125742 45 S211 M5 c4591001 interim ado efficacy response sensitive
Document text
16.2.6.1 Listing of Assay Data – Subjects 12 Through 25 Years o f Age
Age Group (Years) Vaccine Group
(as Randomized) Subject Dose/
Sampling
Time Point Date of
Sample Rel
DayaNT50
(Titer)
12-15 BNT162b2 (30 μg) C4591001 1005 10051328 2/1 Month 11DEC2020 31 1938
C4591001 1005 10051412 1/Prevax 14DEC2020 1 10
2/1 Month 09FEB2021 36 1192
C4591001 1006 10061184 1/Prevax 30NOV2020 1 10
2/1 Month 22JAN2021 33 1838
C4591001 1006 10061209 1/Prevax 04DEC2020 1 273
2/1 Month 26JAN2021 35 3923
C4591001 1006 10061220 1/Prevax 07DEC2020 1 10
C4591001 1006 10061227 1/Prevax 07DEC2020 1 10
C4591001 1006 10061230 2/1 Month 02FEB2021 34 720
C4591001 1006 10061231 2/1 Month 26JAN2021 30 2203
C4591001 1006 10061234 2/1 Month 27JAN2021 29 926
C4591001 1006 10061249 1/Prevax 11DEC2020 1 10
2/1 Month 04FEB2021 36 2017
C4591001 1006 10061256 1/Prevax 11DEC2020 1 10
2/1 Month 01FEB2021 34 648
C4591001 1006 10061261 1/Prevax 14DEC2020 1 10
C4591001 1006 10061263 2/1 Month 05FEB2021 33 2026
C4591001 1006 10061265 1/Prevax 18DEC2020 1 10
2/1 Month 04FEB2021 30 1578
C4591001 1006 10061274 1/Prevax 16DEC2020 1 10
2/1 Month 05FEB2021 29 3332
C4591001 1006 10061280 1/Prevax 17DEC2020 1 10
C4591001 1006 10061282 1/Prevax 18DEC2020 1 10
C4591001 1007 10071417 1/Prevax 22OCT2020 1 10
2/1 Month 10DEC2020 29 1629
C4591001 1007 10071467 1/Prevax 30NOV2020 1 10
090177e196ac9128\Final\Final On: 31-Mar-2021 13:00 (GMT)
Page 1
FDA-CBER-2022-5812-0223810
16.2.6.1 Listing of Assay Data – Subjects 12 Through 25 Years o f Age
Age Group (Years) Vaccine Group
(as Randomized) Subject Dose/
Sampling
Time Point Date of
Sample Rel
DayaNT50
(Titer)
C4591001 1007 10071469 1/Prevax 30NOV2020 1 10
2/1 Month 20JAN2021 31 7683
C4591001 1007 10071471 1/Prevax 30NOV2020 1 10
C4591001 1007 10071488 1/Prevax 01DEC2020 1 10
2/1 Month 20JAN2021 30 889
C4591001 1007 10071494 2/1 Month 20JAN2021 31 620
C4591001 1007 10071504 1/Prevax 07DEC2020 1 10
2/1 Month 27JAN2021 29 2079
C4591001 1007 10071506 1/Prevax 07DEC2020 1 10
2/1 Month 25JAN2021 29 1099
C4591001 1007 10071512 1/Prevax 07DEC2020 1 10
2/1 Month 25JAN2021 29 1171
C4591001 1007 10071517 1/Prevax 08DEC2020 1 10
2/1 Month 26JAN2021 29 789
C4591001 1007 10071521 1/Prevax 08DEC2020 1 10
2/1 Month 28JAN2021 31 1130
C4591001 1007 10071523 1/Prevax 08DEC2020 1 10
C4591001 1007 10071525 1/Prevax 08DEC2020 1 10
2/1 Month 03FEB2021 37 1484
C4591001 1007 10071526 2/1 Month 26JAN2021 29 1876
C4591001 1007 10071529 1/Prevax 09DEC2020 1 10
2/1 Month 27JAN2021 29 1542
C4591001 1007 10071536 1/Prevax 09DEC2020 1 10
2/1 Month 26JAN2021 29 921
C4591001 1007 10071537 1/Prevax 09DEC2020 1 10
2/1 Month 27JAN2021 29 1326
C4591001 1007 10071546 1/Prevax 10DEC2020 1 10
090177e196ac9128\Final\Final On: 31-Mar-2021 13:00 (GMT)
Page 2
FDA-CBER-2022-5812-0223811
16.2.6.1 Listing of Assay Data – Subjects 12 Through 25 Years o f Age
Age Group (Years) Vaccine Group
(as Randomized) Subject Dose/
Sampling
Time Point Date of
Sample Rel
DayaNT50
(Titer)
2/1 Month 27JAN2021 29 1604
C4591001 1007 10071550 1/Prevax 10DEC2020 1 10
2/1 Month 28JAN2021 30 2537
C4591001 1007 10071555 1/Prevax 10DEC2020 1 10
2/1 Month 26JAN2021 29 832
C4591001 1007 10071558 1/Prevax 14DEC2020 1 10
2/1 Month 03FEB2021 31 3867
C4591001 1007 10071561 1/Prevax 14DEC2020 1 10
2/1 Month 02FEB2021 30 1933
C4591001 1007 10071564 1/Prevax 14DEC2020 1 55
2/1 Month 08FEB2021 34 1282
C4591001 1007 10071567 1/Prevax 15DEC2020 1 10
2/1 Month 02FEB2021 29 782
C4591001 1007 10071574 1/Prevax 16DEC2020 1 10
C4591001 1007 10071575 1/Prevax 16DEC2020 1 10
2/1 Month 03FEB2021 29 1136
C4591001 1007 10071579 1/Prevax 16DEC2020 1 10
2/1 Month 08FEB2021 34 1369
C4591001 1007 10071580 1/Prevax 16DEC2020 1 10
2/1 Month 04FEB2021 30 1929
C4591001 1007 10071587 1/Prevax 17DEC2020 1 10
2/1 Month 04FEB2021 29 497
C4591001 1008 10081754 2/1 Month 22JAN2021 32 1607
C4591001 1008 10081760 1/Prevax 07DEC2020 1 10
2/1 Month 26JAN2021 30 866
C4591001 1008 10081764 1/Prevax 07DEC2020 1 10
C4591001 1008 10081770 1/Prevax 09DEC2020 1 33
090177e196ac9128\Final\Final On: 31-Mar-2021 13:00 (GMT)
Page 3
FDA-CBER-2022-5812-0223812
16.2.6.1 Listing of Assay Data – Subjects 12 Through 25 Years o f Age
Age Group (Years) Vaccine Group
(as Randomized) Subject Dose/
Sampling
Time Point Date of
Sample Rel
DayaNT50
(Titer)
2/1 Month 27JAN2021 29 2342
C4591001 1008 10081792 1/Prevax 14DEC2020 1 10
2/1 Month 01FEB2021 29 865
C4591001 1008 10081795 1/Prevax 15DEC2020 1 10
2/1 Month 04FEB2021 29 2195
C4591001 1008 10081797 2/1 Month 03FEB2021 30 908
C4591001 1008 10081800 1/Prevax 16DEC2020 1 10
C4591001 1008 10081802 1/Prevax 17DEC2020 1 10
2/1 Month 04FEB2021 29 745
C4591001 1008 10081805 1/Prevax 17DEC2020 1 10
2/1 Month 05FEB2021 30 2637
C4591001 1008 10081810 1/Prevax 18DEC2020 1 10
2/1 Month 05FEB2021 29 2211
C4591001 1008 10081813 1/Prevax 18DEC2020 1 10
2/1 Month 08FEB2021 32 5462
C4591001 1008 10081814 1/Prevax 18DEC2020 1 10
2/1 Month 05FEB2021 29 1285
C4591001 1008 10081818 1/Prevax 18DEC2020 1 10
2/1 Month 05FEB2021 29 1683
C4591001 1009 10091205 1/Prevax 15OCT2020 1 10
2/1 Month 04DEC2020 29 726
C4591001 1009 10091221 1/Prevax 19OCT2020 1 10
C4591001 1009 10091234 1/Prevax 21OCT2020 1 10
2/1 Month 16DEC2020 36 5924
C4591001 1009 10091250 2/1 Month 11DEC2020 29 1157
C4591001 1009 10091265 1/Prevax 01DEC2020 1 10
C4591001 1009 10091270 1/Prevax 01DEC2020 1 10
090177e196ac9128\Final\Final On: 31-Mar-2021 13:00 (GMT)
Page 4
FDA-CBER-2022-5812-0223813
16.2.6.1 Listing of Assay Data – Subjects 12 Through 25 Years o f Age
Age Group (Years) Vaccine Group
(as Randomized) Subject Dose/
Sampling
Time Point Date of
Sample Rel
DayaNT50
(Titer)
2/1 Month 20JAN2021 29 1373
C4591001 1009 10091272 1/Prevax 02DEC2020 1 10
2/1 Month 19JAN2021 29 1021
C4591001 1009 10091280 1/Prevax 03DEC2020 1 10
C4591001 1009 10091281 1/Prevax 03DEC2020 1 10
C4591001 1009 10091284 2/1 Month 27JAN2021 36 500
C4591001 1009 10091298 2/1 Month 25JAN2021 29 1087
C4591001 1009 10091310 1/Prevax 09DEC2020 1 10
2/1 Month 01FEB2021 35 1450
C4591001 1009 10091313 1/Prevax 09DEC2020 1 10
2/1 Month 02FEB2021 36 719
C4591001 1009 10091315 1/Prevax 09DEC2020 1 10
2/1 Month 29JAN2021 33 1998
C4591001 1009 10091318 1/Prevax 10DEC2020 1 10
2/1 Month 27JAN2021 30 1173
