Document text
16.2.6.1.1 Listing of Assay Data – Phase 1, 2 Doses, 21 Days Apar t
Assay
Vaccine
Candidate Age Group
(Years) Vaccine Group
(as Randomized) Subject Dose/
Sampling
Time Point Date of
Sample Rel
Daya NT50
(Titer) NT90
(Titer) S1-Binding
IgG Level
(U/mL) RBD -Binding
IgG Level
(U/mL)
BNT162b1 18-55 10 μg C4591001 1001 10011004 1/Prevax 04MAY2020 1 10.00 10.00 BLQ BLQ
1/Day 7 11MAY2020 8 10.00 10.00 BLQ BLQ
1/Day 21 26MAY2020 23 10.00 10.00 97.467 143.277
2/Day 7 02JUN2020 8 87.87 43.45 6043.129 8972.305
2/Day 14 09JUN2020 15 101.66 50.89 2919.643 3468.993
2/1 Month 29JUN2020 35 52.59 28.70 1490.371 2570.157
C4591001 1001 10011006 1/Prevax 06MAY2020 1 10.00 10.00 BLQ BLQ
1/Day 7 13MAY2020 8 10.00 10.00 BLQ BLQ
1/Day 21 27MAY2020 22 10.00 10.00 969.029 1326.542
2/Day 7 02JUN2020 7 222.45 71.47 3208.576 2485.842
2/Day 14 09JUN2020 14 303.90 131.81 3997.389 4604.990
2/1 Month 24JUN2020 29 127.36 41.28 2173.044 3628.212
C4591001 1001 10011007 1/Prevax 06MAY2020 1 10.00 10.00 BLQ BLQ
1/Day 7 14MAY2020 9 10.00 10.00 BLQ 1.448
1/Day 21 28MAY2020 23 10.88 10.00 799.812 1649.789
2/Day 7 03JUN2020 7 194.93 86.40 6380.014 9788.312
090177e194f60646\Final\Final On: 19-Sep-2020 01:53 (GMT)
Page 1
FDA-CBER-2021-5683-0019447
16.2.6.1.1 Listing of Assay Data – Phase 1, 2 Doses, 21 Days Apar t
Assay
Vaccine
Candidate Age Group
(Years) Vaccine Group
(as Randomized) Subject Dose/
Sampling
Time Point Date of
Sample Rel
Daya NT50
(Titer) NT90
(Titer) S1-Binding
IgG Level
(U/mL) RBD -Binding
IgG Level
(U/mL)
2/Day 14 09JUN2020 13 402.49 197.89 10288.068 11336.201
2/1 Month 25JUN2020 29 118.71 52.56 4448.945 4638.109
C4591001 1001 10011008 1/Prevax 06MAY2020 1 10.00 10.00 BLQ BLQ
1/Day 7 13MAY2020 8 10.11 10.00 BLQ BLQ
1/Day 21 27MAY2020 22 10.00 10.00 64.328 175.715
2/Day 7 03JUN2020 8 167.34 80.77 10305.319 17058.986
2/Day 14 08JUN2020 13 149.65 67.74 6169.077 6250.007
2/1 Month 25JUN2020 30 64.99 28.77 1911.373 2544.193
C4591001 1001 10011009 1/Prevax 06MAY2020 1 10.00 10.00 5.575 4.937
1/Day 7 13MAY2020 8 10.00 10.00 4.866 11.037
1/Day 21 27MAY2020 22 23.20 10.24 1979.967 3261.180
2/Day 7 02JUN2020 7 311.44 133.72 14441.924 18686.578
2/Day 14 09JUN2020 14 437.33 214.86 10924.495 12114.155
2/1 Month 30JUN2020 35 189.69 119.97 9557.915 5836.724
C4591001 1002 10021003 1/Prevax 04MAY2020 1 10.00 10.00 BLQ 1.377
1/Day 7 11MAY2020 8 10.00 10.00 BLQ BLQ
090177e194f60646\Final\Final On: 19-Sep-2020 01:53 (GMT)
Page 2
FDA-CBER-2021-5683-0019448
16.2.6.1.1 Listing of Assay Data – Phase 1, 2 Doses, 21 Days Apar t
Assay
Vaccine
Candidate Age Group
(Years) Vaccine Group
(as Randomized) Subject Dose/
Sampling
Time Point Date of
Sample Rel
Daya NT50
(Titer) NT90
(Titer) S1-Binding
IgG Level
(U/mL) RBD -Binding
IgG Level
(U/mL)
1/Day 21 26MAY2020 23 33.53 11.53 772.166 1064.379
2/Day 7 01JUN2020 7 574.20 183.83 6370.953 8136.629
2/Day 14 10JUN2020 16 438.27 168.43 9135.979 7964.196
2/1 Month 29JUN2020 35 129.35 74.87 4648.066 10347.947
C4591001 1002 10021004 1/Prevax 04MAY2020 1 10.00 10.00 BLQ BLQ
1/Day 7 11MAY2020 8 10.00 10.00 BLQ BLQ
1/Day 21 26MAY2020 23 10.00 10.00 157.823 318.829
2/Day 7 01JUN2020 7 154.56 44.40 2182.489 2693.702
2/Day 14 10JUN2020 16 183.75 74.28 4293.955 5822.329
2/1 Month 29JUN2020 35 49.58 26.61 2126.630 3012.480
C4591001 1002 10021007 1/Prevax 06MAY2020 1 10.00 10.00 BLQ 2.416
1/Day 7 12MAY2020 7 10.00 10.00 BLQ 2.088
1/Day 21 26MAY2020 21 22.47 10.00 404.919 663.500
2/Day 7 01JUN2020 7 146.46 45.63 2250.101 3054.764
2/Day 14 10JUN2020 16 79.89 38.95 3574.494 4144.287
2/1 Month 29JUN2020 35 53.31 23.93 1656.706 2611.830
090177e194f60646\Final\Final On: 19-Sep-2020 01:53 (GMT)
Page 3
FDA-CBER-2021-5683-0019449
16.2.6.1.1 Listing of Assay Data – Phase 1, 2 Doses, 21 Days Apar t
Assay
Vaccine
Candidate Age Group
(Years) Vaccine Group
(as Randomized) Subject Dose/
Sampling
Time Point Date of
Sample Rel
Daya NT50
(Titer) NT90
(Titer) S1-Binding
IgG Level
(U/mL) RBD -Binding
IgG Level
(U/mL)
C4591001 1002 10021009 1/Prevax 06MAY2020 1 10.00 10.00 BLQ BLQ
1/Day 7 12MAY2020 7 11.24 10.00 BLQ BLQ
1/Day 21 26MAY2020 21 10.00 10.00 181.439 227.059
2/Day 7 01JUN2020 7 201.54 69.01 5151.052 5722.187
2/Day 14 10JUN2020 16 244.95 92.12 5382.814 5798.988
2/1 Month 02JUL2020 38 84.17 36.75 3061.763 3563.048
C4591001 1002 10021011 1/Prevax 06MAY2020 1 10.00 10.00 BLQ BLQ
1/Day 7 12MAY2020 7 10.03 10.00 BLQ BLQ
1/Day 21 26MAY2020 21 10.00 10.00 20.884 51.158
2/Day 7 01JUN2020 7 38.79 10.00 292.938 419.289
2/Day 14 10JUN2020 16 37.18 10.00 2455.135 3256.220
2/1 Month 29JUN2020 35 10.00 10.00 1114.547 2233.902
C4591001 1002 10021012 1/Prevax 05MAY2020 1 10.00 10.00 BLQ BLQ
1/Day 7 12MAY2020 8 10.10 10.00 BLQ BLQ
1/Day 21 26MAY2020 22 14.68 10.00 829.023 1661.676
2/Day 7 01JUN2020 7 160.07 53.17 4683.845 5405.907
090177e194f60646\Final\Final On: 19-Sep-2020 01:53 (GMT)
Page 4
FDA-CBER-2021-5683-0019450
16.2.6.1.1 Listing of Assay Data – Phase 1, 2 Doses, 21 Days Apar t
Assay
Vaccine
Candidate Age Group
(Years) Vaccine Group
(as Randomized) Subject Dose/
Sampling
Time Point Date of
Sample Rel
Daya NT50
(Titer) NT90
(Titer) S1-Binding
IgG Level
(U/mL) RBD -Binding
IgG Level
(U/mL)
2/Day 14 10JUN2020 16 337.24 100.54 10239.561 11950.095
2/1 Month 29JUN2020 35 99.04 61.45 3937.063 8490.545
C4591001 1002 10021013 1/Prevax 06MAY2020 1 10.00 10.00 BLQ BLQ
1/Day 7 12MAY2020 7 10.00 10.00 BLQ BLQ
1/Day 21 26MAY2020 21 10.00 10.00 282.032 693.957
2/Day 7 01JUN2020 7 154.85 28.19 2756.690 2557.636
2/Day 14 10JUN2020 16 72.39 45.79 2114.625 2875.554
2/1 Month 29JUN2020 35 37.91 28.10 1191.868 1712.777
20 μg C4591001 1001 10011067 1/Prevax 01JUL2020 1 10.00 10.00 BLQ BLQ
1/Day 21 22JUL2020 22 10.00 10.00 378.972 847.958
2/Day 7 30JUL2020 9 315.34 39.65 7913.944 11707.132
2/Day 14 06AUG2020 16 203.20 68.53 10197.655 10048.742
2/1 Month 20AUG2020 30 235.29 52.94 6066.307 8316.934
C4591001 1001 10011068 1/Prevax 29JUN2020 1 10.00 10.00 BLQ BLQ
1/Day 21 20JUL2020 22 34.34 10.00 628.447 1138.758
2/Day 7 27JUL2020 8 591.71 155.61 13025.472 13172.847
090177e194f60646\Final\Final On: 19-Sep-2020 01:53 (GMT)
Page 5
FDA-CBER-2021-5683-0019451
16.2.6.1.1 Listing of Assay Data – Phase 1, 2 Doses, 21 Days Apar t
Assay
Vaccine
Candidate Age Group
(Years) Vaccine Group
(as Randomized) Subject Dose/
Sampling
Time Point Date of
Sample Rel
Daya NT50
(Titer) NT90
(Titer) S1-Binding
IgG Level
(U/mL) RBD -Binding
IgG Level
(U/mL)
2/Day 14 03AUG2020 15 603.52 204.04 13998.458 10727.289
2/1 Month 20AUG2020 32 269.36 76.69 9953.624 11703.404
C4591001 1001 10011070 1/Prevax 01JUL2020 1 10.00 10.00 BLQ 4.988
1/Day 21 22JUL2020 22 10.00 10.00 405.217 677.127
2/Day 7 29JUL2020 8 115.89 74.29 5181.079 7008.581
2/Day 14 05AUG2020 15 120.39 69.90 5184.289 5600.483
2/1 Month 21AUG2020 31 92.14 23.91 3437.577 3724.189
C4591001 1001 10011071 1/Prevax 01JUL2020 1 10.00 10.00 BLQ BLQ
1/Day 21 22JUL2020 22 10.00 10.00 BLQ BLQ
2/Day 7 29JUL2020 8 10.00 10.00 1.664 1.791
2/Day 14 05AUG2020 15 154.67 85.46 2836.680 1809.879
2/1 Month 21AUG2020 31 168.36 53.44 4224.593 6929.551
C4591001 1001 10011076 1/Prevax 01JUL2020 1 10.00 10.00 1.474 7.279
1/Day 21 21JUL2020 21 10.00 10.00 898.314 2780.058
2/Day 7 27JUL2020 7 186.26 80.77 2538.854 4638.101
2/Day 14 05AUG2020 16 526.89 272.16 12181.136 14033.873
090177e194f60646\Final\Final On: 19-Sep-2020 01:53 (GMT)
Page 6
FDA-CBER-2021-5683-0019452
16.2.6.1.1 Listing of Assay Data – Phase 1, 2 Doses, 21 Days Apar t
Assay
Vaccine
Candidate Age Group
(Years) Vaccine Group
(as Randomized) Subject Dose/
Sampling
Time Point Date of
Sample Rel
Daya NT50
(Titer) NT90
(Titer) S1-Binding
IgG Level
(U/mL) RBD -Binding
IgG Level
(U/mL)
2/1 Month 19AUG2020 30 520.68 132.06 6666.849 12219.509
C4591001 1002 10021079 1/Prevax 29JUN2020 1 10.00 10.00 BLQ BLQ
1/Day 21 21JUL2020 23 43.35 10.00 759.504 1563.955
2/Day 7 28JUL2020 8 247.31 141.96 9520.895 14769.983
2/Day 14 04AUG2020 15 522.18 231.79 19431.792 9467.770
2/1 Month 18AUG2020 29 390.73
9747.246 10494.930
C4591001 1002 10021080 1/Prevax 01JUL2020 1 10.00 10.00 BLQ BLQ
1/Day 21 21JUL2020 21 10.00 10.00 145.640 323.970
2/Day 7 29JUL2020 9 90.76 56.13 3718.181 5543.657
2/Day 14 04AUG2020 15 51.87 37.57 3596.124 3898.582
2/1 Month 18AUG2020 29 78.92 10.00 2384.033 2738.574
C4591001 1002 10021081 1/Prevax 01JUL2020 1 10.00 10.00 BLQ BLQ
