311593 2 147 01FEB2021 VACCINATION LOST TO FOLLOW -UP After multiple unanswered phone calls, a certified
letter was sent and it was never r esponded.
2 147 01FEB2021 FOLLOW -UP LOST TO FOLLOW -UP Volunteer with loss of follow -up
C4591001
1231
12311641 1 29 13SEP2020 VACCINATION NO LONGER MEETS
ELIGIBILITY CRITERIA Previous clinical or microbiological diagnosis of
COVID- 19
C4591001
1231
12311656 1 40 24SEP2020 VACCINATION NO LONGER MEETS
ELIGIBILITY CRITERIA Previous clinical or microbiological diagnosis of
COVID- 19
C4591001
1231
12312326 1 34 21SEP2020 VACCINATION NO LONGER MEETS
ELIGIBILITY CRITERIA Previous clinical or microbiological diagnosis of
COVID- 19
C4591001
1231
12312365 1 28 15SEP2020 VACCINATION NO LONGER MEETS
ELIGIBILITY CRITERIA Previous clinical or microbiological diagnosis of
COVID- 19
1 56 13OCT2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT subject decided to withdraw consent due to lack of
time
C4591001
1231
12312403 1 24 11SEP2020 VACCINATION WITHDRAWAL BY
SUBJECT The patient does not want to take the second dose.
090177e196ac9156\Final\Final On: 31-Mar-2021 13:05 (GMT)
Page 27
FDA-CBER-2022-5812-0223803
16.2.1.1.1 Listing of Subjects Discontinued From Vaccination and/or From the Study –
Subjects 12 Through 25 Years of Ag e
Age
Group
(Years) Subject Dose
No. Rel
Daya Withdrawal
Date Study Phase Withdrawal Reason Commentb
C4591001
1231
12312451 1 23 11SEP2020 VACCINATION NO LONGER MEETS
ELIGIBILITY CRITERIA Participants who are willing and able to comply with
all scheduled visits, vaccination plan, lab...
C4591001
1231
12312528 2 123 11JAN2021 FOLLOW -UP PROTOCOL DEVIATION On JAN -9-2021, subject received the Gam -COVID -
Vac vaccine (trade name Sputnik V).
C4591001
1231
12312594 1 77 04NOV2020 VACCINATION WITHDRAWAL BY
SUBJECT Stop participating for personal reasons
1 77 04NOV2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT Subject Withdraws his consent for personal reasons
C4591001
1231
12312916 1 20 09SEP2020 VACCINATION NO LONGER MEETS
ELIGIBILITY CRITERIA Previous clinical or mi crobiological diagnosis of
COVID- 19.
C4591001
1231
12313443
23AUG2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT randomized, no vaccinated
C4591001
1231
12313467 1 24 15SEP2020 VACCINATION WITHDRAWAL BY
SUBJECT the subject did not agree to be vaccinated a second
time,but will continue in the study
C4591001
1231
12313498 1 25 16SEP2020 VACCINATION WITHDRAWAL BY
SUBJECT the subject did not agree to be vaccinated a second
time,but will continue in the study
C4591001
1231
12313519 1 24 15SEP2020 VACCINATION WITHDRAWAL BY
SUBJECT Did not accept to receive second dose but accept
continue with the rest of study procedures
C4591001
1231
12313546 1 26 17SEP2020 VACCINATION WITHDRAWAL BY
SUBJECT Subject did not receive the second vaccination but
continued otherwise with study procedures
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FDA-CBER-2022-5812-0223804
16.2.1.1.1 Listing of Subjects Discontinued From Vaccination and/or From the Study –
Subjects 12 Through 25 Years of Ag e
Age
Group
(Years) Subject Dose
No. Rel
Daya Withdrawal
Date Study Phase Withdrawal Reason Commentb
C4591001
1231
12313622 1 24 16SEP2020 VACCINATION NO LONGER MEETS
ELIGIBILITY CRITERIA Healthy participants eligible for inclusion in the study
and Previous diagnosis of COVID -19
C4591001
1231
12313758 1 44 06OCT2020 VACCINATION NO LONGER MEETS
ELIGIBILITY CRITERIA Previous clinical or microbiological diagnosis of
COVID- 19
C4591001
1231
12313981 2 45 29OCT2020 VACCINATION WITHDRAWAL BY
SUBJECT The decision to stop participating must be a move to
the province of Santiago del Estero.