C4591001 1009 10091319 1/Prevax 10DEC2020 1 10
2/1 Month 02FEB2021 36 735
C4591001 1009 10091321 1/Prevax 10DEC2020 1 10
2/1 Month 29JAN2021 31 1745
C4591001 1009 10091322 1/Prevax 10DEC2020 1 10
2/1 Month 28JAN2021 30 1683
C4591001 1009 10091331 1/Prevax 11DEC2020 1 10
2/1 Month 29JAN2021 31 1549
C4591001 1009 10091332 1/Prevax 11DEC2020 1 10
2/1 Month 29JAN2021 31 1345
C4591001 1009 10091335 1/Prevax 11DEC2020 1 10
2/1 Month 29JAN2021 30 911
090177e196ac9128\Final\Final On: 31-Mar-2021 13:00 (GMT)
Page 5
FDA-CBER-2022-5812-0223814
16.2.6.1 Listing of Assay Data – Subjects 12 Through 25 Years o f Age
Age Group (Years) Vaccine Group
(as Randomized) Subject Dose/
Sampling
Time Point Date of
Sample Rel
DayaNT50
(Titer)
C4591001 1009 10091342 2/1 Month 05FEB2021 33 860
C4591001 1009 10091348 1/Prevax 15DEC2020 1 10
2/1 Month 05FEB2021 31 666
C4591001 1009 10091351 1/Prevax 16DEC2020 1 10
2/1 Month 03FEB2021 29 905
C4591001 1009 10091354 1/Prevax 16DEC2020 1 10
C4591001 1009 10091355 1/Prevax 16DEC2020 1 10
2/1 Month 11FEB2021 35 2648
C4591001 1009 10091358 1/Prevax 17DEC2020 1 10
2/1 Month 05FEB2021 31 6771
C4591001 1009 10091360 1/Prevax 17DEC2020 1 10
2/1 Month 03FEB2021 29 1416
C4591001 1009 10091362 1/Prevax 17DEC2020 1 10
2/1 Month 08FEB2021 29 1543
C4591001 1009 10091364 2/1 Month 16FEB2021 29 2056
C4591001 1013 10131822 1/Prevax 30NOV2020 1 10
C4591001 1013 10131828 1/Prevax 02DEC2020 1 10
C4591001 1013 10131836 1/Prevax 02DEC2020 1 10
2/1 Month 19JAN2021 29 1012
C4591001 1013 10131843 2/1 Month 27JAN2021 37 1034
C4591001 1013 10131845 1/Prevax 03DEC2020 1 10
2/1 Month 21JAN2021 30 1471
C4591001 1013 10131850 1/Prevax 03DEC2020 1 10
C4591001 1013 10131855 1/Prevax 08DEC2020 1 10
C4591001 1016 10161325 1/Prevax 19OCT2020 1 10
2/1 Month 08DEC2020 29 10
C4591001 1016 10161332 1/Prevax 21OCT2020 1 10
090177e196ac9128\Final\Final On: 31-Mar-2021 13:00 (GMT)
Page 6
FDA-CBER-2022-5812-0223815
16.2.6.1 Listing of Assay Data – Subjects 12 Through 25 Years o f Age
Age Group (Years) Vaccine Group
(as Randomized) Subject Dose/
Sampling
Time Point Date of
Sample Rel
DayaNT50
(Titer)
2/1 Month 07DEC2020 29 1328
C4591001 1016 10161339 1/Prevax 22OCT2020 1 10
2/1 Month 09DEC2020 30 1677
C4591001 1016 10161350 1/Prevax 30NOV2020 1 10
2/1 Month 18JAN2021 29 1128
C4591001 1016 10161356 1/Prevax 02DEC2020 1 10
C4591001 1016 10161362 1/Prevax 04DEC2020 1 103
2/1 Month 26JAN2021 30 4809
C4591001 1016 10161363 1/Prevax 08DEC2020 1 130
2/1 Month 26JAN2021 30 5530
C4591001 1016 10161364 1/Prevax 09DEC2020 1 10
2/1 Month 04FEB2021 36 1330
C4591001 1039 10391247 1/Prevax 01DEC2020 1 10
2/1 Month 19JAN2021 30 1541
C4591001 1039 10391255 1/Prevax 07DEC2020 1 10
2/1 Month 27JAN2021 30 2905
C4591001 1039 10391272 1/Prevax 09DEC2020 1 10
2/1 Month 25JAN2021 29 664
C4591001 1039 10391276 1/Prevax 16DEC2020 1 10
2/1 Month 05FEB2021 32 1472
C4591001 1039 10391281 1/Prevax 17DEC2020 1 10
2/1 Month 02FEB2021 29 551
C4591001 1039 10391282 1/Prevax 18DEC2020 1 10
2/1 Month 05FEB2021 29 1197
C4591001 1039 10391284 1/Prevax 18DEC2020 1 10
2/1 Month 04FEB2021 29 1202
C4591001 1039 10391286 1/Prevax 18DEC2020 1 10
090177e196ac9128\Final\Final On: 31-Mar-2021 13:00 (GMT)
Page 7
FDA-CBER-2022-5812-0223816
16.2.6.1 Listing of Assay Data – Subjects 12 Through 25 Years o f Age
Age Group (Years) Vaccine Group
(as Randomized) Subject Dose/
Sampling
Time Point Date of
Sample Rel
DayaNT50
(Titer)
2/1 Month 05FEB2021 29 776
C4591001 1044 10441255 1/Prevax 01DEC2020 1 10
2/1 Month 18JAN2021 29 4251
C4591001 1044 10441263 1/Prevax 07DEC2020 1 10
2/1 Month 25JAN2021 29 2680
C4591001 1044 10441268 1/Prevax 08DEC2020 1 776
2/1 Month 25JAN2021 29 962
C4591001 1044 10441276 1/Prevax 09DEC2020 1 10
2/1 Month 25JAN2021 28 1606
C4591001 1044 10441278 1/Prevax 09DEC2020 1 10
2/1 Month 27JAN2021 30 1422
C4591001 1044 10441285 1/Prevax 10DEC2020 1 10
2/1 Month 29JAN2021 31 1519
C4591001 1044 10441291 1/Prevax 17DEC2020 1 10
2/1 Month 03FEB2021 29 682
C4591001 1044 10441295 1/Prevax 18DEC2020 1 10
C4591001 1057 10571378 1/Prevax 07DEC2020 1 10
C4591001 1057 10571395 1/Prevax 09DEC2020 1 10
2/1 Month 17FEB2021 35 849
C4591001 1057 10571403 2/1 Month 02FEB2021 30 5402
C4591001 1057 10571409 1/Prevax 17DEC2020 1 10
C4591001 1057 10571412 1/Prevax 17DEC2020 1 210
C4591001 1066 10661395 2/1 Month 19JAN2021 30 743
C4591001 1066 10661402 1/Prevax 02DEC2020 1 10
2/1 Month 20JAN2021 31 1805
C4591001 1066 10661408 1/Prevax 08DEC2020 1 15
C4591001 1066 10661409 2/1 Month 26JAN2021 30 2477
090177e196ac9128\Final\Final On: 31-Mar-2021 13:00 (GMT)
Page 8
FDA-CBER-2022-5812-0223817
16.2.6.1 Listing of Assay Data – Subjects 12 Through 25 Years o f Age
Age Group (Years) Vaccine Group
(as Randomized) Subject Dose/
Sampling
Time Point Date of
Sample Rel
DayaNT50
(Titer)
C4591001 1066 10661420 1/Prevax 17DEC2020 1 10
2/1 Month 03FEB2021 30 2029
C4591001 1077 10771274 1/Prevax 03DEC2020 1 10
C4591001 1077 10771279 2/1 Month 02FEB2021 30 10
C4591001 1077 10771284 1/Prevax 15DEC2020 1 10
2/1 Month 03FEB2021 29 10
C4591001 1077 10771292 2/1 Month 10FEB2021 36 841
C4591001 1084 10841546 1/Prevax 18DEC2020 1 10
2/1 Month 05FEB2021 31 906
C4591001 1091 10911394 1/Prevax 02DEC2020 1 10
2/1 Month 20JAN2021 31 1322
C4591001 1091 10911395 2/1 Month 20JAN2021 31 1142
C4591001 1091 10911399 1/Prevax 04DEC2020 1 10
2/1 Month 04FEB2021 29 3079
C4591001 1091 10911413 1/Prevax 09DEC2020 1 10
C4591001 1091 10911416 1/Prevax 10DEC2020 1 10
2/1 Month 27JAN2021 29 3214
C4591001 1091 10911420 2/1 Month 27JAN2021 29 1278
C4591001 1091 10911436 2/1 Month 04FEB2021 30 910
C4591001 1091 10911440 2/1 Month 08FEB2021 32 986
C4591001 1123 11231439 1/Prevax 08DEC2020 1 10
C4591001 1123 11231446 1/Prevax 09DEC2020 1 10
2/1 Month 27JAN2021 29 890
C4591001 1123 11231447 2/1 Month 01FEB2021 35 900
C4591001 1123 11231455 2/1 Month 02FEB2021 30 1196
C4591001 1123 11231458 1/Prevax 16DEC2020 1 10
2/1 Month 01FEB2021 29 1312
090177e196ac9128\Final\Final On: 31-Mar-2021 13:00 (GMT)
Page 9
FDA-CBER-2022-5812-0223818
16.2.6.1 Listing of Assay Data – Subjects 12 Through 25 Years o f Age
Age Group (Years) Vaccine Group
(as Randomized) Subject Dose/
Sampling
Time Point Date of
Sample Rel
DayaNT50
(Titer)
C4591001 1123 11231459 1/Prevax 16DEC2020 1 10
2/1 Month 01FEB2021 29 1319
C4591001 1124 11241238 1/Prevax 14DEC2020 1 10
2/1 Month 03FEB2021 29 1576