1/Day 21 21JUL2020 21 10.00 10.00 968.969 1332.963
2/Day 7 29JUL2020 9 624.92
11447.375 15676.431
2/Day 14 06AUG2020 17 244.69 153.06 12389.591 9814.939
2/1 Month 18AUG2020 29 186.83 63.56 6268.530 5127.471
090177e194f60646\Final\Final On: 19-Sep-2020 01:53 (GMT)
Page 7
FDA-CBER-2021-5683-0019453
16.2.6.1.1 Listing of Assay Data – Phase 1, 2 Doses, 21 Days Apar t
Assay
Vaccine
Candidate Age Group
(Years) Vaccine Group
(as Randomized) Subject Dose/
Sampling
Time Point Date of
Sample Rel
Daya NT50
(Titer) NT90
(Titer) S1-Binding
IgG Level
(U/mL) RBD -Binding
IgG Level
(U/mL)
C4591001 1002 10021082 1/Prevax 01JUL2020 1 10.00 10.00 BLQ BLQ
1/Day 21 21JUL2020 21 10.00 10.00 211.055 399.276
2/Day 7 29JUL2020 9 119.10 54.23 5724.805 4613.399
2/Day 14 03AUG2020 14 111.38 55.37 6643.137 4426.357
2/1 Month 24AUG2020 35 70.10 24.64 4136.832 3901.389
C4591001 1002 10021084 1/Prevax 29JUN2020 1 10.00 10.00 BLQ BLQ
1/Day 21 21JUL2020 23 10.00 10.00 59.385 122.114
2/Day 7 28JUL2020 8 83.67 75.53 6098.693 4425.127
2/Day 14 04AUG2020 15 165.33 145.19 10107.783 5007.240
2/1 Month 18AUG2020 29 96.51 32.97 3450.292 3802.489
C4591001 1002 10021085 1/Prevax 29JUN2020 1 10.00 10.00 BLQ 8.223
1/Day 21 21JUL2020 23 10.00 10.00 329.432 509.752
2/Day 7 28JUL2020 8 249.12 79.98 10270.154 14400.364
2/Day 14 04AUG2020 15 377.07 242.46 12163.676 10843.163
2/1 Month 18AUG2020 29 258.30 48.41 13729.658 14015.486
C4591001 1002 10021087 1/Prevax 01JUL2020 1 10.00 10.00 2.148 3.613
090177e194f60646\Final\Final On: 19-Sep-2020 01:53 (GMT)
Page 8
FDA-CBER-2021-5683-0019454
16.2.6.1.1 Listing of Assay Data – Phase 1, 2 Doses, 21 Days Apar t
Assay
Vaccine
Candidate Age Group
(Years) Vaccine Group
(as Randomized) Subject Dose/
Sampling
Time Point Date of
Sample Rel
Daya NT50
(Titer) NT90
(Titer) S1-Binding
IgG Level
(U/mL) RBD -Binding
IgG Level
(U/mL)
1/Day 21 21JUL2020 21 10.00 10.00 214.476 293.395
2/Day 7 28JUL2020 8 205.67 125.36 4128.338 5477.359
2/Day 14 05AUG2020 16 87.70 55.21 1697.801 3385.951
2/1 Month 24AUG2020 35 59.69 25.02 3144.363 3532.892
30 μg C4591001 1001 10011011 1/Prevax 11MAY2020 1 10.00 10.00 BLQ BLQ
1/Day 7 18MAY2020 8 10.00 10.00 BLQ BLQ
1/Day 21 01JUN2020 22 39.25 10.00 2345.245 3150.906
2/Day 7 08JUN2020 8 590.89 247.72 51208.598 57805.171
2/Day 14 15JUN2020 15 1084.34 567.10 28781.566 36148.053
2/1 Month 29JUN2020 29 446.29 119.16 17036.801 18797.897
C4591001 1001 10011012 1/Prevax 13MAY2020 1 10.00 10.00 2.274 BLQ
1/Day 7 19MAY2020 7 10.00 10.00 6.056 BLQ
1/Day 21 03JUN2020 22 20.90 10.00 459.360 670.030
2/Day 7 11JUN2020 9 283.89 119.83 21009.138 24308.960
2/Day 14 16JUN2020 14 369.84 158.03 13645.018 15626.934
2/1 Month 01JUL2020 29 154.55 34.30 6232.219 4872.370
090177e194f60646\Final\Final On: 19-Sep-2020 01:53 (GMT)
Page 9
FDA-CBER-2021-5683-0019455
16.2.6.1.1 Listing of Assay Data – Phase 1, 2 Doses, 21 Days Apar t
Assay
Vaccine
Candidate Age Group
(Years) Vaccine Group
(as Randomized) Subject Dose/
Sampling
Time Point Date of
Sample Rel
Daya NT50
(Titer) NT90
(Titer) S1-Binding
IgG Level
(U/mL) RBD -Binding
IgG Level
(U/mL)
C4591001 1001 10011015 1/Prevax 11MAY2020 1 10.00 10.00 BLQ BLQ
1/Day 7 18MAY2020 8 10.00 10.00 BLQ BLQ
1/Day 21 01JUN2020 22 150.85 38.21 2770.128 2897.508
2/Day 7 08JUN2020 8 588.44 253.48 32898.066 46247.915
2/Day 14 15JUN2020 15 547.04 163.76 12722.076 15937.240
2/1 Month 29JUN2020 29 326.51 109.15 14931.112 13660.808
C4591001 1001 10011017 1/Prevax 13MAY2020 1 10.00 10.00 2.128 10.532
1/Day 7 20MAY2020 8 10.00 10.00 3.200 9.938
1/Day 21 03JUN2020 22 22.75 10.00 2037.947 4125.763
2/Day 7 10JUN2020 8 196.69 97.41 21287.860 26546.329
2/Day 14 16JUN2020 14 575.80 278.05 15668.886 19928.873
2/1 Month 02JUL2020 30 155.32 57.93 6091.225 6217.432
C4591001 1001 10011019 1/Prevax 13MAY2020 1 10.00 10.00 BLQ BLQ
1/Day 7 19MAY2020 7 10.00 10.00 BLQ BLQ
1/Day 21 03JUN2020 22 32.90 10.00 1272.166 2131.917
2/Day 7 11JUN2020 9 457.56 195.66 13121.951 17536.909
090177e194f60646\Final\Final On: 19-Sep-2020 01:53 (GMT)
Page 10
FDA-CBER-2021-5683-0019456
16.2.6.1.1 Listing of Assay Data – Phase 1, 2 Doses, 21 Days Apar t
Assay
Vaccine
Candidate Age Group
(Years) Vaccine Group
(as Randomized) Subject Dose/
Sampling
Time Point Date of
Sample Rel
Daya NT50
(Titer) NT90
(Titer) S1-Binding
IgG Level
(U/mL) RBD -Binding
IgG Level
(U/mL)
2/Day 14 16JUN2020 14 286.03 123.05 6079.262 6187.334
2/1 Month 01JUL2020 29 90.03 29.44 3536.052 3698.276
C4591001 1001 10011020 1/Prevax 13MAY2020 1 10.00 10.00 BLQ BLQ
1/Day 7 19MAY2020 7 10.00 10.00 BLQ BLQ
1/Day 21 03JUN2020 22 10.00 10.00 289.225 826.447
2/Day 7 11JUN2020 9 99.23 37.78 13539.082 20163.971
2/Day 14 16JUN2020 14 188.11 80.78 9318.900 11935.137
2/1 Month 01JUL2020 29 26.91 10.00 4097.844 4095.031
C4591001 1001 10011024 1/Prevax 13MAY2020 1 10.00 10.00 BLQ BLQ
1/Day 7 19MAY2020 7 10.00 10.00 BLQ BLQ
1/Day 21 03JUN2020 22 38.51 10.00 1263.998 2422.869
2/Day 7 11JUN2020 9 649.45 303.68 48172.791 59494.662
2/Day 14 16JUN2020 14 677.23 279.88 21232.437 23145.657
2/1 Month 06JUL2020 34 233.19 110.86 10220.476 14093.480
C4591001 1002 10021006 1/Prevax 11MAY2020 1 10.00 10.00 BLQ BLQ
1/Day 7 18MAY2020 8 10.00 10.00 BLQ BLQ
090177e194f60646\Final\Final On: 19-Sep-2020 01:53 (GMT)
Page 11
FDA-CBER-2021-5683-0019457
16.2.6.1.1 Listing of Assay Data – Phase 1, 2 Doses, 21 Days Apar t
Assay
Vaccine
Candidate Age Group
(Years) Vaccine Group
(as Randomized) Subject Dose/
Sampling
Time Point Date of
Sample Rel
Daya NT50
(Titer) NT90
(Titer) S1-Binding
IgG Level
(U/mL) RBD -Binding
IgG Level
(U/mL)
1/Day 21 02JUN2020 23 13.57 10.00 223.098 628.904
2/Day 7 08JUN2020 7 127.98 70.90 10827.617 12316.982
2/Day 14 15JUN2020 14 152.21 62.52 6146.781 6525.494
2/1 Month 01JUL2020 30 84.29 39.06 3792.520 4821.409
C4591001 1002 10021014 1/Prevax 13MAY2020 1 10.00 10.00 BLQ BLQ
1/Day 7 19MAY2020 7 10.00 10.00 BLQ BLQ
1/Day 21 02JUN2020 21 55.98 10.00 1088.881 2505.039
2/Day 7 08JUN2020 7 372.12 195.43 32662.948 35114.871
2/Day 14 15JUN2020 14 836.85 384.38 39021.240 49086.835
2/1 Month 01JUL2020 30 414.57 161.95 17127.988 22281.587
C4591001 1002 10021015 1/Prevax 11MAY2020 1 10.00 10.00 BLQ BLQ
1/Day 7 18MAY2020 8 10.00 10.00 BLQ BLQ
1/Day 21 02JUN2020 23 10.00 10.00 202.808 339.855
2/Day 7 08JUN2020 7 97.72 45.75 12628.742 11501.245
2/Day 14 15JUN2020 14 380.32 179.73 14751.482 13240.274
2/1 Month 01JUL2020 30 272.07 107.54 10940.469 13669.687
090177e194f60646\Final\Final On: 19-Sep-2020 01:53 (GMT)
Page 12
FDA-CBER-2021-5683-0019458
16.2.6.1.1 Listing of Assay Data – Phase 1, 2 Doses, 21 Days Apar t
Assay
Vaccine
Candidate Age Group
(Years) Vaccine Group
(as Randomized) Subject Dose/
Sampling
Time Point Date of
Sample Rel
Daya NT50
(Titer) NT90
(Titer) S1-Binding
IgG Level
(U/mL) RBD -Binding
IgG Level
(U/mL)
C4591001 1002 10021017 1/Prevax 13MAY2020 1 10.00 10.00 1.347 4.568
1/Day 7 19MAY2020 7 10.00 10.00 BLQ 3.166
1/Day 21 02JUN2020 21 49.21 20.87 1003.317 1708.437
2/Day 7 08JUN2020 7 202.75 85.92 42963.372 49275.188
2/Day 14 15JUN2020 14 551.42 248.12 16911.023 19097.651
2/1 Month 01JUL2020 30 217.88
13078.361 16804.579
C4591001 1002 10021020 1/Prevax 13MAY2020 1 10.00 10.00 BLQ BLQ
1/Day 7 19MAY2020 7 10.00 10.00 BLQ BLQ
1/Day 21 02JUN2020 21 30.92 10.00 1057.099 1747.959
2/Day 7 08JUN2020 7 244.17 116.63 23119.446 24704.445
2/Day 14 15JUN2020 14 394.90 160.96 9557.209 12825.893
2/1 Month 01JUL2020 30 292.25 90.61 5958.097 13015.611
Placebo 18-55 Placebo C4591001 1001 10011005 1/Prevax 06MAY2020 1 11.58 10.00 BLQ BLQ
1/Day 7 12MAY2020 7 10.00 10.00 BLQ BLQ
1/Day 21 26MAY2020 21 11.57 10.00 BLQ BLQ
2/Day 7 02JUN2020 8 10.00 10.00 BLQ BLQ
090177e194f60646\Final\Final On: 19-Sep-2020 01:53 (GMT)
Page 13
FDA-CBER-2021-5683-0019459
16.2.6.1.1 Listing of Assay Data – Phase 1, 2 Doses, 21 Days Apar t
Assay
Vaccine
Candidate Age Group
(Years) Vaccine Group
(as Randomized) Subject Dose/
Sampling
Time Point Date of
Sample Rel
Daya NT50
(Titer) NT90
(Titer) S1-Binding
IgG Level
(U/mL) RBD -Binding
IgG Level
(U/mL)
2/Day 14 09JUN2020 15 10.00 10.00 BLQ BLQ
2/1 Month 25JUN2020 31 10.00 10.00 BLQ BLQ
C4591001 1001 10011066 1/Prevax 29JUN2020 1 10.00 10.00 BLQ BLQ
1/Day 21 20JUL2020 22 10.00 10.00 BLQ BLQ
2/Day 7 27JUL2020 8 10.00 10.00 BLQ BLQ
2/Day 14 03AUG2020 15 10.00 10.00 BLQ BLQ
2/1 Month 24AUG2020 36 10.00 10.00 BLQ BLQ