2 45 29OCT2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT The decision to stop participating must be a move to
the province of Santiago del Estero.
C4591001
1231
12314492 1 20 15SEP2020 VACCINATION NO LONGER MEETS
ELIGIBILITY CRITERIA Previous clinical or microbiological diagnosis of
COVI D-19
1 142 15JAN2021 FOLLOW -UP LOST TO FOLLOW -UP 12 telephone contact attempts. 2 email contact
attempts. 1 certified letter sent.
C4591001
1231
12315357 1 13 10SEP2020 VACCINATION WITHDRAWAL BY
SUBJECT The subject does not specify the reasons for
withdrawing from the study
1 13 10SEP2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT The subject does not specify the reasons for
withdrawing from the study
C4591001
1232
12321015 1 21 02SEP2020 VACCINATION LOST TO FOLLOW -UP patient is labeled a "no show"
1 21 02SEP2020 FOLLOW -UP LOST TO FOLLOW -UP patient labeled as a "no show"
C4591001
1232
12321142 1 24 23SEP2020 VACCINATION OTHER re-joined trial in the revaccination open label portion
090177e196ac9156\Final\Final On: 31-Mar-2021 13:05 (GMT)
Page 29
FDA-CBER-2022-5812-0223805
16.2.1.1.1 Listing of Subjects Discontinued From Vaccination and/or From the Study –
Subjects 12 Through 25 Years of Ag e
Age
Group
(Years) Subject Dose
No. Rel
Daya Withdrawal
Date Study Phase Withdrawal Reason Commentb
C4591001
1232
12321210 2 67 06DEC2020 VACCINATION LOST TO FOLLOW -UP multiple attempts to contact patient, phone is no
longer in service
2 67 06DEC2020 FOLLOW -UP LOST TO FOLLOW -UP multiple attempts to contact patient, phone is no
longer in service
C4591001
1232
12321244 1 1 11SEP2020 VACCINATION LOST TO FOLLOW -UP Subject did not attend V2 and would not return the
sites calls
1 1 11SEP2020 FOLLOW -UP LOST TO FOLLOW -UP Subject is not returning any of the sites phone calls.
Will not be rejoining.
C4591001
1232
12321412 1 1 27OCT2020 VACCINATION LOST TO FOLLOW -UP Subject did not attend V2 and would not return calls
from the site
1 1 27OCT2020 FOLLOW -UP LOST TO FOLL OW-UP Subject did not attend V2 and would not return calls
from the site
C4591001
1232
12321429 1 1 28OCT2020 VACCINATION LOST TO FOLLOW -UP Subject did not attend V2 and has not returned calls
from the site
1 1 28OCT2020 FOLLOW -UP LOST TO FOLLOW -UP Subject did not attend V2 and has not returned calls
from the site
C4591001
1235
12351187 1 9 24OCT2020 VACCINATION NO LONGER MEETS
ELIGIBILITY CRITERIA meets exclusion #5
C4591001
1247
12471107 2 29 17NOV2020 VACCINATION LOST TO FOLLOW -UP Pt did not arrive for Visit 3. After multiple attempts
by site staff, pt still did not arrive for V3
C4591001
1247
12471121 2 10 30OCT2020 VACCINATION WITHDRAWAL BY
SUBJECT Patient withdrew after motorcycle accident
(Undisclosed medical condition)
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Page 30
FDA-CBER-2022-5812-0223806
16.2.1.1.1 Listing of Subjects Discontinued From Vaccination and/or From the Study –
Subjects 12 Through 25 Years of Ag e
Age
Group
(Years) Subject Dose
No. Rel
Daya Withdrawal
Date Study Phase Withdrawal Reason Commentb
2 10 30OCT2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT Patient withdrew after motorcycle accident
(Undisclosed medical condition)
C4591001
1248
12481025
29AUG2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT Subject Withdrew Consent
C4591001
1248
12481046 1 66 04NOV2020 VACCINATION LOST TO FOLLOW -UP Missed V2 on 20Sep2020; site has been unable to
contact subject despite multiple calls.
1 66 04NOV2020 FOLLOW -UP LOST TO FOLLOW -UP Please see EOT page
C4591001
1248
12481110 1 59 06NOV2020 VACCINATION LOST TO FOLLOW -UP Subject was no show for V2; unable to contact
subject.