C4591001 1124 11241239 1/Prevax 14DEC2020 1 10
2/1 Month 03FEB2021 29 1779
C4591001 1124 11241243 2/1 Month 09FEB2021 36 2127
C4591001 1124 11241249 1/Prevax 16DEC2020 1 10
C4591001 1124 11241251 1/Prevax 18DEC2020 1 10
2/1 Month 05FEB2021 29 7898
C4591001 1124 11241254 2/1 Month 10FEB2021 34 1423
C4591001 1126 11261229 1/Prevax 30NOV2020 1 10
2/1 Month 18JAN2021 29 1085
C4591001 1126 11261241 1/Prevax 02DEC2020 1 10
2/1 Month 20JAN2021 31 823
C4591001 1126 11261243 2/1 Month 22JAN2021 33 1754
C4591001 1126 11261246 1/Prevax 02DEC2020 1 10
2/1 Month 20JAN2021 29 969
C4591001 1126 11261255 1/Prevax 03DEC2020 1 10
2/1 Month 26JAN2021 35 2453
C4591001 1126 11261269 1/Prevax 14DEC2020 1 10
C4591001 1126 11261273 1/Prevax 14DEC2020 1 10
C4591001 1126 11261277 1/Prevax 15DEC2020 1 10
C4591001 1126 11261278 2/1 Month 02FEB2021 29 373
C4591001 1126 11261281 1/Prevax 16DEC2020 1 10
2/1 Month 12FEB2021 37 1681
C4591001 1126 11261285 1/Prevax 16DEC2020 1 10
090177e196ac9128\Final\Final On: 31-Mar-2021 13:00 (GMT)
Page 10
FDA-CBER-2022-5812-0223819
16.2.6.1 Listing of Assay Data – Subjects 12 Through 25 Years o f Age
Age Group (Years) Vaccine Group
(as Randomized) Subject Dose/
Sampling
Time Point Date of
Sample Rel
DayaNT50
(Titer)
2/1 Month 03FEB2021 29 727
C4591001 1126 11261291 1/Prevax 17DEC2020 1 10
2/1 Month 04FEB2021 29 569
C4591001 1126 11261293 1/Prevax 18DEC2020 1 10
2/1 Month 05FEB2021 29 1419
C4591001 1131 11311275 1/Prevax 04DEC2020 1 10
C4591001 1131 11311278 1/Prevax 08DEC2020 1 10
2/1 Month 27JAN2021 29 1209
C4591001 1139 11391144 1/Prevax 11DEC2020 1 10
2/1 Month 27JAN2021 29 1152
C4591001 1139 11391145 1/Prevax 01DEC2020 1 10
2/1 Month 19JAN2021 30 718
C4591001 1139 11391151 1/Prevax 04DEC2020 1 14
C4591001 1139 11391155 1/Prevax 04DEC2020 1 10
2/1 Month 29JAN2021 33 2762
C4591001 1139 11391156 1/Prevax 07DEC2020 1 10
C4591001 1139 11391161 1/Prevax 08DEC2020 1 10
2/1 Month 01FEB2021 35 1041
C4591001 1139 11391162 1/Prevax 08DEC2020 1 10
2/1 Month 01FEB2021 35 788
C4591001 1139 11391165 2/1 Month 03FEB2021 36 542
C4591001 1139 11391178 1/Prevax 18DEC2020 1 10
2/1 Month 05FEB2021 29 464
C4591001 1139 11391179 1/Prevax 18DEC2020 1 10
2/1 Month 05FEB2021 29 573
C4591001 1140 11401328 1/Prevax 14DEC2020 1 10
2/1 Month 05FEB2021 32 884
090177e196ac9128\Final\Final On: 31-Mar-2021 13:00 (GMT)
Page 11
FDA-CBER-2022-5812-0223820
16.2.6.1 Listing of Assay Data – Subjects 12 Through 25 Years o f Age
Age Group (Years) Vaccine Group
(as Randomized) Subject Dose/
Sampling
Time Point Date of
Sample Rel
DayaNT50
(Titer)
C4591001 1140 11401332 1/Prevax 16DEC2020 1 10
2/1 Month 03FEB2021 29 2191
C4591001 1140 11401336 1/Prevax 17DEC2020 1 10
C4591001 1140 11401337 1/Prevax 17DEC2020 1 10
C4591001 1142 11421319 1/Prevax 01DEC2020 1 10
C4591001 1142 11421330 1/Prevax 04DEC2020 1 10
C4591001 1142 11421343 1/Prevax 08DEC2020 1 10
C4591001 1142 11421346 2/1 Month 27JAN2021 30 1553
C4591001 1142 11421350 2/1 Month 02FEB2021 35 2271
C4591001 1142 11421353 2/1 Month 29JAN2021 30 1365
C4591001 1142 11421360 2/1 Month 01FEB2021 29 1463
C4591001 1142 11421362 2/1 Month 02FEB2021 30 1149
C4591001 1147 11471262 1/Prevax 12DEC2020 1 10
2/1 Month 06FEB2021 34 786
C4591001 1147 11471268 1/Prevax 05DEC2020 1 10
2/1 Month 30JAN2021 34 5724
C4591001 1147 11471277 1/Prevax 08DEC2020 1 10
2/1 Month 30JAN2021 34 3085
C4591001 1147 11471279 2/1 Month 30JAN2021 34 1586
C4591001 1147 11471282 1/Prevax 12DEC2020 1 10
2/1 Month 08FEB2021 36 2460
C4591001 1150 11501118 1/Prevax 15OCT2020 1 10
2/1 Month 02DEC2020 30 7031
C4591001 1150 11501119 1/Prevax 15OCT2020 1 10
C4591001 1150 11501127 1/Prevax 19OCT2020 1 10
2/1 Month 09DEC2020 29 773
C4591001 1150 11501130 1/Prevax 20OCT2020 1 110
090177e196ac9128\Final\Final On: 31-Mar-2021 13:00 (GMT)
Page 12
FDA-CBER-2022-5812-0223821
16.2.6.1 Listing of Assay Data – Subjects 12 Through 25 Years o f Age
Age Group (Years) Vaccine Group
(as Randomized) Subject Dose/
Sampling
Time Point Date of
Sample Rel
DayaNT50
(Titer)
2/1 Month 11DEC2020 33 5987
C4591001 1150 11501132 1/Prevax 20OCT2020 1 10
2/1 Month 11DEC2020 33 2148
C4591001 1150 11501133 1/Prevax 21OCT2020 1 10
2/1 Month 08DEC2020 29 3119
C4591001 1150 11501180 1/Prevax 08DEC2020 1 10
2/1 Month 27JAN2021 29 849
C4591001 1150 11501186 1/Prevax 09DEC2020 1 10
2/1 Month 26JAN2021 29 985
C4591001 1150 11501187 1/Prevax 09DEC2020 1 10
2/1 Month 26JAN2021 30 1582
C4591001 1150 11501191 1/Prevax 10DEC2020 1 10
2/1 Month 27JAN2021 29 2704
C4591001 1150 11501194 1/Prevax 10DEC2020 1 10
2/1 Month 02FEB2021 34 534
C4591001 1150 11501197 1/Prevax 11DEC2020 1 10
2/1 Month 28JAN2021 30 1129
C4591001 1150 11501208 1/Prevax 14DEC2020 1 10
2/1 Month 01FEB2021 29 2309
C4591001 1150 11501211 1/Prevax 15DEC2020 1 10
2/1 Month 04FEB2021 29 445
C4591001 1150 11501216 1/Prevax 16DEC2020 1 10
2/1 Month 03FEB2021 29 1142
C4591001 1150 11501217 1/Prevax 16DEC2020 1 10
2/1 Month 03FEB2021 30 4893
C4591001 1150 11501221 1/Prevax 17DEC2020 1 10
2/1 Month 12FEB2021 36 262
090177e196ac9128\Final\Final On: 31-Mar-2021 13:00 (GMT)
Page 13
FDA-CBER-2022-5812-0223822
16.2.6.1 Listing of Assay Data – Subjects 12 Through 25 Years o f Age
Age Group (Years) Vaccine Group
(as Randomized) Subject Dose/
Sampling
Time Point Date of
Sample Rel
DayaNT50
(Titer)
C4591001 1150 11501226 1/Prevax 17DEC2020 1 10
2/1 Month 08FEB2021 32 1910
C4591001 1150 11501227 2/1 Month 08FEB2021 34 974
C4591001 1152 11521605 1/Prevax 02DEC2020 1 10
2/1 Month 19JAN2021 29 2146
C4591001 1152 11521614 1/Prevax 03DEC2020 1 10
2/1 Month 19JAN2021 29 1241
C4591001 1152 11521619 1/Prevax 03DEC2020 1 10
2/1 Month 25JAN2021 35 1721
C4591001 1152 11521625 1/Prevax 04DEC2020 1 10
C4591001 1152 11521635 2/1 Month 25JAN2021 29 1164
C4591001 1152 11521636 2/1 Month 25JAN2021 29 1086
C4591001 1152 11521648 2/1 Month 28JAN2021 32 1471
C4591001 1152 11521650 1/Prevax 08DEC2020 1 10
2/1 Month 25JAN2021 29 836
C4591001 1152 11521655 1/Prevax 09DEC2020 1 10
2/1 Month 26JAN2021 29 550
C4591001 1152 11521656 1/Prevax 10DEC2020 1 10
C4591001 1152 11521657 1/Prevax 10DEC2020 1 10
C4591001 1152 11521671 2/1 Month 01FEB2021 29 2569
C4591001 1152 11521674 2/1 Month 08FEB2021 32 866
C4591001 1152 11521677 1/Prevax 15DEC2020 1 10
2/1 Month 01FEB2021 29 3484
C4591001 1152 11521679 1/Prevax 15DEC2020 1 19
C4591001 1152 11521689 1/Prevax 16DEC2020 1 10