C4591001 1001 10011069 1/Prevax 01JUL2020 1 10.00 10.00 BLQ BLQ
1/Day 21 22JUL2020 22 10.00 10.00 BLQ BLQ
2/Day 7 29JUL2020 8 10.00 10.00 BLQ BLQ
2/Day 14 05AUG2020 15 10.00 10.00 BLQ BLQ
2/1 Month 21AUG2020 31 10.00 10.00 BLQ BLQ
C4591001 1002 10021005 1/Prevax 04MAY2020 1 10.00 10.00 10.589 BLQ
1/Day 7 11MAY2020 8 10.00 10.00 3.314 BLQ
1/Day 21 26MAY2020 23 10.00 10.00 8.209 2.201
2/Day 7 01JUN2020 7 10.00 10.00 10.036 1.455
090177e194f60646\Final\Final On: 19-Sep-2020 01:53 (GMT)
Page 14
FDA-CBER-2021-5683-0019460
16.2.6.1.1 Listing of Assay Data – Phase 1, 2 Doses, 21 Days Apar t
Assay
Vaccine
Candidate Age Group
(Years) Vaccine Group
(as Randomized) Subject Dose/
Sampling
Time Point Date of
Sample Rel
Daya NT50
(Titer) NT90
(Titer) S1-Binding
IgG Level
(U/mL) RBD -Binding
IgG Level
(U/mL)
2/Day 14 10JUN2020 16 10.00 10.00 10.302 BLQ
2/1 Month 29JUN2020 35 10.00 10.00 7.588 BLQ
C4591001 1002 10021008 1/Prevax 06MAY2020 1 10.00 10.00 BLQ 7.709
1/Day 7 12MAY2020 7 10.00 10.00 BLQ 4.026
1/Day 21 26MAY2020 21 10.00 10.00 BLQ 5.033
2/Day 7 01JUN2020 7 10.00 10.00 BLQ 3.292
2/Day 14 10JUN2020 16 10.00 10.00 BLQ 2.864
2/1 Month 29JUN2020 35 10.00 10.00 BLQ 4.878
C4591001 1002 10021018 1/Prevax 11MAY2020 1 10.00 10.00 1.749 BLQ
1/Day 7 18MAY2020 8 10.00 10.00 1.968 1.403
1/Day 21 02JUN2020 23 10.00 10.00 BLQ BLQ
2/Day 7 08JUN2020 7 10.00 10.00 3.650 1.799
2/Day 14 15JUN2020 14 10.00 10.00 1.320 BLQ
2/1 Month 01JUL2020 30 10.00 10.00 1.271 BLQ
C4591001 1002 10021021 1/Prevax 13MAY2020 1 10.00 10.00 BLQ BLQ
1/Day 7 19MAY2020 7 10.00 10.00 BLQ BLQ
090177e194f60646\Final\Final On: 19-Sep-2020 01:53 (GMT)
Page 15
FDA-CBER-2021-5683-0019461
16.2.6.1.1 Listing of Assay Data – Phase 1, 2 Doses, 21 Days Apar t
Assay
Vaccine
Candidate Age Group
(Years) Vaccine Group
(as Randomized) Subject Dose/
Sampling
Time Point Date of
Sample Rel
Daya NT50
(Titer) NT90
(Titer) S1-Binding
IgG Level
(U/mL) RBD -Binding
IgG Level
(U/mL)
1/Day 21 02JUN2020 21 10.00 10.00 BLQ BLQ
2/Day 7 08JUN2020 7 10.00 10.00 BLQ BLQ
2/Day 14 15JUN2020 14 10.00 10.00 BLQ BLQ
2/1 Month 01JUL2020 30 10.00 10.00 BLQ BLQ
C4591001 1002 10021022 1/Prevax 13MAY2020 1 10.00 10.00 BLQ BLQ
1/Day 7 19MAY2020 7 10.00 10.00 BLQ BLQ
1/Day 21 02JUN2020 21 10.00 10.00 BLQ BLQ
2/Day 7 08JUN2020 7 10.00 10.00 2.520 BLQ
2/Day 14 15JUN2020 14 10.00 10.00 BLQ BLQ
2/1 Month 01JUL2020 30 10.00 10.00 BLQ BLQ
C4591001 1002 10021083 1/Prevax 01JUL2020 1 10.00 10.00 BLQ BLQ
1/Day 21 21JUL2020 21 10.00 10.00 BLQ BLQ
2/Day 7 28JUL2020 8 10.00 10.00 BLQ BLQ
2/Day 14 04AUG2020 15 10.00 10.00 BLQ BLQ
2/1 Month 18AUG2020 29 10.00 10.00 BLQ BLQ
BNT162b1 65-85 10 μg C4591001 1001 10011037 1/Prevax 11JUN2020 1 10.00 10.00 BLQ BLQ
090177e194f60646\Final\Final On: 19-Sep-2020 01:53 (GMT)
Page 16
FDA-CBER-2021-5683-0019462
16.2.6.1.1 Listing of Assay Data – Phase 1, 2 Doses, 21 Days Apar t
Assay
Vaccine
Candidate Age Group
(Years) Vaccine Group
(as Randomized) Subject Dose/
Sampling
Time Point Date of
Sample Rel
Daya NT50
(Titer) NT90
(Titer) S1-Binding
IgG Level
(U/mL) RBD -Binding
IgG Level
(U/mL)
1/Day 21 30JUN2020 20 10.00 10.00 164.585 267.360
2/Day 7 06JUL2020 7 37.65 20.69 2021.639 2759.516
2/Day 14 14JUL2020 15 249.33 106.43 6537.000 10194.166
2/1 Month 30JUL2020 31 190.62 79.24 7879.601 8369.919
C4591001 1001 10011039 1/Prevax 09JUN2020 1 10.00 10.00 BLQ BLQ
1/Day 21 29JUN2020 21 10.00 10.00 15.375 18.400
2/Day 7 06JUL2020 8 10.00 10.00 748.984 1043.121
2/Day 14 13JUL2020 15 22.73 10.00 1454.075 1303.236
2/1 Month 27JUL2020 29 10.00 10.00 1171.576 1504.851
C4591001 1001 10011040 1/Prevax 11JUN2020 1 10.00 10.00 BLQ BLQ
1/Day 21 02JUL2020 22 34.67 10.00 391.706 596.633
2/Day 7 09JUL2020 8 116.06 39.29 3688.024 5580.544
2/Day 14 16JUL2020 15 122.85 41.06 4944.007 3445.803
2/1 Month 30JUL2020 29 107.90 27.76 3226.865 3930.287
C4591001 1001 10011041 1/Prevax 11JUN2020 1 10.00 10.00 BLQ BLQ
1/Day 21 02JUL2020 22 10.00 10.00 237.171 313.226
090177e194f60646\Final\Final On: 19-Sep-2020 01:53 (GMT)
Page 17
FDA-CBER-2021-5683-0019463
16.2.6.1.1 Listing of Assay Data – Phase 1, 2 Doses, 21 Days Apar t
Assay
Vaccine
Candidate Age Group
(Years) Vaccine Group
(as Randomized) Subject Dose/
Sampling
Time Point Date of
Sample Rel
Daya NT50
(Titer) NT90
(Titer) S1-Binding
IgG Level
(U/mL) RBD -Binding
IgG Level
(U/mL)
2/Day 7 09JUL2020 8 22.93 10.00 1326.068 1809.578
2/Day 14 16JUL2020 15 20.36 10.00 1586.531 1611.105
2/1 Month 31JUL2020 30 20.77 10.00 1553.119 1231.736
C4591001 1001 10011044 1/Prevax 09JUN2020 1 10.00 10.00 7.996 9.444
1/Day 21 29JUN2020 21 10.00 10.00 9.454 15.799
2/Day 7 06JUL2020 8 10.00 10.00 636.435 1181.486
2/Day 14 13JUL2020 15 10.00 10.00 1332.700 1966.678
2/1 Month 03AUG2020 36 10.00 10.00 694.382 1487.349
C4591001 1001 10011045 1/Prevax 11JUN2020 1 10.00 10.00 BLQ BLQ
1/Day 21 02JUL2020 22 10.00 10.00 50.184 56.534
2/Day 7 09JUL2020 8 21.33 10.00 1791.525 2020.295
2/Day 14 16JUL2020 15 10.00 10.00 1476.185 1691.997
2/1 Month 31JUL2020 30 24.53 10.00 1609.282 1595.508
C4591001 1002 10021043 1/Prevax 09JUN2020 1 10.00 10.00 BLQ 2.505
1/Day 21 30JUN2020 22 10.00 10.00 187.515 419.864
2/Day 7 07JUL2020 8 33.84 10.00 1202.695 2050.468
090177e194f60646\Final\Final On: 19-Sep-2020 01:53 (GMT)
Page 18
FDA-CBER-2021-5683-0019464
16.2.6.1.1 Listing of Assay Data – Phase 1, 2 Doses, 21 Days Apar t
Assay
Vaccine
Candidate Age Group
(Years) Vaccine Group
(as Randomized) Subject Dose/
Sampling
Time Point Date of
Sample Rel
Daya NT50
(Titer) NT90
(Titer) S1-Binding
IgG Level
(U/mL) RBD -Binding
IgG Level
(U/mL)
2/Day 14 14JUL2020 15 43.98 27.27 3439.375 5800.728
2/1 Month 28JUL2020 29 38.58 21.96 1596.338 2508.464
C4591001 1002 10021044 1/Prevax 09JUN2020 1 10.00 10.00 6.933 119.968
1/Day 21 30JUN2020 22 10.00 10.00 24.878 223.571
2/Day 7 07JUL2020 8 10.00 10.00 578.294 1212.396
2/Day 14 14JUL2020 15 10.00 10.00 643.051 980.336
2/1 Month 28JUL2020 29 10.00 10.00 403.494 908.690
C4591001 1002 10021045 1/Prevax 11JUN2020 1 10.00 10.00 BLQ BLQ
1/Day 21 30JUN2020 20 10.00 10.00 20.387 26.705
2/Day 7 07JUL2020 8 26.55 10.00 1620.411 2221.833
2/Day 14 14JUL2020 15 34.60 20.16 898.557 1078.819
2/1 Month 28JUL2020 29 10.00 10.00 581.964 946.263
C4591001 1002 10021049 1/Prevax 11JUN2020 1 10.00 10.00 BLQ BLQ
1/Day 21 30JUN2020 20 10.00 10.00 BLQ 1.266
2/Day 7 07JUL2020 8 10.00 10.00 30.622 33.419
2/Day 14 14JUL2020 15 10.00 10.00 249.081 330.889
090177e194f60646\Final\Final On: 19-Sep-2020 01:53 (GMT)
Page 19
FDA-CBER-2021-5683-0019465
16.2.6.1.1 Listing of Assay Data – Phase 1, 2 Doses, 21 Days Apar t
Assay
Vaccine
Candidate Age Group
(Years) Vaccine Group
(as Randomized) Subject Dose/
Sampling
Time Point Date of
Sample Rel
Daya NT50
(Titer) NT90
(Titer) S1-Binding
IgG Level
(U/mL) RBD -Binding
IgG Level
(U/mL)
2/1 Month 28JUL2020 29 10.00 10.00 221.700 263.711
C4591001 1002 10021052 1/Prevax 11JUN2020 1 10.00 10.00 BLQ BLQ
1/Day 21 30JUN2020 20 10.00 10.00 10.955 17.169
2/Day 7 07JUL2020 8 10.00 10.00 659.047 1216.351
2/Day 14 14JUL2020 15 46.46 10.00 740.587 1085.196
2/1 Month 28JUL2020 29 20.01 10.00 599.284 1016.089
C4591001 1002 10021053 1/Prevax 11JUN2020 1 10.00 10.00 BLQ BLQ
1/Day 21 30JUN2020 20 10.00 10.00 60.151 120.497
2/Day 7 07JUL2020 8 22.12 10.00 4081.545 4163.279
2/Day 14 14JUL2020 15 139.31 10.00 2998.702 3091.844
2/1 Month 28JUL2020 29 49.48 10.00 2221.877 3253.238
20 μg C4591001 1001 10011043 1/Prevax 15JUN2020 1 10.00 10.00 BLQ BLQ
1/Day 21 08JUL2020 24 10.00 10.00 227.449 329.497
2/Day 7 14JUL2020 7 204.55 112.12 12913.968 14728.623
2/Day 14 20JUL2020 13 64.93 36.99 6109.417 5845.042
2/1 Month 12AUG2020 36 133.51 57.95 5906.545 7014.835
090177e194f60646\Final\Final On: 19-Sep-2020 01:53 (GMT)
Page 20
FDA-CBER-2021-5683-0019466
16.2.6.1.1 Listing of Assay Data – Phase 1, 2 Doses, 21 Days Apar t
Assay
Vaccine
Candidate Age Group
(Years) Vaccine Group
(as Randomized) Subject Dose/
Sampling
Time Point Date of
Sample Rel
Daya NT50
(Titer) NT90
(Titer) S1-Binding
IgG Level
(U/mL) RBD -Binding
IgG Level
(U/mL)
C4591001 1001 10011049 1/Prevax 15JUN2020 1 10.00 10.00 BLQ BLQ
1/Day 21 06JUL2020 22 10.00 10.00 44.053 63.114
2/Day 7 13JUL2020 8 50.15 10.00 2524.353 2702.318
2/Day 14 20JUL2020 15 28.99 10.00 1611.504 1844.090
2/1 Month 03AUG2020 29 54.73 25.45 1369.923 1749.878