1 59 06NOV2020 FOLLOW -UP LOST TO FOLLOW -UP Subject was no show for V2; unable to contact
subject.
C4591001
1248
12481138 2 125 02FEB2021 FOLLOW -UP WITHDRAWAL BY
SUBJECT Subject said she no longer wishes to participate in the
study. No reason given.
C4591001
1248
12481206 2 1 09OCT2020 VACCINATION LOST TO FOLLOW -UP Lost to follow up
2 1 09OCT2020 FOLLOW -UP LOST TO FOLLO W-UP Lost to follow up
C4591001
1254
12541142 1 26 07OCT2020 VACCINATION PREGNANCY PREGNANCY/MATERNAL EXPOSURE DURING
PREGNANCY
C4591001
1258
12581069 2 55 04JAN2021 VACCINATION WITHDRAWAL BY
SUBJECT subject moved and withdrew consent
2 55 04JAN2021 FOLLOW -UP WITHDRAWAL BY
SUBJECT subject moved and withdrew consent
090177e196ac9156\Final\Final On: 31-Mar-2021 13:05 (GMT)
Page 31
FDA-CBER-2022-5812-0223807
16.2.1.1.1 Listing of Subjects Discontinued From Vaccination and/or From the Study –
Subjects 12 Through 25 Years of Ag e
Age
Group
(Years) Subject Dose
No. Rel
Daya Withdrawal
Date Study Phase Withdrawal Reason Commentb
C4591001
1269
12691047 2 126 18JAN2021 FOLLOW -UP WITHDRAWAL BY
SUBJECT Subject discontinued her participation
C4591001
1270
12701175 2 66 24FEB2021 VACCINATION WITHDRAWAL BY
SUBJECT Per LAR/father, request to drop participant, non -
compliant with study activities
2 66 24FEB2021 FOLLOW -UP WITHDRAWAL BY
SUBJECT Per LAR/father request to drop participant as has
been non -compliant with study activities
C4591001
1270
12701176 2 66 24FEB2021 VACCINATION WITHDRAWAL BY
SUBJECT Per LAR/father, request to drop participant, non -
compliant with study activities
2 66 24FEB2021 FOLLOW -UP WITHDRAWAL BY
SUBJECT Per LAR/father, request to drop participant as
participant is non -compliant with study activities
C4591001
4444
44441329 2 81 31DEC2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT the decision to stop participating is due to personal
issues.
C4591001
4444
44442006 2 140 02MAR2021 FOLLOW -UP WITHDRAWAL BY
SUBJECT the decision to stop participating is for personal
reasons
C4591001
4444
44442081 2 145 08MAR2021 FOLLOW -UP WITHDRAWA L BY
SUBJECT the decision is due to "the little collaboration of Pfizer
with the Argentine State."
C4591001
4444
44442263 1 24 20OCT2020 VACCINATION WITHDRAWAL BY
SUBJECT Will not be able to continue in the trial since she has
had to travel abroad for personal reasons
1 24 20OCT2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT Will not be able to continue in the trial since she has
had to travel abroad for personal reasons
a. Relative day (Rel Day) = date of withdrawal - date of last vaccination + 1. For a withdrawal that occurred before the date of the first study
vaccination, + 1 was not added to compute relative day.
090177e196ac9156\Final\Final On: 31-Mar-2021 13:05 (GMT)
Page 32
FDA-CBER-2022-5812-0223808
16.2.1.1.1 Listing of Subjects Discontinued From Vaccination and/or From the Study –
Subjects 12 Through 25 Years of Ag e
Age
Group
(Years) Subject Dose
No. Rel
Daya Withdrawal
Date Study Phase Withdrawal Reason Commentb
b. MedDRA (v23.1) coding dictionary applied.
PFIZER CONFIDENTIAL SDTM Creation: 25MAR2021 (19:20) Source Data: adds Table Generation: 27MAR2021 (00:55)
(Cutoff Date: 13MAR2021, Snapshot Date: 25MAR2021) Output File: ./nda2_unblinded/C4591001_BLA/adds_l001_withdraw_ped
090177e196ac9156\Final\Final On: 31-Mar-2021 13:05 (GMT)
Page 33
FDA-CBER-2022-5812-0223809