C4591001 1152 11521692 1/Prevax 16DEC2020 1 10
2/1 Month 08FEB2021 34 1820
090177e196ac9128\Final\Final On: 31-Mar-2021 13:00 (GMT)
Page 14
FDA-CBER-2022-5812-0223823
16.2.6.1 Listing of Assay Data – Subjects 12 Through 25 Years o f Age
Age Group (Years) Vaccine Group
(as Randomized) Subject Dose/
Sampling
Time Point Date of
Sample Rel
DayaNT50
(Titer)
C4591001 1152 11521694 1/Prevax 16DEC2020 1 10
2/1 Month 03FEB2021 29 1327
C4591001 1152 11521697 1/Prevax 18DEC2020 1 10
C4591001 1152 11521699 2/1 Month 10FEB2021 34 1710
C4591001 1156 11561243 1/Prevax 15OCT2020 1 10
2/1 Month 02DEC2020 30 315
C4591001 1156 11561245 1/Prevax 15OCT2020 1 10
2/1 Month 02DEC2020 30 862
C4591001 1156 11561249 1/Prevax 16OCT2020 1 10
2/1 Month 03DEC2020 30 887
C4591001 1156 11561250 1/Prevax 16OCT2020 1 10
2/1 Month 02DEC2020 29 115
C4591001 1156 11561257 1/Prevax 20OCT2020 1 10
C4591001 1156 11561259 1/Prevax 20OCT2020 1 10
2/1 Month 09DEC2020 30 894
C4591001 1156 11561264 2/1 Month 14DEC2020 35 1483
C4591001 1156 11561304 1/Prevax 30NOV2020 1 10
C4591001 1156 11561310 1/Prevax 01DEC2020 1 10
2/1 Month 05FEB2021 30 1842
C4591001 1156 11561313 2/1 Month 20JAN2021 31 1231
C4591001 1156 11561314 2/1 Month 22JAN2021 31 3575
C4591001 1156 11561317 2/1 Month 26JAN2021 30 1194
C4591001 1156 11561321 1/Prevax 07DEC2020 1 10
C4591001 1156 11561324 1/Prevax 07DEC2020 1 10
C4591001 1235 12351233 2/1 Month 19JAN2021 30 877
C4591001 1235 12351242 2/1 Month 28JAN2021 32 1058
C4591001 1235 12351245 1/Prevax 08DEC2020 1 10
090177e196ac9128\Final\Final On: 31-Mar-2021 13:00 (GMT)
Page 15
FDA-CBER-2022-5812-0223824
16.2.6.1 Listing of Assay Data – Subjects 12 Through 25 Years o f Age
Age Group (Years) Vaccine Group
(as Randomized) Subject Dose/
Sampling
Time Point Date of
Sample Rel
DayaNT50
(Titer)
2/1 Month 29JAN2021 31 1364
C4591001 1235 12351246 1/Prevax 15DEC2020 1 10
C4591001 1235 12351250 2/1 Month 02FEB2021 29 1385
C4591001 1270 12701184 1/Prevax 02DEC2020 1 10
2/1 Month 20JAN2021 29 1735
C4591001 1270 12701187 1/Prevax 03DEC2020 1 10
C4591001 1270 12701200 1/Prevax 10DEC2020 1 10
2/1 Month 27JAN2021 30 2018
C4591001 1270 12701210 1/Prevax 16DEC2020 1 10
2/1 Month 03FEB2021 31 647
C4591001 1270 12701214 2/1 Month 09FEB2021 33 1900
C4591001 1270 12701220 2/1 Month 08FEB2021 32 1111
Placebo C4591001 1005 10051419 2/1 Month 01FEB2021 29 10
C4591001 1006 10061212 1/Prevax 04DEC2020 1 10
C4591001 1006 10061248 1/Prevax 11DEC2020 1 10
C4591001 1007 10071481 1/Prevax 01DEC2020 1 10
2/1 Month 20JAN2021 30 10
C4591001 1007 10071541 1/Prevax 09DEC2020 1 10
2/1 Month 28JAN2021 30 10
C4591001 1007 10071560 1/Prevax 14DEC2020 1 10
2/1 Month 02FEB2021 29 10
C4591001 1007 10071562 1/Prevax 14DEC2020 1 251
2/1 Month 01FEB2021 29 285
C4591001 1008 10081808 1/Prevax 18DEC2020 1 10
2/1 Month 12FEB2021 36 10
C4591001 1009 10091233 1/Prevax 21OCT2020 1 10
2/1 Month 14DEC2020 33 10
090177e196ac9128\Final\Final On: 31-Mar-2021 13:00 (GMT)
Page 16
FDA-CBER-2022-5812-0223825
16.2.6.1 Listing of Assay Data – Subjects 12 Through 25 Years o f Age
Age Group (Years) Vaccine Group
(as Randomized) Subject Dose/
Sampling
Time Point Date of
Sample Rel
DayaNT50
(Titer)
C4591001 1009 10091273 1/Prevax 02DEC2020 1 10
2/1 Month 19JAN2021 29 10
C4591001 1009 10091314 1/Prevax 09DEC2020 1 10
2/1 Month 01FEB2021 34 68
C4591001 1009 10091317 2/1 Month 27JAN2021 30 10
C4591001 1009 10091341 2/1 Month 05FEB2021 33 10
C4591001 1013 10131848 1/Prevax 03DEC2020 1 10
2/1 Month 20JAN2021 30 10
C4591001 1013 10131867 1/Prevax 17DEC2020 1 10
2/1 Month 03FEB2021 30 10
C4591001 1016 10161324 1/Prevax 19OCT2020 1 10
2/1 Month 07DEC2020 29 10
C4591001 1016 10161340 1/Prevax 22OCT2020 1 10
2/1 Month 09DEC2020 30 10
C4591001 1016 10161361 1/Prevax 04DEC2020 1 10
2/1 Month 22JAN2021 31 67
C4591001 1039 10391256 1/Prevax 07DEC2020 1 10
2/1 Month 27JAN2021 30 10
C4591001 1044 10441260 1/Prevax 01DEC2020 1 10
2/1 Month 20JAN2021 30 10
C4591001 1057 10571400 1/Prevax 11DEC2020 1 37
C4591001 1066 10661394 2/1 Month 27JAN2021 29 128
C4591001 1066 10661405 2/1 Month 21JAN2021 31 10
C4591001 1091 10911400 1/Prevax 04DEC2020 1 10
2/1 Month 27JAN2021 30 10
C4591001 1091 10911407 1/Prevax 08DEC2020 1 10
2/1 Month 25JAN2021 29 621
090177e196ac9128\Final\Final On: 31-Mar-2021 13:00 (GMT)
Page 17
FDA-CBER-2022-5812-0223826
16.2.6.1 Listing of Assay Data – Subjects 12 Through 25 Years o f Age
Age Group (Years) Vaccine Group
(as Randomized) Subject Dose/
Sampling
Time Point Date of
Sample Rel
DayaNT50
(Titer)
C4591001 1091 10911424 1/Prevax 15DEC2020 1 18
2/1 Month 01FEB2021 29 27
C4591001 1123 11231431 1/Prevax 04DEC2020 1 10
C4591001 1123 11231438 1/Prevax 08DEC2020 1 10
C4591001 1123 11231441 1/Prevax 09DEC2020 1 10
C4591001 1123 11231448 1/Prevax 11DEC2020 1 10
C4591001 1124 11241248 2/1 Month 03FEB2021 29 10
C4591001 1126 11261267 1/Prevax 14DEC2020 1 10
2/1 Month 03FEB2021 31 10
C4591001 1140 11401327 1/Prevax 11DEC2020 1 10
2/1 Month 02FEB2021 29 10
C4591001 1140 11401335 1/Prevax 17DEC2020 1 10
2/1 Month 10FEB2021 36 10
C4591001 1142 11421335 1/Prevax 04DEC2020 1 10
2/1 Month 22JAN2021 31 10
C4591001 1150 11501179 1/Prevax 07DEC2020 1 10
2/1 Month 29JAN2021 33 10
C4591001 1150 11501210 1/Prevax 15DEC2020 1 10
2/1 Month 04FEB2021 29 10
C4591001 1152 11521637 1/Prevax 07DEC2020 1 10
2/1 Month 25JAN2021 29 10
C4591001 1152 11521661 1/Prevax 10DEC2020 1 10
C4591001 1152 11521667 1/Prevax 11DEC2020 1 10
C4591001 1152 11521686 1/Prevax 16DEC2020 1 10
C4591001 1152 11521701 2/1 Month 03FEB2021 29 10
C4591001 1156 11561246 1/Prevax 22OCT2020 1 10
2/1 Month 08DEC2020 29 10
090177e196ac9128\Final\Final On: 31-Mar-2021 13:00 (GMT)
Page 18
FDA-CBER-2022-5812-0223827
16.2.6.1 Listing of Assay Data – Subjects 12 Through 25 Years o f Age
Age Group (Years) Vaccine Group
(as Randomized) Subject Dose/
Sampling
Time Point Date of
Sample Rel
DayaNT50
(Titer)
C4591001 1156 11561311 1/Prevax 02DEC2020 1 10
C4591001 1270 12701173 1/Prevax 30NOV2020 1 10
2/1 Month 18JAN2021 29 10
C4591001 1270 12701174 1/Prevax 30NOV2020 1 10
2/1 Month 18JAN2021 29 10
C4591001 1270 12701218 1/Prevax 17DEC2020 1 10
2/1 Month 05FEB2021 30 10
16-25 BNT162b2 (30 μg) C4591001 1001 10011085 1/Prevax 28JUL2020 1 10
2/1 Month 21SEP2020 34 172
C4591001 1005 10051400 1/Prevax 03NOV2020 1 10
2/1 Month 21DEC2020 29 707
C4591001 1005 10051416 1/Prevax 16DEC2020 1 10