C4591001 1001 10011050 1/Prevax 17JUN2020 1 10.00 10.00 BLQ BLQ
1/Day 21 07JUL2020 21 10.00 10.00 45.044 97.947
2/Day 7 15JUL2020 9 35.91 10.00 2458.740 3871.011
2/Day 14 20JUL2020 14 10.00 10.00 2002.308 2145.200
2/1 Month 10AUG2020 35 46.84 10.00 1713.679 2135.461
C4591001 1001 10011052 1/Prevax 17JUN2020 1 10.00 10.00 BLQ BLQ
1/Day 21 08JUL2020 22 10.00 10.00 524.676 1282.584
2/Day 7 15JUL2020 8 341.22 203.96 20183.614 22529.567
2/Day 14 21JUL2020 14 244.90 99.06 16873.741 15125.704
2/1 Month 06AUG2020 30 283.15 143.10 16711.209 15924.161
C4591001 1001 10011055 1/Prevax 17JUN2020 1 10.00 10.00 BLQ BLQ
090177e194f60646\Final\Final On: 19-Sep-2020 01:53 (GMT)
Page 21
FDA-CBER-2021-5683-0019467
16.2.6.1.1 Listing of Assay Data – Phase 1, 2 Doses, 21 Days Apar t
Assay
Vaccine
Candidate Age Group
(Years) Vaccine Group
(as Randomized) Subject Dose/
Sampling
Time Point Date of
Sample Rel
Daya NT50
(Titer) NT90
(Titer) S1-Binding
IgG Level
(U/mL) RBD -Binding
IgG Level
(U/mL)
1/Day 21 08JUL2020 22 10.00 10.00 21.484 59.141
2/Day 7 15JUL2020 8 40.96 20.64 3395.333 4632.807
2/Day 14 23JUL2020 16 10.00 10.00 2324.409 3008.303
2/1 Month 06AUG2020 30 35.74 10.00 2547.931 2111.032
C4591001 1001 10011059 1/Prevax 17JUN2020 1 10.00 10.00 2.128 BLQ
1/Day 21 08JUL2020 22 10.00 10.00 482.432 663.179
2/Day 7 15JUL2020 8 623.82 267.48 36799.356 40244.557
2/Day 14 20JUL2020 13 213.27 124.73 24172.792 28930.696
2/1 Month 10AUG2020 34 429.78 204.92 29215.661 28835.436
C4591001 1002 10021054 1/Prevax 15JUN2020 1 10.00 10.00 BLQ BLQ
1/Day 21 07JUL2020 23 10.00 10.00 180.784 289.050
2/Day 7 15JUL2020 9 272.29 78.52 18247.360 20898.035
2/Day 14 22JUL2020 16 223.61 108.14 9339.999 9190.890
2/1 Month 05AUG2020 30 112.90 54.69 5990.732 6974.108
C4591001 1002 10021060 1/Prevax 15JUN2020 1 10.00 10.00 BLQ BLQ
1/Day 21 07JUL2020 23 10.00 10.00 92.691 165.415
090177e194f60646\Final\Final On: 19-Sep-2020 01:53 (GMT)
Page 22
FDA-CBER-2021-5683-0019468
16.2.6.1.1 Listing of Assay Data – Phase 1, 2 Doses, 21 Days Apar t
Assay
Vaccine
Candidate Age Group
(Years) Vaccine Group
(as Randomized) Subject Dose/
Sampling
Time Point Date of
Sample Rel
Daya NT50
(Titer) NT90
(Titer) S1-Binding
IgG Level
(U/mL) RBD -Binding
IgG Level
(U/mL)
2/Day 7 15JUL2020 9 318.36 125.57 24554.266 30489.683
2/Day 14 22JUL2020 16 209.29 97.46 12890.517 14440.699
2/1 Month 05AUG2020 30 203.65 84.57 8913.044 9804.130
C4591001 1002 10021064 1/Prevax 17JUN2020 1 10.00 10.00 BLQ BLQ
1/Day 21 08JUL2020 22 10.00 10.00 14.369 20.816
2/Day 7 16JUL2020 9 83.08 39.33 3272.403 4407.888
2/Day 14 23JUL2020 16 80.16 31.34 1752.413 2155.463
2/1 Month 06AUG2020 30 59.09 24.01 1442.641 1590.947
C4591001 1002 10021067 1/Prevax 17JUN2020 1 10.00 10.00 1.948 BLQ
1/Day 21 08JUL2020 22 10.00 10.00 619.299 1366.310
2/Day 7 16JUL2020 9 266.70 116.70 13599.713 16793.587
2/Day 14 22JUL2020 15 477.01 141.90 9426.292 9352.423
2/1 Month 05AUG2020 29 144.74 53.54 5003.457 5049.851
C4591001 1002 10021068 1/Prevax 17JUN2020 1 10.00 10.00 BLQ BLQ
1/Day 21 08JUL2020 22 10.00 10.00 238.210 523.670
2/Day 7 16JUL2020 9 450.22 218.74 19910.644 24642.300
090177e194f60646\Final\Final On: 19-Sep-2020 01:53 (GMT)
Page 23
FDA-CBER-2021-5683-0019469
16.2.6.1.1 Listing of Assay Data – Phase 1, 2 Doses, 21 Days Apar t
Assay
Vaccine
Candidate Age Group
(Years) Vaccine Group
(as Randomized) Subject Dose/
Sampling
Time Point Date of
Sample Rel
Daya NT50
(Titer) NT90
(Titer) S1-Binding
IgG Level
(U/mL) RBD -Binding
IgG Level
(U/mL)
2/Day 14 22JUL2020 15 584.97 101.86 12065.039 15774.422
2/1 Month 05AUG2020 29 340.13 133.59 9398.156 12112.956
C4591001 1002 10021071 1/Prevax 17JUN2020 1 10.00 10.00 BLQ BLQ
1/Day 21 08JUL2020 22 10.00 10.00 168.026 376.593
2/Day 7 16JUL2020 9 380.91 205.85 25724.924 29105.137
2/Day 14 23JUL2020 16 167.92 87.22 10517.534 10466.764
2/1 Month 06AUG2020 30 149.99 48.45 5419.457 6151.586
30 μg C4591001 1001 10011046 1/Prevax 18JUN2020 1 10.00 10.00 BLQ BLQ
1/Day 21 09JUL2020 22 10.00 10.00 89.965 182.803
2/Day 7 16JUL2020 8 87.73 21.51 3850.410 5206.308
2/Day 14 23JUL2020 15 85.96 40.79 2923.719 4804.912
2/1 Month 06AUG2020 29 88.16 39.54 5769.513 5045.108
C4591001 1001 10011048 1/Prevax 16JUN2020 1 10.00 10.00 1.817 BLQ
1/Day 21 08JUL2020 23 10.00 10.00 377.334 275.427
2/Day 7 15JUL2020 8 578.66 170.40 25752.846 26137.823
2/Day 14 22JUL2020 15 228.13 108.31 16781.340 17916.618
090177e194f60646\Final\Final On: 19-Sep-2020 01:53 (GMT)
Page 24
FDA-CBER-2021-5683-0019470
16.2.6.1.1 Listing of Assay Data – Phase 1, 2 Doses, 21 Days Apar t
Assay
Vaccine
Candidate Age Group
(Years) Vaccine Group
(as Randomized) Subject Dose/
Sampling
Time Point Date of
Sample Rel
Daya NT50
(Titer) NT90
(Titer) S1-Binding
IgG Level
(U/mL) RBD -Binding
IgG Level
(U/mL)
2/1 Month 05AUG2020 29 648.25 194.13 12500.480 12935.248
C4591001 1001 10011058 1/Prevax 18JUN2020 1 10.00 10.00 BLQ BLQ
1/Day 21 09JUL2020 22 43.12 10.00 1299.400 1352.806
2/Day 7 16JUL2020 8 500.33 263.43 41176.526 31973.127
2/Day 14 21JUL2020 13 613.05 173.48 26900.737 34222.863
2/1 Month 07AUG2020 30 462.49 228.08 31515.742 30626.736
C4591001 1001 10011061 1/Prevax 18JUN2020 1 10.00 10.00 BLQ BLQ
1/Day 21 09JUL2020 22 10.00 10.00 19.907 26.108
2/Day 7 16JUL2020 8 47.11 21.30 4803.773 4524.727
2/Day 14 21JUL2020 13 30.64 10.00 2785.277 3249.330
2/1 Month 07AUG2020 30 23.34 10.00 2988.543 3446.047
C4591001 1001 10011063 1/Prevax 18JUN2020 1 10.00 10.00 BLQ BLQ
1/Day 21 07JUL2020 20 10.00 10.00 624.652 1203.414
2/Day 7 13JUL2020 7 74.45 57.67 13768.869 15786.799
2/Day 14 23JUL2020 17 220.54 125.65 15813.539 18046.250
2/1 Month 07AUG2020 32 197.36 82.59 15188.310 18499.641
090177e194f60646\Final\Final On: 19-Sep-2020 01:53 (GMT)
Page 25
FDA-CBER-2021-5683-0019471
16.2.6.1.1 Listing of Assay Data – Phase 1, 2 Doses, 21 Days Apar t
Assay
Vaccine
Candidate Age Group
(Years) Vaccine Group
(as Randomized) Subject Dose/
Sampling
Time Point Date of
Sample Rel
Daya NT50
(Titer) NT90
(Titer) S1-Binding
IgG Level
(U/mL) RBD -Binding
IgG Level
(U/mL)
C4591001 1002 10021059 1/Prevax 15JUN2020 1 10.00 10.00 BLQ BLQ
1/Day 21 07JUL2020 23 10.00 10.00 1.527 4.406
2/Day 7 15JUL2020 9 10.00 10.00 518.685 885.514
2/Day 14 22JUL2020 16 10.00 10.00 404.145 540.111
2/1 Month 06AUG2020 31 21.95 10.00 320.448 399.586
C4591001 1002 10021062 1/Prevax 15JUN2020 1 10.00 10.00 BLQ BLQ
1/Day 21 07JUL2020 23 33.41 10.00 22.642 3.619
2/Day 7 15JUL2020 9 81.24 64.09 3713.960 4145.516
2/Day 14 22JUL2020 16 126.90 34.64 2010.189 3409.157
2/1 Month 06AUG2020 31 183.93 78.00 1542.529 1837.586
C4591001 1002 10021063 1/Prevax 15JUN2020 1 10.00 10.00 BLQ BLQ
1/Day 21 07JUL2020 23 10.00 10.00 111.597 130.258
2/Day 7 15JUL2020 9 230.16 117.42 10827.140 13524.969
2/Day 14 22JUL2020 16 84.07 50.40 5513.458 7505.717
2/1 Month 06AUG2020 31 238.79 73.32 3372.996 3678.428
C4591001 1002 10021069 1/Prevax 18JUN2020 1 10.00 10.00 BLQ BLQ
090177e194f60646\Final\Final On: 19-Sep-2020 01:53 (GMT)
Page 26
FDA-CBER-2021-5683-0019472
16.2.6.1.1 Listing of Assay Data – Phase 1, 2 Doses, 21 Days Apar t
Assay
Vaccine
Candidate Age Group
(Years) Vaccine Group
(as Randomized) Subject Dose/
Sampling
Time Point Date of
Sample Rel
Daya NT50
(Titer) NT90
(Titer) S1-Binding
IgG Level
(U/mL) RBD -Binding
IgG Level
(U/mL)
1/Day 21 08JUL2020 21 10.00 10.00 121.428 132.356
2/Day 7 16JUL2020 9 144.59 99.19 4889.669 5841.047
2/Day 14 23JUL2020 16 74.70 43.94 3513.768 3545.885
2/1 Month 06AUG2020 30 149.66 76.15 2739.998 3085.500
C4591001 1002 10021074 1/Prevax 18JUN2020 1 10.00 10.00 BLQ 1.450
1/Day 21 08JUL2020 21 10.00 10.00 135.085 186.568
2/Day 7 16JUL2020 9 38.00 10.00 3660.250 4570.714
2/Day 14 23JUL2020 16 108.31 35.85 5549.290 5999.251
2/1 Month 06AUG2020 30 104.69 57.33 3103.889 4204.020
C4591001 1002 10021075 1/Prevax 18JUN2020 1 10.00 10.00 BLQ BLQ
1/Day 21 08JUL2020 21 10.00 10.00 32.856 48.907
2/Day 7 16JUL2020 9 28.79 10.00 1486.266 1846.682
2/Day 14 23JUL2020 16 46.01
1644.088 1848.402
2/1 Month 06AUG2020 30 67.43 25.95 1483.822 1707.030
C4591001 1002 10021077 1/Prevax 18JUN2020 1 10.00 10.00 BLQ BLQ
1/Day 21 08JUL2020 21 10.00 10.00 149.227 168.781
090177e194f60646\Final\Final On: 19-Sep-2020 01:53 (GMT)
Page 27
FDA-CBER-2021-5683-0019473
16.2.6.1.1 Listing of Assay Data – Phase 1, 2 Doses, 21 Days Apar t
Assay
Vaccine
Candidate Age Group