2/1 Month 10FEB2021 36 502
C4591001 1006 10061137 1/Prevax 01SEP2020 1 10
C4591001 1006 10061162 1/Prevax 25SEP2020 1 10
2/1 Month 18NOV2020 34 1223
C4591001 1006 10061170 1/Prevax 05OCT2020 1 10
2/1 Month 25NOV2020 29 1617
C4591001 1006 10061192 2/1 Month 26JAN2021 36 891
C4591001 1006 10061202 1/Prevax 03DEC2020 1 10
2/1 Month 19JAN2021 29 1184
C4591001 1006 10061225 1/Prevax 07DEC2020 1 10
2/1 Month 29JAN2021 33 854
C4591001 1007 10071289 1/Prevax 27AUG2020 1 10
2/1 Month 15OCT2020 29 737
C4591001 1007 10071385 1/Prevax 20OCT2020 1 10
2/1 Month 08DEC2020 29 1033
090177e196ac9128\Final\Final On: 31-Mar-2021 13:00 (GMT)
Page 19
FDA-CBER-2022-5812-0223828
16.2.6.1 Listing of Assay Data – Subjects 12 Through 25 Years o f Age
Age Group (Years) Vaccine Group
(as Randomized) Subject Dose/
Sampling
Time Point Date of
Sample Rel
DayaNT50
(Titer)
C4591001 1007 10071434 1/Prevax 27OCT2020 1 10
C4591001 1007 10071439 2/1 Month 21DEC2020 33 668
C4591001 1007 10071447 1/Prevax 11NOV2020 1 10
C4591001 1007 10071454 1/Prevax 12NOV2020 1 10
C4591001 1007 10071473 1/Prevax 07DEC2020 1 10
C4591001 1008 10081558 2/1 Month 25NOV2020 34 466
C4591001 1008 10081747 2/1 Month 08JAN2021 29 968
C4591001 1009 10091028 1/Prevax 12AUG2020 1 10
2/1 Month 05OCT2020 36 775
C4591001 1009 10091070 1/Prevax 19AUG2020 1 10
2/1 Month 12OCT2020 34 267
C4591001 1009 10091217 1/Prevax 16OCT2020 1 10
2/1 Month 04DEC2020 29 668
C4591001 1009 10091256 2/1 Month 22DEC2020 34 2293
C4591001 1011 10111215 1/Prevax 19OCT2020 1 10
2/1 Month 09DEC2020 29 6340
C4591001 1013 10131002 1/Prevax 28JUL2020 1 10
2/1 Month 14SEP2020 29 1040
C4591001 1013 10131026 1/Prevax 30JUL2020 1 10
2/1 Month 30SEP2020 42 654
C4591001 1013 10131059 1/Prevax 03AUG2020 1 10
2/1 Month 21SEP2020 28 697
C4591001 1013 10131171 1/Prevax 13AUG2020 1 10
2/1 Month 01OCT2020 29 1364
C4591001 1013 10131276 1/Prevax 24AUG2020 1 10
C4591001 1013 10131653 1/Prevax 07OCT2020 1 10
C4591001 1013 10131829 1/Prevax 02DEC2020 1 10
090177e196ac9128\Final\Final On: 31-Mar-2021 13:00 (GMT)
Page 20
FDA-CBER-2022-5812-0223829
16.2.6.1 Listing of Assay Data – Subjects 12 Through 25 Years o f Age
Age Group (Years) Vaccine Group
(as Randomized) Subject Dose/
Sampling
Time Point Date of
Sample Rel
DayaNT50
(Titer)
C4591001 1015 10151081 1/Prevax 21AUG2020 1 10
2/1 Month 09OCT2020 29 256
C4591001 1015 10151150 1/Prevax 31AUG2020 1 10
C4591001 1016 10161010 1/Prevax 30JUL2020 1 10
2/1 Month 22SEP2020 35 461
C4591001 1016 10161028 1/Prevax 03AUG2020 1 10
2/1 Month 06OCT2020 29 982
C4591001 1016 10161284 1/Prevax 11SEP2020 1 10
2/1 Month 29OCT2020 30 483
C4591001 1016 10161288 1/Prevax 17SEP2020 1 17
2/1 Month 05NOV2020 31 1041
C4591001 1016 10161289 1/Prevax 18SEP2020 1 10
2/1 Month 06NOV2020 31 468
C4591001 1016 10161293 1/Prevax 21SEP2020 1 10
2/1 Month 09NOV2020 29 1484
C4591001 1016 10161295 1/Prevax 22SEP2020 1 10
2/1 Month 10NOV2020 29 1716
C4591001 1018 10181007 1/Prevax 29JUL2020 1 10
2/1 Month 23SEP2020 36 511
C4591001 1018 10181194 1/Prevax 20AUG2020 1 10
2/1 Month 19OCT2020 33 844
C4591001 1022 10221112 1/Prevax 02SEP2020 1 10
2/1 Month 22OCT2020 29 1593
C4591001 1028 10281029 1/Prevax 20AUG2020 1 10
2/1 Month 08OCT2020 29 1084
C4591001 1028 10281053 1/Prevax 25AUG2020 1 10
2/1 Month 14OCT2020 29 1673
090177e196ac9128\Final\Final On: 31-Mar-2021 13:00 (GMT)
Page 21
FDA-CBER-2022-5812-0223830
16.2.6.1 Listing of Assay Data – Subjects 12 Through 25 Years o f Age
Age Group (Years) Vaccine Group
(as Randomized) Subject Dose/
Sampling
Time Point Date of
Sample Rel
DayaNT50
(Titer)
C4591001 1030 10301072 1/Prevax 11SEP2020 1 10
2/1 Month 30OCT2020 29 460
C4591001 1038 10381006 1/Prevax 19AUG2020 1 10
2/1 Month 07OCT2020 29 552
C4591001 1042 10421004 1/Prevax 29JUL2020 1 10
2/1 Month 25SEP2020 36 187
C4591001 1042 10421114 1/Prevax 17AUG2020 1 10
2/1 Month 07OCT2020 29 295
C4591001 1044 10441193 1/Prevax 17OCT2020 1 10
2/1 Month 03DEC2020 29 1191
C4591001 1044 10441235 1/Prevax 25NOV2020 1 10
2/1 Month 18JAN2021 33 1599
C4591001 1044 10441241 1/Prevax 23NOV2020 1 10
2/1 Month 13JAN2021 30 1465
C4591001 1044 10441272 1/Prevax 08DEC2020 1 10
2/1 Month 29JAN2021 33 746
C4591001 1046 10461125 1/Prevax 27AUG2020 1 10
2/1 Month 20OCT2020 34 977
C4591001 1046 10461171 1/Prevax 02SEP2020 1 10
2/1 Month 26OCT2020 34 222
C4591001 1046 10461319 1/Prevax 26OCT2020 1 10
2/1 Month 14DEC2020 29 612
C4591001 1046 10461338 1/Prevax 30OCT2020 1 10
2/1 Month 18DEC2020 29 1517
C4591001 1046 10461346 1/Prevax 01DEC2020 1 10
C4591001 1047 10471275 1/Prevax 23SEP2020 1 10
C4591001 1047 10471306 1/Prevax 02OCT2020 1 10
090177e196ac9128\Final\Final On: 31-Mar-2021 13:00 (GMT)
Page 22
FDA-CBER-2022-5812-0223831
16.2.6.1 Listing of Assay Data – Subjects 12 Through 25 Years o f Age
Age Group (Years) Vaccine Group
(as Randomized) Subject Dose/
Sampling
Time Point Date of
Sample Rel
DayaNT50
(Titer)
C4591001 1054 10541007 1/Prevax 19AUG2020 1 10
2/1 Month 06OCT2020 29 658
C4591001 1054 10541090 1/Prevax 01SEP2020 1 10
2/1 Month 20OCT2020 29 905
C4591001 1055 10551021 1/Prevax 11AUG2020 1 10
2/1 Month 29SEP2020 30 858
C4591001 1057 10571044 2/1 Month 07OCT2020 29 164
C4591001 1057 10571217 1/Prevax 21SEP2020 1 10
2/1 Month 07DEC2020 56 273
C4591001 1057 10571234 1/Prevax 23SEP2020 1 10
2/1 Month 11NOV2020 29 264
C4591001 1057 10571366 1/Prevax 23NOV2020 1 10
C4591001 1057 10571368 1/Prevax 23NOV2020 1 83
C4591001 1066 10661166 1/Prevax 02SEP2020 1 10
2/1 Month 21OCT2020 29 615
C4591001 1068 10681098 1/Prevax 03SEP2020 1 10
2/1 Month 22OCT2020 29 318
C4591001 1068 10681119 1/Prevax 10SEP2020 1 10
C4591001 1071 10711233 1/Prevax 19OCT2020 1 10
2/1 Month 10DEC2020 30 164
C4591001 1077 10771262 1/Prevax 20OCT2020 1 10
2/1 Month 07DEC2020 29 258
C4591001 1077 10771273 1/Prevax 02DEC2020 1 10
2/1 Month 25JAN2021 35 505
C4591001 1079 10791288 1/Prevax 16SEP2020 1 10
2/1 Month 04NOV2020 29 1001
C4591001 1082 10821014 1/Prevax 03AUG2020 1 10
090177e196ac9128\Final\Final On: 31-Mar-2021 13:00 (GMT)
Page 23
FDA-CBER-2022-5812-0223832
16.2.6.1 Listing of Assay Data – Subjects 12 Through 25 Years o f Age
Age Group (Years) Vaccine Group
(as Randomized) Subject Dose/
Sampling
Time Point Date of
Sample Rel
DayaNT50
(Titer)
2/1 Month 22SEP2020 29 240
C4591001 1082 10821036 2/1 Month 21SEP2020 28 1333
C4591001 1082 10821196 2/1 Month 30NOV2020 34 903