(Years) Vaccine Group
(as Randomized) Subject Dose/
Sampling
Time Point Date of
Sample Rel
Daya NT50
(Titer) NT90
(Titer) S1-Binding
IgG Level
(U/mL) RBD -Binding
IgG Level
(U/mL)
2/Day 7 16JUL2020 9 417.18 152.24 43929.438 43505.518
2/Day 14 23JUL2020 16 587.39 195.27 17850.016 23487.514
2/1 Month 06AUG2020 30 681.33 228.01 12056.783 8774.756
Placebo 65-85 Placebo C4591001 1001 10011042 1/Prevax 11JUN2020 1 10.00 10.00 BLQ BLQ
1/Day 21 30JUN2020 20 10.00 10.00 BLQ BLQ
2/Day 7 07JUL2020 8 10.00 10.00 BLQ BLQ
2/Day 14 14JUL2020 15 10.00 10.00 BLQ BLQ
2/1 Month 03AUG2020 35 10.00 10.00 BLQ BLQ
C4591001 1001 10011053 1/Prevax 16JUN2020 1 10.00 10.00 1.905 BLQ
1/Day 21 09JUL2020 24 10.00 10.00 1.914 BLQ
2/Day 7 15JUL2020 7 10.00 10.00 4.130 1.247
2/Day 14 24JUL2020 16 10.00 10.00 BLQ 1.635
2/1 Month 07AUG2020 30 10.00 10.00 4.408 BLQ
C4591001 1001 10011057 1/Prevax 17JUN2020 1 10.00 10.00 6.203 32.020
1/Day 21 08JUL2020 22 10.00 10.00 6.241 28.303
2/Day 7 15JUL2020 8 10.00 10.00 13.746 54.951
090177e194f60646\Final\Final On: 19-Sep-2020 01:53 (GMT)
Page 28
FDA-CBER-2021-5683-0019474
16.2.6.1.1 Listing of Assay Data – Phase 1, 2 Doses, 21 Days Apar t
Assay
Vaccine
Candidate Age Group
(Years) Vaccine Group
(as Randomized) Subject Dose/
Sampling
Time Point Date of
Sample Rel
Daya NT50
(Titer) NT90
(Titer) S1-Binding
IgG Level
(U/mL) RBD -Binding
IgG Level
(U/mL)
2/Day 14 20JUL2020 13 10.00 10.00 4.265 25.881
2/1 Month 05AUG2020 29 10.00 10.00 5.519 26.660
C4591001 1001 10011064 1/Prevax 18JUN2020 1 10.00 10.00 BLQ BLQ
1/Day 21 07JUL2020 20 10.00 10.00 BLQ BLQ
2/Day 7 13JUL2020 7 10.00 10.00 BLQ BLQ
2/Day 14 23JUL2020 17 10.00 10.00 BLQ BLQ
2/1 Month 07AUG2020 32 10.00 10.00 BLQ BLQ
C4591001 1002 10021042 1/Prevax 09JUN2020 1 10.00 10.00 BLQ BLQ
1/Day 21 30JUN2020 22 10.00 10.00 BLQ BLQ
2/Day 7 07JUL2020 8 10.00 10.00 BLQ BLQ
2/Day 14 14JUL2020 15 10.00 10.00 BLQ BLQ
2/1 Month 28JUL2020 29 10.00 10.00 BLQ BLQ
C4591001 1002 10021047 1/Prevax 11JUN2020 1 10.00 10.00 3.152 9.664
1/Day 21 30JUN2020 20 10.00 10.00 4.054 7.323
2/Day 7 07JUL2020 8 10.00 10.00 3.046 9.119
2/Day 14 14JUL2020 15 10.00 10.00 3.024 10.792
090177e194f60646\Final\Final On: 19-Sep-2020 01:53 (GMT)
Page 29
FDA-CBER-2021-5683-0019475
16.2.6.1.1 Listing of Assay Data – Phase 1, 2 Doses, 21 Days Apar t
Assay
Vaccine
Candidate Age Group
(Years) Vaccine Group
(as Randomized) Subject Dose/
Sampling
Time Point Date of
Sample Rel
Daya NT50
(Titer) NT90
(Titer) S1-Binding
IgG Level
(U/mL) RBD -Binding
IgG Level
(U/mL)
2/1 Month 28JUL2020 29 10.00 10.00 3.479 11.559
C4591001 1002 10021050 1/Prevax 15JUN2020 1 10.00 10.00 BLQ BLQ
1/Day 21 07JUL2020 23 10.00 10.00 BLQ BLQ
2/Day 7 15JUL2020 9 10.00 10.00 BLQ BLQ
2/Day 14 22JUL2020 16 10.00 10.00 BLQ BLQ
2/1 Month 06AUG2020 31 10.00 10.00 BLQ BLQ
C4591001 1002 10021072 1/Prevax 18JUN2020 1 10.00 10.00 BLQ BLQ
1/Day 21 08JUL2020 21 10.00 10.00 BLQ BLQ
2/Day 7 16JUL2020 9 10.00 10.00 BLQ BLQ
2/Day 14 23JUL2020 16 10.00 10.00 BLQ BLQ
2/1 Month 06AUG2020 30 10.00 10.00 BLQ BLQ
C4591001 1002 10021073 1/Prevax 17JUN2020 1 10.00 10.00 BLQ BLQ
1/Day 21 08JUL2020 22 10.00 10.00 BLQ BLQ
2/Day 7 16JUL2020 9 10.00 10.00 BLQ BLQ
2/Day 14 23JUL2020 16 10.00 10.00 BLQ BLQ
2/1 Month 05AUG2020 29 10.00 10.00 BLQ BLQ
090177e194f60646\Final\Final On: 19-Sep-2020 01:53 (GMT)
Page 30
FDA-CBER-2021-5683-0019476
16.2.6.1.1 Listing of Assay Data – Phase 1, 2 Doses, 21 Days Apar t
Assay
Vaccine
Candidate Age Group
(Years) Vaccine Group
(as Randomized) Subject Dose/
Sampling
Time Point Date of
Sample Rel
Daya NT50
(Titer) NT90
(Titer) S1-Binding
IgG Level
(U/mL) RBD -Binding
IgG Level
(U/mL)
BNT162b2 18-55 10 μg C4591001 1003 10031018 1/Prevax 09JUN2020 1 10.00 10.00 BLQ BLQ
1/Day 21 30JUN2020 22 47.70 10.00 1048.113 647.226
2/Day 7 07JUL2020 8 383.49 150.59 10550.715 5867.989
2/Day 14 14JUL2020 15 214.56 102.37 5906.376 3807.309
2/1 Month 29JUL2020 30 196.34 79.59 4305.679 3883.614
C4591001 1003 10031019 1/Prevax 11JUN2020 1 10.00 10.00 BLQ BLQ
1/Day 21 02JUL2020 22 10.00 10.00 428.780 138.438
2/Day 7 09JUL2020 8 122.66 58.61 6553.673 4131.725
2/Day 14 15JUL2020 14 160.93 53.83 7104.758 4994.848
2/1 Month 30JUL2020 29 182.80 78.02 5120.373 3773.569
C4591001 1003 10031020 1/Prevax 11JUN2020 1 10.00 10.00 BLQ BLQ
1/Day 21 02JUL2020 22 10.00 10.00 438.578 270.187
2/Day 7 09JUL2020 8 263.25 110.75 6045.168 6333.483
2/Day 14 16JUL2020 15 242.93 76.40 5911.150 4639.018
2/1 Month 04AUG2020 34 314.41 84.29 3891.556 3060.121
C4591001 1003 10031021 1/Prevax 09JUN2020 1 10.00 10.00 1.335 BLQ
090177e194f60646\Final\Final On: 19-Sep-2020 01:53 (GMT)
Page 31
FDA-CBER-2021-5683-0019477
16.2.6.1.1 Listing of Assay Data – Phase 1, 2 Doses, 21 Days Apar t
Assay
Vaccine
Candidate Age Group
(Years) Vaccine Group
(as Randomized) Subject Dose/
Sampling
Time Point Date of
Sample Rel
Daya NT50
(Titer) NT90
(Titer) S1-Binding
IgG Level
(U/mL) RBD -Binding
IgG Level
(U/mL)
1/Day 21 30JUN2020 22 10.00 10.00 615.617 258.606
2/Day 7 07JUL2020 8 69.13 32.64 3749.016 3169.250
2/Day 14 14JUL2020 15 26.53 10.00 4290.581 2878.158
2/1 Month 31JUL2020 32 42.02 10.00 2390.980 1619.258
C4591001 1003 10031022 1/Prevax 11JUN2020 1 10.00 10.00 BLQ BLQ
1/Day 21 02JUL2020 22 89.33 25.50 1758.467 960.214
2/Day 7 09JUL2020 8 444.88 148.54 8558.783 6805.330
2/Day 14 14JUL2020 13 51.50 32.53 10233.041 9254.158
2/1 Month 30JUL2020 29 82.45 41.34 4863.036 4142.828
C4591001 1003 10031024 1/Prevax 11JUN2020 1 10.00 10.00 BLQ BLQ
1/Day 21 02JUL2020 22 10.00 10.00 491.959 191.524
2/Day 7 09JUL2020 8 65.65 33.57 1772.740 1299.095
2/Day 14 16JUL2020 15 26.41 10.00 922.505 544.129
2/1 Month 04AUG2020 34 66.72 10.00 1076.822 711.023
C4591001 1007 10071014 1/Prevax 11JUN2020 1 10.00 10.00 BLQ BLQ
1/Day 21 01JUL2020 21 10.00 10.00 444.590 252.826
090177e194f60646\Final\Final On: 19-Sep-2020 01:53 (GMT)
Page 32
FDA-CBER-2021-5683-0019478
16.2.6.1.1 Listing of Assay Data – Phase 1, 2 Doses, 21 Days Apar t
Assay
Vaccine
Candidate Age Group
(Years) Vaccine Group
(as Randomized) Subject Dose/
Sampling
Time Point Date of
Sample Rel
Daya NT50
(Titer) NT90
(Titer) S1-Binding
IgG Level
(U/mL) RBD -Binding
IgG Level
(U/mL)
2/Day 7 08JUL2020 8 74.99 20.71 4633.287 6192.209
2/Day 14 15JUL2020 15 134.18 39.93 2785.945 2132.208
2/1 Month 03AUG2020 34 114.49 10.00 2017.252 1647.340
C4591001 1007 10071015 1/Prevax 08JUN2020 1 10.00 10.00 BLQ 2.426
1/Day 21 29JUN2020 22 10.00 10.00 240.326 141.240
2/Day 7 07JUL2020 9 124.99 42.26 5623.339 5839.955
2/Day 14 13JUL2020 15 48.43 28.44 4534.153 5213.778
2/1 Month 27JUL2020 29 282.59 138.36 3533.782 2870.816
C4591001 1007 10071016 1/Prevax 10JUN2020 1 10.00 10.00 BLQ BLQ
1/Day 21 01JUL2020 22 25.89 10.00 1465.017 1068.672
2/Day 7 08JUL2020 8 180.94 92.42 7065.358 4752.924
2/Day 14 15JUL2020 15 58.50 22.55 4685.655 4171.522
2/1 Month 29JUL2020 29 47.82 25.32 2339.706 2047.983
C4591001 1007 10071019 1/Prevax 08JUN2020 1 10.00 10.00 BLQ BLQ
1/Day 21 29JUN2020 22 10.00 10.00 608.357 266.876
2/Day 7 06JUL2020 8 93.96 46.29 5860.589 4746.550
090177e194f60646\Final\Final On: 19-Sep-2020 01:53 (GMT)
Page 33
FDA-CBER-2021-5683-0019479
16.2.6.1.1 Listing of Assay Data – Phase 1, 2 Doses, 21 Days Apar t
Assay
Vaccine
Candidate Age Group
(Years) Vaccine Group
(as Randomized) Subject Dose/
Sampling
Time Point Date of
Sample Rel
Daya NT50
(Titer) NT90
(Titer) S1-Binding
IgG Level
(U/mL) RBD -Binding
IgG Level
(U/mL)
2/Day 14 13JUL2020 15 82.65 62.16 5228.351 5573.149
2/1 Month 27JUL2020 29 41.08 33.96 3391.452 3930.210
C4591001 1007 10071021 1/Prevax 10JUN2020 1 10.00 10.00 BLQ BLQ
1/Day 21 01JUL2020 22 10.00 10.00 111.694 77.815
2/Day 7 08JUL2020 8 103.01 48.30 3302.852 2427.150
2/Day 14 15JUL2020 15 1075.04 346.82 2831.818 2655.640
2/1 Month 29JUL2020 29 82.98 10.00 1354.140 1242.715
C4591001 1007 10071022 1/Prevax 10JUN2020 1 10.00 10.00 BLQ BLQ
1/Day 21 01JUL2020 22 23.18 10.00 2473.273 1921.339
2/Day 7 08JUL2020 8 541.57 226.41 16471.473 15445.508
2/Day 14 15JUL2020 15 65.91 29.53 13778.539 13192.440
2/1 Month 29JUL2020 29 54.13 31.01 7345.879 6193.573
20 μg C4591001 1003 10031026 1/Prevax 17JUN2020 1 10.00 10.00 1.799 1.502
1/Day 21 08JUL2020 22 70.72 23.01 633.109 370.018
2/Day 7 15JUL2020 8 257.87 73.84 9291.099 6361.636
2/Day 14 24JUL2020 17 193.88 89.81 3574.902 3621.121