C4591001 1082 10821201 1/Prevax 19OCT2020 1 10
2/1 Month 08DEC2020 30 738
C4591001 1084 10841423 1/Prevax 18SEP2020 1 66
C4591001 1085 10851050 1/Prevax 06AUG2020 1 10
2/1 Month 30SEP2020 29 675
C4591001 1087 10871214 1/Prevax 26AUG2020 1 10
2/1 Month 15OCT2020 29 241
C4591001 1087 10871267 1/Prevax 31AUG2020 1 10
2/1 Month 19OCT2020 29 217
C4591001 1087 10871529 1/Prevax 29SEP2020 1 10
2/1 Month 17NOV2020 29 128
C4591001 1087 10871565 1/Prevax 15OCT2020 1 10
C4591001 1088 10881200 1/Prevax 11SEP2020 1 10
C4591001 1089 10891273 1/Prevax 09SEP2020 1 10
2/1 Month 30OCT2020 29 1424
C4591001 1089 10891306 2/1 Month 03NOV2020 30 605
C4591001 1090 10901031 1/Prevax 03AUG2020 1 10
2/1 Month 23SEP2020 31 780
C4591001 1090 10901043 1/Prevax 04AUG2020 1 10
2/1 Month 23SEP2020 31 2024
C4591001 1090 10901157 1/Prevax 12AUG2020 1 10
2/1 Month 02OCT2020 33 594
C4591001 1090 10901328 1/Prevax 03SEP2020 1 10
C4591001 1090 10901443 1/Prevax 22SEP2020 1 10
090177e196ac9128\Final\Final On: 31-Mar-2021 13:00 (GMT)
Page 24
FDA-CBER-2022-5812-0223833
16.2.6.1 Listing of Assay Data – Subjects 12 Through 25 Years o f Age
Age Group (Years) Vaccine Group
(as Randomized) Subject Dose/
Sampling
Time Point Date of
Sample Rel
DayaNT50
(Titer)
2/1 Month 13NOV2020 30 271
C4591001 1090 10901517 1/Prevax 20OCT2020 1 10
2/1 Month 09DEC2020 29 1154
C4591001 1090 10901559 2/1 Month 22DEC2020 36 529
C4591001 1091 10911382 1/Prevax 28OCT2020 1 10
2/1 Month 16DEC2020 29 2243
C4591001 1091 10911389 1/Prevax 18NOV2020 1 10
C4591001 1091 10911391 1/Prevax 25NOV2020 1 10
C4591001 1091 10911401 1/Prevax 04DEC2020 1 10
2/1 Month 27JAN2021 30 1504
C4591001 1092 10921146 1/Prevax 02SEP2020 1 10
2/1 Month 14JAN2021 113 214
C4591001 1093 10931088 1/Prevax 31AUG2020 1 18
2/1 Month 19OCT2020 29 1181
C4591001 1093 10931174 1/Prevax 12OCT2020 1 100
C4591001 1094 10941069 1/Prevax 28AUG2020 1 10
2/1 Month 19OCT2020 33 649
C4591001 1095 10951170 1/Prevax 29AUG2020 1 10
2/1 Month 16OCT2020 30 10629
C4591001 1095 10951271 1/Prevax 08OCT2020 1 10
C4591001 1095 10951315 2/1 Month 12JAN2021 29 1285
C4591001 1096 10961010 1/Prevax 13AUG2020 1 10
2/1 Month 29SEP2020 29 169
C4591001 1096 10961032 1/Prevax 14AUG2020 1 10
C4591001 1096 10961168 1/Prevax 28AUG2020 1 10
2/1 Month 21OCT2020 35 633
C4591001 1096 10961196 1/Prevax 31AUG2020 1 162
090177e196ac9128\Final\Final On: 31-Mar-2021 13:00 (GMT)
Page 25
FDA-CBER-2022-5812-0223834
16.2.6.1 Listing of Assay Data – Subjects 12 Through 25 Years o f Age
Age Group (Years) Vaccine Group
(as Randomized) Subject Dose/
Sampling
Time Point Date of
Sample Rel
DayaNT50
(Titer)
C4591001 1096 10961219 2/1 Month 20OCT2020 30 441
C4591001 1096 10961319 1/Prevax 12SEP2020 1 10
2/1 Month 02NOV2020 33 424
C4591001 1096 10961392 1/Prevax 23NOV2020 1 10
C4591001 1098 10981177 1/Prevax 16SEP2020 1 10
C4591001 1101 11011033 1/Prevax 10SEP2020 1 71
2/1 Month 29OCT2020 29 1018
C4591001 1101 11011062 2/1 Month 04NOV2020 29 1345
C4591001 1101 11011079 1/Prevax 18SEP2020 1 10
2/1 Month 06NOV2020 29 1885
C4591001 1101 11011088 1/Prevax 22SEP2020 1 39
2/1 Month 12NOV2020 31 1851
C4591001 1109 11091020 1/Prevax 30JUL2020 1 10
2/1 Month 15SEP2020 29 386
C4591001 1109 11091370 1/Prevax 29AUG2020 1 10
2/1 Month 15OCT2020 29 796
C4591001 1109 11091391 1/Prevax 01SEP2020 1 10
C4591001 1111 11111001 1/Prevax 30JUL2020 1 10
2/1 Month 17SEP2020 29 2220
C4591001 1111 11111183 1/Prevax 21SEP2020 1 10
C4591001 1112 11121019 2/1 Month 24SEP2020 34 323
C4591001 1112 11121217 1/Prevax 03SEP2020 1 10
2/1 Month 26OCT2020 34 280
C4591001 1112 11121297 1/Prevax 12OCT2020 1 10
2/1 Month 30NOV2020 29 399
C4591001 1114 11141021 1/Prevax 13AUG2020 1 10
C4591001 1116 11161256 1/Prevax 19SEP2020 1 10
090177e196ac9128\Final\Final On: 31-Mar-2021 13:00 (GMT)
Page 26
FDA-CBER-2022-5812-0223835
16.2.6.1 Listing of Assay Data – Subjects 12 Through 25 Years o f Age
Age Group (Years) Vaccine Group
(as Randomized) Subject Dose/
Sampling
Time Point Date of
Sample Rel
DayaNT50
(Titer)
2/1 Month 12NOV2020 32 879
C4591001 1116 11161320 1/Prevax 25SEP2020 1 10
C4591001 1117 11171113 2/1 Month 04NOV2020 30 671
C4591001 1118 11181017 2/1 Month 05OCT2020 33 745
C4591001 1118 11181101 2/1 Month 15OCT2020 29 879
C4591001 1120 11201337 1/Prevax 16OCT2020 1 10
2/1 Month 04JAN2021 60 1180
C4591001 1123 11231116 1/Prevax 17AUG2020 1 10
2/1 Month 07OCT2020 30 1295
C4591001 1123 11231381 1/Prevax 15OCT2020 1 10
2/1 Month 09DEC2020 34 2476
C4591001 1123 11231383 1/Prevax 15OCT2020 1 10
2/1 Month 07DEC2020 33 596
C4591001 1123 11231413 2/1 Month 13JAN2021 36 1210
C4591001 1123 11231417 1/Prevax 23NOV2020 1 10
C4591001 1123 11231423 2/1 Month 18JAN2021 29 475
C4591001 1123 11231429 1/Prevax 03DEC2020 1 10
C4591001 1124 11241071 1/Prevax 19AUG2020 1 10
2/1 Month 14OCT2020 35 770
C4591001 1125 11251144 1/Prevax 02SEP2020 1 10
2/1 Month 27OCT2020 29 5632
C4591001 1125 11251240 1/Prevax 20NOV2020 1 10
C4591001 1126 11261216 2/1 Month 13JAN2021 30 607
C4591001 1126 11261231 1/Prevax 30NOV2020 1 10
C4591001 1126 11261242 1/Prevax 02DEC2020 1 14
2/1 Month 22JAN2021 33 2069
C4591001 1127 11271021 2/1 Month 15SEP2020 29 725
090177e196ac9128\Final\Final On: 31-Mar-2021 13:00 (GMT)
Page 27
FDA-CBER-2022-5812-0223836
16.2.6.1 Listing of Assay Data – Subjects 12 Through 25 Years o f Age
Age Group (Years) Vaccine Group
(as Randomized) Subject Dose/
Sampling
Time Point Date of
Sample Rel
DayaNT50
(Titer)
C4591001 1127 11271033 2/1 Month 18SEP2020 31 251
C4591001 1129 11291262 1/Prevax 23NOV2020 1 10
2/1 Month 11JAN2021 29 693
C4591001 1130 11301089 1/Prevax 21OCT2020 1 10
2/1 Month 09DEC2020 29 130
C4591001 1131 11311064 1/Prevax 21AUG2020 1 10
C4591001 1131 11311266 1/Prevax 18NOV2020 1 17
2/1 Month 11JAN2021 35 1186
C4591001 1131 11311268 1/Prevax 23NOV2020 1 10
C4591001 1133 11331485 1/Prevax 21SEP2020 1 10
C4591001 1133 11331602 2/1 Month 17DEC2020 29 10
C4591001 1134 11341327 2/1 Month 06NOV2020 36 280
C4591001 1135 11351088 1/Prevax 08AUG2020 1 10
2/1 Month 25SEP2020 29 1168
C4591001 1135 11351113 1/Prevax 13AUG2020 1 10
2/1 Month 09OCT2020 32 1428
C4591001 1135 11351216 1/Prevax 26AUG2020 1 10
2/1 Month 16OCT2020 29 1244
C4591001 1135 11351355 1/Prevax 15SEP2020 1 311
2/1 Month 04NOV2020 30 805
C4591001 1135 11351410 2/1 Month 09NOV2020 29 1697
C4591001 1136 11361007 1/Prevax 18AUG2020 1 10
2/1 Month 12OCT2020 32 776