090177e194f60646\Final\Final On: 19-Sep-2020 01:53 (GMT)
Page 34
FDA-CBER-2021-5683-0019480
16.2.6.1.1 Listing of Assay Data – Phase 1, 2 Doses, 21 Days Apar t
Assay
Vaccine
Candidate Age Group
(Years) Vaccine Group
(as Randomized) Subject Dose/
Sampling
Time Point Date of
Sample Rel
Daya NT50
(Titer) NT90
(Titer) S1-Binding
IgG Level
(U/mL) RBD -Binding
IgG Level
(U/mL)
2/1 Month 05AUG2020 29 374.03 83.27 3284.990 2407.056
C4591001 1003 10031027 1/Prevax 15JUN2020 1 10.00 10.00 BLQ BLQ
1/Day 21 06JUL2020 22 10.00 10.00 852.214 530.235
2/Day 7 13JUL2020 8 196.28 99.89 5871.804 6083.199
2/Day 14 20JUL2020 15 231.25 58.89 4277.122 5316.147
2/1 Month 04AUG2020 30 243.07 42.48 2744.998 2342.667
C4591001 1003 10031028 1/Prevax 15JUN2020 1 10.00 10.00 BLQ BLQ
1/Day 21 06JUL2020 22 76.72 10.00 2125.452 1507.648
2/Day 7 13JUL2020 8 832.59 316.29 19259.605 24118.918
2/Day 14 20JUL2020 15 536.53 182.73 12124.378 8633.085
C4591001 1003 10031030 1/Prevax 17JUN2020 1 10.00 10.00 BLQ BLQ
1/Day 21 08JUL2020 22 10.00 10.00 232.357 158.402
2/Day 7 16JUL2020 9 654.81 209.59 8917.821 8589.061
2/Day 14 21JUL2020 14 241.06 101.82 4284.956 4264.053
2/1 Month 11AUG2020 35 172.62 60.75 4447.300 3806.675
C4591001 1003 10031032 1/Prevax 17JUN2020 1 10.00 10.00 8.605 BLQ
090177e194f60646\Final\Final On: 19-Sep-2020 01:53 (GMT)
Page 35
FDA-CBER-2021-5683-0019481
16.2.6.1.1 Listing of Assay Data – Phase 1, 2 Doses, 21 Days Apar t
Assay
Vaccine
Candidate Age Group
(Years) Vaccine Group
(as Randomized) Subject Dose/
Sampling
Time Point Date of
Sample Rel
Daya NT50
(Titer) NT90
(Titer) S1-Binding
IgG Level
(U/mL) RBD -Binding
IgG Level
(U/mL)
1/Day 21 08JUL2020 22 10.00 10.00 269.076 224.526
2/Day 7 15JUL2020 8 501.84 200.03 27468.740 24751.814
2/Day 14 22JUL2020 15 1000.07 331.59 25113.043 17648.378
2/1 Month 05AUG2020 29 1410.72 287.42 11795.493 5529.235
C4591001 1003 10031038 1/Prevax 17JUN2020 1 10.00 10.00 BLQ BLQ
1/Day 21 08JUL2020 22 42.67 10.00 850.242 564.229
2/Day 7 14JUL2020 7 539.29 122.00 14247.629 15095.897
2/Day 14 20JUL2020 13 1339.03 346.43 17639.449 15299.529
2/1 Month 11AUG2020 35 674.30 197.19 11850.546 13382.369
C4591001 1007 10071017 1/Prevax 15JUN2020 1 10.00 10.00 BLQ BLQ
1/Day 21 06JUL2020 22 10.00 10.00 475.318 349.754
2/Day 7 13JUL2020 8 165.54 92.55 10035.667 12178.164
2/Day 14 20JUL2020 15 207.59 90.58 5015.482 5304.225
2/1 Month 03AUG2020 29 134.92 46.63 3644.675 2871.720
C4591001 1007 10071023 1/Prevax 17JUN2020 1 10.00 10.00 BLQ BLQ
1/Day 21 08JUL2020 22 22.60 10.00 1193.195 494.786
090177e194f60646\Final\Final On: 19-Sep-2020 01:53 (GMT)
Page 36
FDA-CBER-2021-5683-0019482
16.2.6.1.1 Listing of Assay Data – Phase 1, 2 Doses, 21 Days Apar t
Assay
Vaccine
Candidate Age Group
(Years) Vaccine Group
(as Randomized) Subject Dose/
Sampling
Time Point Date of
Sample Rel
Daya NT50
(Titer) NT90
(Titer) S1-Binding
IgG Level
(U/mL) RBD -Binding
IgG Level
(U/mL)
2/Day 7 15JUL2020 8 347.23 115.64 14024.422 14223.975
2/Day 14 22JUL2020 15 178.16 87.05 4714.396 4528.604
2/1 Month 05AUG2020 29 94.67 10.00 6766.606 4547.393
C4591001 1007 10071026 1/Prevax 15JUN2020 1 10.00 10.00 BLQ BLQ
1/Day 21 06JUL2020 22 39.65 10.00 563.898 485.877
2/Day 7 13JUL2020 8 576.55 266.39 15393.444 12025.406
2/Day 14 21JUL2020 16 183.99 101.97 7685.526 5297.550
2/1 Month 03AUG2020 29 254.87 52.01 5761.892 3491.914
C4591001 1007 10071027 1/Prevax 17JUN2020 1 10.00 10.00 BLQ BLQ
1/Day 21 08JUL2020 22 10.00 10.00 690.334 323.236
2/Day 7 15JUL2020 8 440.37 240.83 23937.985 22534.553
2/Day 14 22JUL2020 15 392.45 176.45 17545.870 12668.113
2/1 Month 05AUG2020 29 393.90 68.76 9890.325 5956.001
C4591001 1007 10071029 1/Prevax 17JUN2020 1 10.00 10.00 BLQ BLQ
1/Day 21 08JUL2020 22 10.00 10.00 215.318 133.177
2/Day 7 15JUL2020 8 251.75 96.93 9520.346 12603.956
090177e194f60646\Final\Final On: 19-Sep-2020 01:53 (GMT)
Page 37
FDA-CBER-2021-5683-0019483
16.2.6.1.1 Listing of Assay Data – Phase 1, 2 Doses, 21 Days Apar t
Assay
Vaccine
Candidate Age Group
(Years) Vaccine Group
(as Randomized) Subject Dose/
Sampling
Time Point Date of
Sample Rel
Daya NT50
(Titer) NT90
(Titer) S1-Binding
IgG Level
(U/mL) RBD -Binding
IgG Level
(U/mL)
2/Day 14 22JUL2020 15 186.86 66.03 5284.421 4784.455
2/1 Month 05AUG2020 29 117.79 47.96 6043.788 4134.824
C4591001 1007 10071040 1/Prevax 17JUN2020 1 10.00 10.00 BLQ BLQ
1/Day 21 08JUL2020 22 10.00 10.00 246.188 142.661
2/Day 7 15JUL2020 8 187.71 85.93 7763.192 6494.694
2/Day 14 22JUL2020 15 99.42 39.54 4309.586 3100.367
2/1 Month 05AUG2020 29 113.83 37.42 5097.742 3852.929
30 μg C4591001 1003 10031057 1/Prevax 24JUN2020 1 10.00 10.00 BLQ BLQ
1/Day 21 15JUL2020 22 10.00 10.00 1785.167 1445.632
2/Day 7 23JUL2020 9 123.84 54.83 4187.834 4472.036
2/Day 14 29JUL2020 15 77.60 32.58 4901.716 3916.322
2/1 Month 14AUG2020 31 75.48 47.62 2531.690 3158.296
C4591001 1003 10031059 1/Prevax 24JUN2020 1 10.00 10.00 BLQ 2.152
1/Day 21 15JUL2020 22 38.51 25.20 2387.360 2316.414
2/Day 7 22JUL2020 8 593.97 263.99 13665.452 11528.386
2/Day 14 29JUL2020 15 164.72 47.79 8356.274 5715.104
090177e194f60646\Final\Final On: 19-Sep-2020 01:53 (GMT)
Page 38
FDA-CBER-2021-5683-0019484
16.2.6.1.1 Listing of Assay Data – Phase 1, 2 Doses, 21 Days Apar t
Assay
Vaccine
Candidate Age Group
(Years) Vaccine Group
(as Randomized) Subject Dose/
Sampling
Time Point Date of
Sample Rel
Daya NT50
(Titer) NT90
(Titer) S1-Binding
IgG Level
(U/mL) RBD -Binding
IgG Level
(U/mL)
2/1 Month 12AUG2020 29 197.82 103.60 9069.142 9995.020
C4591001 1003 10031061 1/Prevax 22JUN2020 1 10.00 10.00 BLQ 1.764
1/Day 21 13JUL2020 22 24.12 10.00 2034.200 1472.357
2/Day 7 20JUL2020 8 475.10 215.27 14871.221 11493.221
2/Day 14 27JUL2020 15 101.81 33.24 8177.560 8972.178
2/1 Month 10AUG2020 29 125.92 33.58 4777.738 4374.206
C4591001 1003 10031065 1/Prevax 24JUN2020 1 10.00 10.00 BLQ 1.375
1/Day 21 15JUL2020 22 10.00 10.00 1077.345 753.801
2/Day 7 22JUL2020 8 382.79 111.51 12189.072 10010.250
2/Day 14 29JUL2020 15 312.35 63.03 10857.081 15028.622
2/1 Month 19AUG2020 36 270.09 97.00 6680.664 4932.820
C4591001 1003 10031066 1/Prevax 22JUN2020 1 10.00 10.00 BLQ BLQ
1/Day 21 13JUL2020 22 25.57 10.00 1234.764 1046.822
2/Day 7 20JUL2020 8 646.10 212.70 10245.536 7195.399
2/Day 14 27JUL2020 15 209.47 108.45 8304.566 5696.671
2/1 Month 13AUG2020 32 168.37 64.55 6535.662 4987.115
090177e194f60646\Final\Final On: 19-Sep-2020 01:53 (GMT)
Page 39
FDA-CBER-2021-5683-0019485
16.2.6.1.1 Listing of Assay Data – Phase 1, 2 Doses, 21 Days Apar t
Assay
Vaccine
Candidate Age Group
(Years) Vaccine Group
(as Randomized) Subject Dose/
Sampling
Time Point Date of
Sample Rel
Daya NT50
(Titer) NT90
(Titer) S1-Binding
IgG Level
(U/mL) RBD -Binding
IgG Level
(U/mL)
C4591001 1003 10031072 1/Prevax 24JUN2020 1 10.00 10.00 BLQ BLQ
1/Day 21 16JUL2020 23 10.00 10.00 872.910 585.865
2/Day 7 23JUL2020 8 227.94 59.30 5493.313 4335.537
2/Day 14 30JUL2020 15 148.60 68.26 5728.804 6083.396
2/1 Month 19AUG2020 35 111.43 43.33 3216.962 2800.247
C4591001 1007 10071046 1/Prevax 22JUN2020 1 10.00 10.00 BLQ 3.633
1/Day 21 15JUL2020 24 10.00 10.00 543.918 306.779
2/Day 7 22JUL2020 8 208.52 76.21 5258.850 4840.530
2/1 Month 10AUG2020 27 83.42 31.68 5448.022 4328.844
C4591001 1007 10071050 1/Prevax 22JUN2020 1 10.00 10.00 BLQ 4.552
1/Day 21 13JUL2020 22 10.00 10.00 1947.042 1466.357
2/Day 7 16JUL2020 4 10.00 10.00 2303.297 2048.654
2/Day 14 27JUL2020 15 181.55 77.83 14534.819 11412.326
2/1 Month 10AUG2020 29 129.83 75.35 9931.257 9844.396
C4591001 1007 10071058 1/Prevax 24JUN2020 1 10.00 10.00 BLQ BLQ
1/Day 21 15JUL2020 22 33.30 10.00 2349.640 1267.727
090177e194f60646\Final\Final On: 19-Sep-2020 01:53 (GMT)
Page 40
FDA-CBER-2021-5683-0019486
16.2.6.1.1 Listing of Assay Data – Phase 1, 2 Doses, 21 Days Apar t
Assay
Vaccine
Candidate Age Group
(Years) Vaccine Group
(as Randomized) Subject Dose/
Sampling
Time Point Date of
Sample Rel
Daya NT50
(Titer) NT90
(Titer) S1-Binding
IgG Level
(U/mL) RBD -Binding
IgG Level
(U/mL)
2/Day 7 22JUL2020 8 956.07 382.07 15147.790 12613.040
2/1 Month 12AUG2020 29 298.37 77.13 5873.677 5816.177
C4591001 1007 10071063 1/Prevax 24JUN2020 1 10.00 10.00 BLQ BLQ
1/Day 21 15JUL2020 22 10.00 10.00 1279.126 395.676
2/Day 7 22JUL2020 8 215.12 72.00 6001.524 4552.661
2/Day 14 29JUL2020 15 118.70 45.72 9118.227 6635.440
2/1 Month 19AUG2020 36 82.51 41.16 5869.388 5107.530
C4591001 1007 10071064 1/Prevax 24JUN2020 1 10.00 10.00 BLQ BLQ
1/Day 21 15JUL2020 22 10.00 10.00 588.493 476.580
2/Day 7 22JUL2020 8 598.77 97.11 20251.294 18206.680
2/Day 14 29JUL2020 15 368.74 111.01 8650.637 5723.846
2/1 Month 12AUG2020 29 213.86 73.99 7225.490 7551.056
C4591001 1007 10071066 1/Prevax 24JUN2020 1 10.00 10.00 BLQ BLQ
1/Day 21 15JUL2020 22 10.00 10.00 889.173 689.837
2/Day 7 22JUL2020 8 267.65 107.30 6550.095 6558.525
2/Day 14 29JUL2020 15 135.66 33.45 6494.003 8095.554
090177e194f60646\Final\Final On: 19-Sep-2020 01:53 (GMT)
Page 41
FDA-CBER-2021-5683-0019487
16.2.6.1.1 Listing of Assay Data – Phase 1, 2 Doses, 21 Days Apar t
Assay
Vaccine
Candidate Age Group
(Years) Vaccine Group
(as Randomized) Subject Dose/
Sampling
Time Point Date of
Sample Rel
Daya NT50
(Titer) NT90
(Titer) S1-Binding
IgG Level
(U/mL) RBD -Binding
IgG Level
(U/mL)
2/1 Month 12AUG2020 29 128.06 38.94 4396.021 6025.496
Placebo 18-55 Placebo C4591001 1003 10031016 1/Prevax 09JUN2020 1 10.00 10.00 BLQ BLQ
1/Day 21 30JUN2020 22 10.00 10.00 BLQ 1.992
2/Day 7 07JUL2020 8 10.00 10.00 BLQ 1.725
2/Day 14 14JUL2020 15 10.00 10.00 BLQ 1.210
2/1 Month 03AUG2020 35 10.00 10.00 BLQ 1.487
C4591001 1003 10031017 1/Prevax 11JUN2020 1 10.00 10.00 BLQ BLQ
1/Day 21 02JUL2020 22 10.00 10.00 BLQ BLQ
2/Day 7 09JUL2020 8 10.00 10.00 BLQ BLQ
2/Day 14 16JUL2020 15 10.00 10.00 2.533 BLQ
2/1 Month 06AUG2020 36 10.00 10.00 BLQ BLQ
C4591001 1003 10031029 1/Prevax 15JUN2020 1 10.00 10.00 BLQ BLQ
1/Day 21 06JUL2020 22 10.00 10.00 BLQ BLQ
2/Day 7 13JUL2020 8 10.00 10.00 BLQ BLQ
2/Day 14 22JUL2020 17 10.00 10.00 BLQ BLQ
2/1 Month 10AUG2020 36 10.00 10.00 BLQ BLQ
090177e194f60646\Final\Final On: 19-Sep-2020 01:53 (GMT)
Page 42
FDA-CBER-2021-5683-0019488
16.2.6.1.1 Listing of Assay Data – Phase 1, 2 Doses, 21 Days Apar t
Assay
Vaccine
Candidate Age Group
(Years) Vaccine Group
(as Randomized) Subject Dose/
Sampling
Time Point Date of
Sample Rel
Daya NT50
(Titer) NT90
(Titer) S1-Binding
IgG Level
(U/mL) RBD -Binding
IgG Level
(U/mL)
C4591001 1003 10031034 1/Prevax 17JUN2020 1 10.00 10.00 BLQ 1.608
1/Day 21 08JUL2020 22 10.00 10.00 BLQ 1.318
2/Day 7 15JUL2020 8 10.00 10.00 BLQ 2.996
2/Day 14 20JUL2020 13 10.00 10.00 BLQ 3.138
2/1 Month 11AUG2020 35 10.00 10.00 BLQ 5.773
C4591001 1003 10031050 1/Prevax 22JUN2020 1 10.00 10.00 BLQ BLQ
1/Day 21 13JUL2020 22 10.00 10.00 BLQ BLQ
2/Day 7 20JUL2020 8 10.00 10.00 BLQ BLQ
2/Day 14 27JUL2020 15 10.00 10.00 BLQ BLQ
2/1 Month 13AUG2020 32 10.00 10.00 BLQ BLQ
C4591001 1003 10031070 1/Prevax 24JUN2020 1 10.00 10.00 1.822 BLQ
1/Day 21 15JUL2020 22 10.00 10.00 1.914 1.487
2/Day 7 23JUL2020 9 10.00 10.00 BLQ BLQ
2/Day 14 27JUL2020 13 10.00 10.00 BLQ BLQ
2/1 Month 12AUG2020 29 10.00 10.00 1.376 BLQ
C4591001 1007 10071020 1/Prevax 10JUN2020 1 10.00 10.00 BLQ BLQ
090177e194f60646\Final\Final On: 19-Sep-2020 01:53 (GMT)
Page 43
FDA-CBER-2021-5683-0019489
16.2.6.1.1 Listing of Assay Data – Phase 1, 2 Doses, 21 Days Apar t
Assay
Vaccine
Candidate Age Group
(Years) Vaccine Group
(as Randomized) Subject Dose/
Sampling
Time Point Date of
Sample Rel
Daya NT50
(Titer) NT90
(Titer) S1-Binding
IgG Level
(U/mL) RBD -Binding
IgG Level
(U/mL)
1/Day 21 01JUL2020 22 10.00 10.00 BLQ BLQ
2/Day 7 08JUL2020 8 10.00 10.00 BLQ BLQ
2/Day 14 15JUL2020 15 10.00 10.00 BLQ BLQ
2/1 Month 29JUL2020 29 10.00 10.00 2.441 BLQ
C4591001 1007 10071025 1/Prevax 17JUN2020 1 10.00 10.00 BLQ BLQ
1/Day 21 08JUL2020 22 10.00 10.00 BLQ BLQ
2/Day 7 15JUL2020 8 10.00 10.00 BLQ BLQ
2/Day 14 22JUL2020 15 10.00 10.00 BLQ BLQ
2/1 Month 05AUG2020 29 10.00 10.00 BLQ BLQ
C4591001 1007 10071065 1/Prevax 24JUN2020 1 10.00 10.00 BLQ 1.927
1/Day 21 15JUL2020 22 10.00 10.00 BLQ 1.912
2/Day 7 22JUL2020 8 10.00 10.00 BLQ BLQ
2/Day 14 29JUL2020 15 10.00 10.00 BLQ 1.504
2/1 Month 12AUG2020 29 10.00 10.00 BLQ 1.172
BNT162b2 65-85 10 μg C4591001 1003 10031076 1/Prevax 29JUN2020 1 10.00 10.00 BLQ BLQ
1/Day 21 20JUL2020 22 10.00 10.00 76.629 46.491
090177e194f60646\Final\Final On: 19-Sep-2020 01:53 (GMT)
Page 44
FDA-CBER-2021-5683-0019490
16.2.6.1.1 Listing of Assay Data – Phase 1, 2 Doses, 21 Days Apar t
Assay
Vaccine
Candidate Age Group
(Years) Vaccine Group
(as Randomized) Subject Dose/
Sampling
Time Point Date of
Sample Rel
Daya NT50
(Titer) NT90
(Titer) S1-Binding
IgG Level
(U/mL) RBD -Binding
IgG Level
(U/mL)
2/Day 7 27JUL2020 8 65.61 29.77 1581.004 1209.119
2/Day 14 03AUG2020 15 149.68 67.73 1361.463 1039.674
2/1 Month 18AUG2020 30 34.91 10.00 1421.579 1098.970
C4591001 1003 10031077 1/Prevax 01JUL2020 1 10.00 10.00 BLQ BLQ
1/Day 21 22JUL2020 22 10.00 10.00 209.271 163.788
2/Day 7 29JUL2020 8 50.77 37.16 5839.153 4376.381
2/Day 14 05AUG2020 15 93.01 56.38 4246.447 3687.991
2/1 Month 19AUG2020 29 65.77 20.00 2531.517 3176.089
C4591001 1003 10031078 1/Prevax 01JUL2020 1 10.00 10.00 BLQ BLQ
1/Day 21 22JUL2020 22 10.00 10.00 36.052 BLQ
2/Day 7 29JUL2020 8 32.00 10.00 1468.692 1199.488
2/Day 14 07AUG2020 17 44.36 10.00 3091.886 3048.264
2/1 Month 19AUG2020 29 26.32 10.00 1793.079 1663.693
C4591001 1003 10031079 1/Prevax 01JUL2020 1 10.00 10.00 BLQ BLQ
1/Day 21 22JUL2020 22 10.00 10.00 220.394 82.039
2/Day 7 29JUL2020 8 104.68 50.29 3891.367 1856.595
090177e194f60646\Final\Final On: 19-Sep-2020 01:53 (GMT)
Page 45
FDA-CBER-2021-5683-0019491
16.2.6.1.1 Listing of Assay Data – Phase 1, 2 Doses, 21 Days Apar t
Assay
Vaccine
Candidate Age Group
(Years) Vaccine Group
(as Randomized) Subject Dose/
Sampling
Time Point Date of
Sample Rel
Daya NT50
(Titer) NT90
(Titer) S1-Binding
IgG Level
(U/mL) RBD -Binding
IgG Level
(U/mL)
2/Day 14 05AUG2020 15 166.05 79.64 3065.311 1822.047
2/1 Month 19AUG2020 29 82.06 20.80 1747.737 1359.053
C4591001 1003 10031080 1/Prevax 29JUN2020 1 10.00 10.00 BLQ 2.992
1/Day 21 20JUL2020 22 10.00 10.00 1343.198 1118.328
2/Day 7 27JUL2020 8 469.84 158.89 7718.335 12314.100
2/Day 14 03AUG2020 15 190.18 122.50 11820.663 8713.343
2/1 Month 20AUG2020 32 452.53 137.17 6158.699 5629.456
C4591001 1003 10031087 1/Prevax 01JUL2020 1 10.00 10.00 2.332 3.690
1/Day 21 22JUL2020 22 10.00 10.00 100.404 62.707
2/Day 7 29JUL2020 8 44.06 30.15 2763.546 1865.768
2/Day 14 05AUG2020 15 87.03 63.51 1826.225 1466.120
2/1 Month 21AUG2020 31 47.91 10.00 1725.109 1218.025
C4591001 1007 10071051 1/Prevax 29JUN2020 1 10.00 10.00 BLQ BLQ
1/Day 21 20JUL2020 22 10.00 10.00 84.381 56.041
2/Day 7 27JUL2020 8 101.61 45.56 2803.623 2141.719
2/Day 14 03AUG2020 15 119.58 64.35 2672.440 2364.506
090177e194f60646\Final\Final On: 19-Sep-2020 01:53 (GMT)
Page 46
FDA-CBER-2021-5683-0019492
16.2.6.1.1 Listing of Assay Data – Phase 1, 2 Doses, 21 Days Apar t
Assay
Vaccine
Candidate Age Group
(Years) Vaccine Group
(as Randomized) Subject Dose/
Sampling
Time Point Date of
Sample Rel
Daya NT50
(Titer) NT90
(Titer) S1-Binding
IgG Level
(U/mL) RBD -Binding
IgG Level
(U/mL)
2/1 Month 17AUG2020 29 76.19 23.48 1660.555 1983.264
C4591001 1007 10071057 1/Prevax 30JUN2020 1 10.00 10.00 1.784 2.643
1/Day 21 22JUL2020 23 10.00 10.00 341.100 211.137
2/Day 7 29JUL2020 8 85.89 59.98 3693.782 3362.682
2/Day 14 05AUG2020 15 137.31 67.08 5203.493 5021.839
2/1 Month 20AUG2020 30 66.51 31.68 2942.620 3283.336
C4591001 1007 10071071 1/Prevax 29JUN2020 1 10.00 10.00 BLQ BLQ
1/Day 21 20JUL2020 22 10.00 10.00 132.178 76.626
2/Day 7 27JUL2020 8 84.63 29.92 2423.740 1832.613
2/Day 14 03AUG2020 15 112.21 41.25 2396.919 2134.165
2/1 Month 17AUG2020 29 36.33 10.00 1996.840 1918.232
C4591001 1007 10071073 1/Prevax 30JUN2020 1 10.00 10.00 BLQ 1.241
1/Day 21 22JUL2020 23 10.00 10.00 77.677 88.608
2/Day 7 29JUL2020 8 39.15 31.76 2189.738 1619.589
2/Day 14 05AUG2020 15 56.53 34.56 2939.285 3239.887
2/1 Month 20AUG2020 30 51.33 21.43 1896.095 2570.172
090177e194f60646\Final\Final On: 19-Sep-2020 01:53 (GMT)
Page 47
FDA-CBER-2021-5683-0019493
16.2.6.1.1 Listing of Assay Data – Phase 1, 2 Doses, 21 Days Apar t
Assay
Vaccine
Candidate Age Group
(Years) Vaccine Group
(as Randomized) Subject Dose/
Sampling
Time Point Date of
Sample Rel
Daya NT50
(Titer) NT90
(Titer) S1-Binding
IgG Level
(U/mL) RBD -Binding
IgG Level
(U/mL)
C4591001 1007 10071074 1/Prevax 30JUN2020 1 10.00 10.00 BLQ BLQ
1/Day 21 20JUL2020 21 10.00 10.00 271.213 207.969
2/Day 7 27JUL2020 8 68.76 38.06 3360.855 2242.195
2/1 Month 24AUG2020 36 79.52 20.79 3409.605 2442.125
C4591001 1007 10071077 1/Prevax 30JUN2020 1 10.00 10.00 BLQ BLQ