C4591001 1139 11391141 1/Prevax 24NOV2020 1 10
2/1 Month 14JAN2021 31 2154
C4591001 1140 11401006 1/Prevax 30JUL2020 1 10
2/1 Month 16SEP2020 29 627
090177e196ac9128\Final\Final On: 31-Mar-2021 13:00 (GMT)
Page 28
FDA-CBER-2022-5812-0223837
16.2.6.1 Listing of Assay Data – Subjects 12 Through 25 Years o f Age
Age Group (Years) Vaccine Group
(as Randomized) Subject Dose/
Sampling
Time Point Date of
Sample Rel
DayaNT50
(Titer)
C4591001 1141 11411006 1/Prevax 31JUL2020 1 35
C4591001 1141 11411072 1/Prevax 13AUG2020 1 10
2/1 Month 02OCT2020 31 362
C4591001 1141 11411081 1/Prevax 14AUG2020 1 10
2/1 Month 07OCT2020 36 395
C4591001 1141 11411141 1/Prevax 27AUG2020 1 10
2/1 Month 15OCT2020 29 633
C4591001 1141 11411187 2/1 Month 29OCT2020 29 1723
C4591001 1141 11411227 2/1 Month 10NOV2020 33 1738
C4591001 1141 11411236 2/1 Month 13NOV2020 36 363
C4591001 1141 11411263 1/Prevax 19OCT2020 1 10
2/1 Month 07DEC2020 29 1138
C4591001 1141 11411269 1/Prevax 27OCT2020 1 10
C4591001 1142 11421037 1/Prevax 04AUG2020 1 10
2/1 Month 29SEP2020 33 794
C4591001 1142 11421100 1/Prevax 14AUG2020 1 10
2/1 Month 02OCT2020 30 1055
C4591001 1142 11421274 1/Prevax 07OCT2020 1 10
2/1 Month 02DEC2020 36 678
C4591001 1142 11421338 1/Prevax 04DEC2020 1 10
C4591001 1146 11461292 2/1 Month 14DEC2020 33 487
C4591001 1146 11461316 2/1 Month 11DEC2020 31 1103
C4591001 1146 11461378 2/1 Month 15DEC2020 29 490
C4591001 1147 11471255 1/Prevax 14NOV2020 1 10
2/1 Month 11JAN2021 38 1087
C4591001 1149 11491050 1/Prevax 11AUG2020 1 10
2/1 Month 30SEP2020 30 270
090177e196ac9128\Final\Final On: 31-Mar-2021 13:00 (GMT)
Page 29
FDA-CBER-2022-5812-0223838
16.2.6.1 Listing of Assay Data – Subjects 12 Through 25 Years o f Age
Age Group (Years) Vaccine Group
(as Randomized) Subject Dose/
Sampling
Time Point Date of
Sample Rel
DayaNT50
(Titer)
C4591001 1149 11491079 1/Prevax 17AUG2020 1 10
C4591001 1149 11491218 1/Prevax 08SEP2020 1 10
2/1 Month 27OCT2020 29 793
C4591001 1149 11491255 1/Prevax 18SEP2020 1 10
2/1 Month 11NOV2020 34 299
C4591001 1149 11491302 1/Prevax 24SEP2020 1 10
C4591001 1150 11501016 1/Prevax 19AUG2020 1 10
C4591001 1150 11501181 2/1 Month 01FEB2021 36 343
C4591001 1152 11521011 2/1 Month 30SEP2020 30 551
C4591001 1152 11521019 1/Prevax 12AUG2020 1 10
2/1 Month 30SEP2020 29 1086
C4591001 1152 11521114 1/Prevax 19AUG2020 1 10
2/1 Month 09OCT2020 30 1078
C4591001 1152 11521115 1/Prevax 19AUG2020 1 10
C4591001 1152 11521149 2/1 Month 09OCT2020 29 653
C4591001 1152 11521164 1/Prevax 24AUG2020 1 10
2/1 Month 12OCT2020 29 481
C4591001 1152 11521357 2/1 Month 21OCT2020 29 700
C4591001 1152 11521451 1/Prevax 16SEP2020 1 10
C4591001 1152 11521464 1/Prevax 18SEP2020 1 10
C4591001 1152 11521505 1/Prevax 09OCT2020 1 10
2/1 Month 04DEC2020 36 536
C4591001 1152 11521534 1/Prevax 16OCT2020 1 10
2/1 Month 02DEC2020 29 313
C4591001 1152 11521587 1/Prevax 16NOV2020 1 10
2/1 Month 04JAN2021 29 1075
C4591001 1152 11521588 1/Prevax 16NOV2020 1 10
090177e196ac9128\Final\Final On: 31-Mar-2021 13:00 (GMT)
Page 30
FDA-CBER-2022-5812-0223839
16.2.6.1 Listing of Assay Data – Subjects 12 Through 25 Years o f Age
Age Group (Years) Vaccine Group
(as Randomized) Subject Dose/
Sampling
Time Point Date of
Sample Rel
DayaNT50
(Titer)
2/1 Month 04JAN2021 29 177
C4591001 1152 11521589 1/Prevax 17NOV2020 1 10
2/1 Month 06JAN2021 31 1948
C4591001 1152 11521600 1/Prevax 24NOV2020 1 10
2/1 Month 12JAN2021 29 1272
C4591001 1152 11521601 1/Prevax 24NOV2020 1 10
2/1 Month 19JAN2021 36 2877
C4591001 1152 11521634 2/1 Month 25JAN2021 29 455
C4591001 1156 11561155 2/1 Month 13NOV2020 36 1224
C4591001 1156 11561229 1/Prevax 12OCT2020 1 10
2/1 Month 03DEC2020 30 7789
C4591001 1156 11561258 1/Prevax 20OCT2020 1 17
2/1 Month 14DEC2020 34 797
C4591001 1156 11561288 1/Prevax 30OCT2020 1 10
C4591001 1156 11561291 1/Prevax 30OCT2020 1 10
2/1 Month 17DEC2020 29 241
C4591001 1162 11621051 2/1 Month 25SEP2020 29 1609
C4591001 1162 11621110 1/Prevax 13AUG2020 1 10
2/1 Month 06OCT2020 35 308
C4591001 1162 11621418 2/1 Month 12NOV2020 32 795
C4591001 1163 11631048 1/Prevax 06AUG2020 1 10
2/1 Month 22SEP2020 29 1942
C4591001 1163 11631106 2/1 Month 29SEP2020 29 268
C4591001 1166 11661008 1/Prevax 18AUG2020 1 10
2/1 Month 06OCT2020 29 168
C4591001 1166 11661048 1/Prevax 31AUG2020 1 10
2/1 Month 21OCT2020 31 970
090177e196ac9128\Final\Final On: 31-Mar-2021 13:00 (GMT)
Page 31
FDA-CBER-2022-5812-0223840
16.2.6.1 Listing of Assay Data – Subjects 12 Through 25 Years o f Age
Age Group (Years) Vaccine Group
(as Randomized) Subject Dose/
Sampling
Time Point Date of
Sample Rel
DayaNT50
(Titer)
C4591001 1167 11671142 1/Prevax 04SEP2020 1 10
2/1 Month 21OCT2020 29 95
C4591001 1167 11671224 1/Prevax 24SEP2020 1 10
2/1 Month 12NOV2020 31 337
C4591001 1168 11681035 1/Prevax 17AUG2020 1 10
2/1 Month 06OCT2020 29 755
C4591001 1168 11681069 1/Prevax 21AUG2020 1 10
C4591001 1168 11681098 2/1 Month 15OCT2020 29 919
C4591001 1168 11681135 1/Prevax 03SEP2020 1 10
2/1 Month 30OCT2020 29 935
C4591001 1168 11681219 2/1 Month 02DEC2020 35 4878
C4591001 1168 11681224 1/Prevax 08OCT2020 1 10
2/1 Month 01DEC2020 35 555
C4591001 1171 11711027 1/Prevax 14AUG2020 1 10
2/1 Month 02OCT2020 29 1685
C4591001 1171 11711211 1/Prevax 09SEP2020 1 10
C4591001 1171 11711240 1/Prevax 11SEP2020 1 10
2/1 Month 06NOV2020 37 939
C4591001 1177 11771393 2/1 Month 06NOV2020 29 866
C4591001 1177 11771428 2/1 Month 12NOV2020 29 1045
C4591001 1177 11771540 1/Prevax 20OCT2020 1 10
C4591001 1177 11771550 2/1 Month 09DEC2020 29 920
C4591001 1178 11781098 2/1 Month 23OCT2020 29 318
C4591001 1178 11781156 1/Prevax 11SEP2020 1 10
2/1 Month 29OCT2020 29 499
C4591001 1178 11781161 1/Prevax 11SEP2020 1 10
2/1 Month 02NOV2020 33 536
090177e196ac9128\Final\Final On: 31-Mar-2021 13:00 (GMT)
Page 32
FDA-CBER-2022-5812-0223841
16.2.6.1 Listing of Assay Data – Subjects 12 Through 25 Years o f Age
Age Group (Years) Vaccine Group
(as Randomized) Subject Dose/
Sampling
Time Point Date of
Sample Rel
DayaNT50
(Titer)
C4591001 1178 11781187 1/Prevax 16SEP2020 1 10
2/1 Month 09NOV2020 34 905
C4591001 1178 11781301 1/Prevax 14OCT2020 1 10
2/1 Month 02DEC2020 30 144
C4591001 1204 12041088 1/Prevax 10SEP2020 1 10
2/1 Month 13NOV2020 43 596
C4591001 1204 12041275 1/Prevax 21OCT2020 1 10
C4591001 1221 12211036 1/Prevax 16NOV2020 1 10
C4591001 1223 12231117 1/Prevax 05SEP2020 1 10
2/1 Month 27OCT2020 30 745
C4591001 1224 12241136 1/Prevax 04SEP2020 1 10
2/1 Month 30OCT2020 37 1027
C4591001 1224 12241187 1/Prevax 04DEC2020 1 10
C4591001 1232 12321028 1/Prevax 17AUG2020 1 10
2/1 Month 06OCT2020 29 393
C4591001 1232 12321302 1/Prevax 06OCT2020 1 10
C4591001 1235 12351003 2/1 Month 20OCT2020 29 574
C4591001 1235 12351014 1/Prevax 04SEP2020 1 10
C4591001 1235 12351053 2/1 Month 27OCT2020 29 2872
C4591001 1235 12351230 1/Prevax 03NOV2020 1 10
C4591001 1241 12411885 1/Prevax 18SEP2020 1 10
2/1 Month 13NOV2020 36 570
C4591001 1248 12481033 1/Prevax 29AUG2020 1 10
2/1 Month 21OCT2020 32 360
C4591001 1248 12481038 1/Prevax 30AUG2020 1 10
2/1 Month 19OCT2020 30 694
C4591001 1254 12541193 2/1 Month 05DEC2020 29 636
090177e196ac9128\Final\Final On: 31-Mar-2021 13:00 (GMT)
Page 33
FDA-CBER-2022-5812-0223842
16.2.6.1 Listing of Assay Data – Subjects 12 Through 25 Years o f Age
Age Group (Years) Vaccine Group
(as Randomized) Subject Dose/
Sampling
Time Point Date of
Sample Rel
DayaNT50
(Titer)
C4591001 1258 12581023 1/Prevax 09SEP2020 1 10
2/1 Month 02NOV2020 29 2021
C4591001 1258 12581065 2/1 Month 07DEC2020 29 1777
C4591001 1264 12641095 1/Prevax 02SEP2020 1 10
C4591001 1270 12701153 1/Prevax 12NOV2020 1 10
2/1 Month 06JAN2021 36 569
C4591001 1270 12701156 1/Prevax 18NOV2020 1 10
2/1 Month 07JAN2021 30 1528
C4591001 1270 12701169 2/1 Month 18JAN2021 34 618
Placebo C4591001 1003 10031111 1/Prevax 30JUL2020 1 10
2/1 Month 23SEP2020 35 10
C4591001 1006 10061136 1/Prevax 01SEP2020 1 10
2/1 Month 20OCT2020 29 10
C4591001 1006 10061159 1/Prevax 24SEP2020 1 10
C4591001 1006 10061194 1/Prevax 02DEC2020 1 10
2/1 Month 20JAN2021 29 10
C4591001 1007 10071082 1/Prevax 28JUL2020 1 10
2/1 Month 16SEP2020 29 10
C4591001 1009 10091235 1/Prevax 21OCT2020 1 10
C4591001 1013 10131005 1/Prevax 28JUL2020 1 10
2/1 Month 16SEP2020 29 10
C4591001 1013 10131020 1/Prevax 30JUL2020 1 10
2/1 Month 21SEP2020 34 10
C4591001 1013 10131060 1/Prevax 03AUG2020 1 10
2/1 Month 21SEP2020 29 10
C4591001 1016 10161003 1/Prevax 29JUL2020 1 10
2/1 Month 16SEP2020 29 10
090177e196ac9128\Final\Final On: 31-Mar-2021 13:00 (GMT)
Page 34
FDA-CBER-2022-5812-0223843
16.2.6.1 Listing of Assay Data – Subjects 12 Through 25 Years o f Age
Age Group (Years) Vaccine Group
(as Randomized) Subject Dose/
Sampling
Time Point Date of
Sample Rel
DayaNT50
(Titer)
C4591001 1016 10161014 1/Prevax 30JUL2020 1 10
2/1 Month 16SEP2020 29 10
C4591001 1016 10161299 1/Prevax 23SEP2020 1 10
2/1 Month 12NOV2020 29 10
C4591001 1028 10281094 1/Prevax 01SEP2020 1 10
2/1 Month 22OCT2020 29 10
C4591001 1028 10281184 2/1 Month 03NOV2020 29 10
C4591001 1028 10281211 1/Prevax 21SEP2020 1 10
2/1 Month 18NOV2020 35 10
C4591001 1028 10281248 1/Prevax 07OCT2020 1 10
2/1 Month 23NOV2020 29 10
C4591001 1042 10421003 1/Prevax 29JUL2020 1 10
2/1 Month 17SEP2020 32 10
C4591001 1042 10421111 1/Prevax 17AUG2020 1 10
2/1 Month 07OCT2020 29 10
C4591001 1042 10421112 1/Prevax 17AUG2020 1 10
2/1 Month 09OCT2020 31 10
C4591001 1066 10661290 1/Prevax 22SEP2020 1 10
2/1 Month 09NOV2020 29 10
C4591001 1079 10791013 1/Prevax 30JUL2020 1 10
2/1 Month 23SEP2020 36 10
C4591001 1079 10791162 1/Prevax 20AUG2020 1 10
C4591001 1080 10801055 1/Prevax 18AUG2020 1 10
2/1 Month 07OCT2020 30 10
C4591001 1083 10831001 1/Prevax 29JUL2020 1 10
2/1 Month 18SEP2020 29 10
C4591001 1085 10851003 1/Prevax 30JUL2020 1 10
090177e196ac9128\Final\Final On: 31-Mar-2021 13:00 (GMT)
Page 35
FDA-CBER-2022-5812-0223844
16.2.6.1 Listing of Assay Data – Subjects 12 Through 25 Years o f Age
Age Group (Years) Vaccine Group
(as Randomized) Subject Dose/
Sampling
Time Point Date of
Sample Rel
DayaNT50
(Titer)
C4591001 1087 10871061 2/1 Month 29SEP2020 29 10
C4591001 1089 10891015 1/Prevax 30JUL2020 1 10
2/1 Month 21SEP2020 35 10
C4591001 1092 10921083 1/Prevax 26AUG2020 1 10
2/1 Month 15OCT2020 30 10
C4591001 1093 10931203 1/Prevax 23OCT2020 1 10
C4591001 1094 10941076 1/Prevax 01SEP2020 1 10
2/1 Month 22OCT2020 29 10
C4591001 1095 10951002 1/Prevax 30JUL2020 1 10
2/1 Month 18SEP2020 29 10
C4591001 1095 10951106 1/Prevax 07AUG2020 1 10
2/1 Month 28SEP2020 32 10
C4591001 1095 10951312 1/Prevax 20NOV2020 1 10
2/1 Month 11JAN2021 32 10
C4591001 1107 11071010 1/Prevax 30JUL2020 1 38
2/1 Month 21SEP2020 35 67
C4591001 1109 11091030 1/Prevax 30JUL2020 1 10
C4591001 1109 11091092 1/Prevax 01AUG2020 1 10
2/1 Month 26SEP2020 35 10
C4591001 1109 11091309 1/Prevax 22AUG2020 1 10
2/1 Month 19OCT2020 40 10
C4591001 1112 11121125 1/Prevax 17AUG2020 1 10
2/1 Month 12OCT2020 34 16
C4591001 1112 11121260 1/Prevax 06OCT2020 1 10
C4591001 1116 11161322 1/Prevax 25SEP2020 1 10
C4591001 1118 11181059 1/Prevax 19AUG2020 1 10
2/1 Month 09OCT2020 29 10
090177e196ac9128\Final\Final On: 31-Mar-2021 13:00 (GMT)
Page 36
FDA-CBER-2022-5812-0223845
16.2.6.1 Listing of Assay Data – Subjects 12 Through 25 Years o f Age
Age Group (Years) Vaccine Group
(as Randomized) Subject Dose/
Sampling
Time Point Date of
Sample Rel
DayaNT50
(Titer)
C4591001 1126 11261211 1/Prevax 17NOV2020 1 10
2/1 Month 06JAN2021 29 10
C4591001 1129 11291265 1/Prevax 03DEC2020 1 10
2/1 Month 21JAN2021 31 10
C4591001 1139 11391167 1/Prevax 11DEC2020 1 10
2/1 Month 01FEB2021 34 10
C4591001 1141 11411226 2/1 Month 10NOV2020 29 10
C4591001 1146 11461342 2/1 Month 14DEC2020 29 10
C4591001 1152 11521009 1/Prevax 12AUG2020 1 10
2/1 Month 30SEP2020 29 10
C4591001 1152 11521222 2/1 Month 14OCT2020 31 10
C4591001 1168 11681088 1/Prevax 26AUG2020 1 10
2/1 Month 20OCT2020 35 95
C4591001 1168 11681090 2/1 Month 15OCT2020 29 10
C4591001 1171 11711152 2/1 Month 20OCT2020 30 10
C4591001 1171 11711221 2/1 Month 26OCT2020 29 10
C4591001 1204 12041061 1/Prevax 08SEP2020 1 10
2/1 Month 26OCT2020 29 10
C4591001 1221 12211006 2/1 Month 04DEC2020 31 10
C4591001 1223 12231113 1/Prevax 05SEP2020 1 10
2/1 Month 27OCT2020 30 10
C4591001 1231 12311556 1/Prevax 16AUG2020 1 10
2/1 Month 09OCT2020 33 10
Abbreviation: NT50 = 50% neutralizing titer.
a. Relative day (Rel Day) = da te of blood draw - date of la st vaccination + 1.
PFIZER CONFIDENTIAL SDTM Creation: 25MAR2021 (23:25) Source Data: adva Table Generation: 27MAR2021 (16:43)
(Cutoff Date: 13MAR2021, Snapshot Date: 25MAR2021) Output File: ./nda2 _unblinded/C4591001 _BLA/adva _l001_ped
090177e196ac9128\Final\Final On: 31-Mar-2021 13:00 (GMT)
Page 37
FDA-CBER-2022-5812-0223846