1/Day 21 22JUL2020 23 10.00 10.00 487.613 276.686
2/Day 7 29JUL2020 8 135.40 63.67 5614.140 5097.042
2/Day 14 05AUG2020 15 179.54 116.56 10051.138 6391.194
2/1 Month 19AUG2020 29 160.05 48.81 3763.612 3278.529
20 μg C4591001 1003 10031031 1/Prevax 15JUN2020 1 10.00 10.00 BLQ BLQ
1/Day 21 06JUL2020 22 10.00 10.00 105.209 64.720
2/Day 7 14JUL2020 9 159.88 95.71 4391.938 4950.455
2/Day 14 21JUL2020 16 308.84 63.99 3775.173 2652.662
2/1 Month 06AUG2020 32 82.13 33.54 1795.678 1245.275
C4591001 1003 10031035 1/Prevax 15JUN2020 1 10.00 10.00 BLQ BLQ
1/Day 21 06JUL2020 22 10.00 10.00 89.757 47.208
090177e194f60646\Final\Final On: 19-Sep-2020 01:53 (GMT)
Page 48
FDA-CBER-2021-5683-0019494
16.2.6.1.1 Listing of Assay Data – Phase 1, 2 Doses, 21 Days Apar t
Assay
Vaccine
Candidate Age Group
(Years) Vaccine Group
(as Randomized) Subject Dose/
Sampling
Time Point Date of
Sample Rel
Daya NT50
(Titer) NT90
(Titer) S1-Binding
IgG Level
(U/mL) RBD -Binding
IgG Level
(U/mL)
2/Day 7 14JUL2020 9 78.69 34.76 6293.608 3948.217
2/Day 14 20JUL2020 15 21.83 10.00 3057.317 2304.051
2/1 Month 06AUG2020 32 26.84 10.00 1471.485 1236.963
C4591001 1003 10031053 1/Prevax 17JUN2020 1 10.00 10.00 BLQ 3.743
1/Day 21 08JUL2020 22 10.00 10.00 154.468 155.896
2/Day 7 14JUL2020 7 47.93 25.64 1509.934 1611.926
2/Day 14 21JUL2020 14 154.80 35.22 2811.633 2209.674
2/1 Month 10AUG2020 34 87.70 49.57 3461.397 3412.112
C4591001 1003 10031054 1/Prevax 17JUN2020 1 10.00 10.00 BLQ BLQ
1/Day 21 08JUL2020 22 10.00 10.00 29.527 13.142
2/Day 7 16JUL2020 9 87.02 10.00 2081.464 2897.118
2/Day 14 23JUL2020 16 58.55 25.80 1208.723 889.154
2/1 Month 05AUG2020 29 63.46 39.25 1030.791 792.951
C4591001 1003 10031055 1/Prevax 17JUN2020 1 10.00 10.00 BLQ BLQ
1/Day 21 06JUL2020 20 10.00 10.00 223.685 164.963
2/Day 7 15JUL2020 10 153.55 65.21 10390.616 8135.746
090177e194f60646\Final\Final On: 19-Sep-2020 01:53 (GMT)
Page 49
FDA-CBER-2021-5683-0019495
16.2.6.1.1 Listing of Assay Data – Phase 1, 2 Doses, 21 Days Apar t
Assay
Vaccine
Candidate Age Group
(Years) Vaccine Group
(as Randomized) Subject Dose/
Sampling
Time Point Date of
Sample Rel
Daya NT50
(Titer) NT90
(Titer) S1-Binding
IgG Level
(U/mL) RBD -Binding
IgG Level
(U/mL)
2/Day 14 20JUL2020 15 214.09 60.20 4687.811 4477.302
2/1 Month 07AUG2020 33 170.73 74.64 4967.094 3831.820
C4591001 1003 10031063 1/Prevax 17JUN2020 1 10.00 10.00 6.477 BLQ
1/Day 21 08JUL2020 22 10.00 10.00 246.966 142.687
2/Day 7 15JUL2020 8 167.98 68.75 6267.706 5913.788
2/Day 14 21JUL2020 14 224.63 71.57 5089.808 3891.548
2/1 Month 05AUG2020 29 280.75 98.36 2312.339 1718.830
C4591001 1007 10071031 1/Prevax 17JUN2020 1 10.00 10.00 BLQ BLQ
1/Day 21 08JUL2020 22 10.00 10.00 1.860 BLQ
2/Day 7 15JUL2020 8 10.00 10.00 107.299 49.074
2/Day 14 22JUL2020 15 10.00 10.00 195.235 93.846
2/1 Month 05AUG2020 29 10.00 10.00 98.254 70.440
C4591001 1007 10071032 1/Prevax 15JUN2020 1 10.00 10.00 1.455 5.408
1/Day 21 06JUL2020 22 10.00 10.00 15.038 8.240
2/Day 7 13JUL2020 8 23.79 10.00 1496.409 1118.982
2/Day 14 20JUL2020 15 24.31 10.00 740.369 479.726
090177e194f60646\Final\Final On: 19-Sep-2020 01:53 (GMT)
Page 50
FDA-CBER-2021-5683-0019496
16.2.6.1.1 Listing of Assay Data – Phase 1, 2 Doses, 21 Days Apar t
Assay
Vaccine
Candidate Age Group
(Years) Vaccine Group
(as Randomized) Subject Dose/
Sampling
Time Point Date of
Sample Rel
Daya NT50
(Titer) NT90
(Titer) S1-Binding
IgG Level
(U/mL) RBD -Binding
IgG Level
(U/mL)
2/1 Month 05AUG2020 31 10.00 10.00 383.228 279.397
C4591001 1007 10071035 1/Prevax 15JUN2020 1 10.00 10.00 BLQ BLQ
1/Day 21 06JUL2020 22 10.00 10.00 164.041 120.913
2/Day 7 13JUL2020 8 362.66 116.29 6867.843 7086.875
2/Day 14 22JUL2020 17 482.76 148.34 12067.245 6112.915
2/1 Month 03AUG2020 29 305.43 119.95 6142.159 5693.419
C4591001 1007 10071038 1/Prevax 17JUN2020 1 10.00 10.00 BLQ BLQ
1/Day 21 08JUL2020 22 10.00 10.00 305.049 233.297
2/Day 7 15JUL2020 8 104.69 45.63 5434.431 6252.259
2/Day 14 22JUL2020 15 48.70 25.72 5913.398 3931.992
2/1 Month 05AUG2020 29 32.00 10.00 4150.530 4165.519
C4591001 1007 10071039 1/Prevax 17JUN2020 1 10.00 10.00 BLQ BLQ
1/Day 21 08JUL2020 22 10.00 10.00 178.369 163.391
2/Day 7 15JUL2020 8 128.47 66.89 4667.558 5012.738
2/Day 14 22JUL2020 15 47.66 27.63 3794.208 3025.739
2/1 Month 05AUG2020 29 47.49 26.14 1693.046 1563.573
090177e194f60646\Final\Final On: 19-Sep-2020 01:53 (GMT)
Page 51
FDA-CBER-2021-5683-0019497
16.2.6.1.1 Listing of Assay Data – Phase 1, 2 Doses, 21 Days Apar t
Assay
Vaccine
Candidate Age Group
(Years) Vaccine Group
(as Randomized) Subject Dose/
Sampling
Time Point Date of
Sample Rel
Daya NT50
(Titer) NT90
(Titer) S1-Binding
IgG Level
(U/mL) RBD -Binding
IgG Level
(U/mL)
C4591001 1007 10071052 1/Prevax 17JUN2020 1 10.00 10.00 BLQ BLQ
1/Day 21 08JUL2020 22 10.00 10.00 132.878 94.991
2/Day 7 15JUL2020 8 75.77 27.29 4192.875 4847.691
2/Day 14 20JUL2020 13 92.54 31.18 3370.258 2785.921
2/1 Month 05AUG2020 29 27.79 10.00 2293.269 2700.905
30 μg C4591001 1003 10031037 1/Prevax 16JUN2020 1 10.00 10.00 BLQ 1.513
1/Day 21 07JUL2020 22 34.83 10.00 2180.820 2004.880
2/Day 7 14JUL2020 8 733.17 250.39 31661.223 30209.881
2/Day 14 22JUL2020 16 1478.55 415.63 25344.514 29549.649
2/1 Month 07AUG2020 32 571.01 171.54 23292.845 22144.452
C4591001 1003 10031047 1/Prevax 16JUN2020 1 10.00 10.00 BLQ BLQ
1/Day 21 07JUL2020 22 10.00 10.00 1688.232 1653.611
2/Day 7 14JUL2020 8 89.71 39.92 14838.394 13004.121
2/Day 14 21JUL2020 15 136.67 52.32 8244.450 6211.746
2/1 Month 07AUG2020 32 104.51 58.23 12166.241 8407.283
C4591001 1003 10031051 1/Prevax 18JUN2020 1 10.00 10.00 BLQ BLQ
090177e194f60646\Final\Final On: 19-Sep-2020 01:53 (GMT)
Page 52
FDA-CBER-2021-5683-0019498
16.2.6.1.1 Listing of Assay Data – Phase 1, 2 Doses, 21 Days Apar t
Assay
Vaccine
Candidate Age Group
(Years) Vaccine Group
(as Randomized) Subject Dose/
Sampling
Time Point Date of
Sample Rel
Daya NT50
(Titer) NT90
(Titer) S1-Binding
IgG Level
(U/mL) RBD -Binding
IgG Level
(U/mL)
1/Day 21 09JUL2020 22 10.00 10.00 270.239 143.530
2/Day 7 15JUL2020 7 105.53 31.85 4751.043 3831.136
2/Day 14 22JUL2020 14 523.27 156.18 7153.760 6963.194
2/1 Month 12AUG2020 35 343.26 114.73 4352.603 3391.480
C4591001 1003 10031058 1/Prevax 18JUN2020 1 10.00 10.00 BLQ BLQ
1/Day 21 09JUL2020 22 10.00 10.00 19.576 7.490
2/Day 7 16JUL2020 8 49.33 10.00 3564.700 3235.166
2/Day 14 23JUL2020 15 42.15 10.00 1918.154 1694.248
2/1 Month 06AUG2020 29 69.86 20.08 2106.577 1640.525
C4591001 1003 10031069 1/Prevax 18JUN2020 1 10.00 10.00 BLQ BLQ
1/Day 21 09JUL2020 22 10.00 10.00 57.541 18.883
2/Day 7 16JUL2020 8 84.81 26.22 2837.681 2857.384
2/Day 14 23JUL2020 15 71.50
2113.166 2494.578
2/1 Month 10AUG2020 33 50.80 24.73 2856.606 2257.029
C4591001 1007 10071034 1/Prevax 15JUN2020 1 10.00 10.00 BLQ BLQ
1/Day 21 06JUL2020 22 10.00 10.00 191.290 177.041
090177e194f60646\Final\Final On: 19-Sep-2020 01:53 (GMT)
Page 53
FDA-CBER-2021-5683-0019499
16.2.6.1.1 Listing of Assay Data – Phase 1, 2 Doses, 21 Days Apar t
Assay
Vaccine
Candidate Age Group
(Years) Vaccine Group
(as Randomized) Subject Dose/
Sampling
Time Point Date of
Sample Rel
Daya NT50
(Titer) NT90
(Titer) S1-Binding
IgG Level
(U/mL) RBD -Binding
IgG Level
(U/mL)
2/Day 7 13JUL2020 8 177.31 91.01 5569.445 4547.872
2/Day 14 20JUL2020 15 110.75 48.76 5620.483 3599.563
2/1 Month 03AUG2020 29 154.99 41.80 5194.560 3036.658
C4591001 1007 10071037 1/Prevax 15JUN2020 1 10.00 10.00 BLQ BLQ
1/Day 21 06JUL2020 22 10.00 10.00 661.947 512.791
2/Day 7 13JUL2020 8 238.06 121.66 11873.094 8862.438
2/Day 14 20JUL2020 15 225.90 83.28 7179.096 5335.702
2/1 Month 05AUG2020 31 170.05 79.92 6252.281 5504.514
C4591001 1007 10071043 1/Prevax 18JUN2020 1 10.00 10.00 BLQ BLQ
1/Day 21 09JUL2020 22 10.00 10.00 344.012 388.020
2/Day 7 16JUL2020 8 202.08 77.39 12975.360 9471.675
2/Day 14 23JUL2020 15 506.40 148.36 9531.233 10877.869
2/1 Month 06AUG2020 29 434.60 137.57 6808.143 5809.250
C4591001 1007 10071044 1/Prevax 18JUN2020 1 10.00 10.00 BLQ BLQ
1/Day 21 09JUL2020 22 21.67 10.00 1276.247 862.675
2/Day 7 16JUL2020 8 785.88 177.18 17614.882 13195.801
090177e194f60646\Final\Final On: 19-Sep-2020 01:53 (GMT)
Page 54
FDA-CBER-2021-5683-0019500
16.2.6.1.1 Listing of Assay Data – Phase 1, 2 Doses, 21 Days Apar t
Assay
Vaccine
Candidate Age Group
(Years) Vaccine Group
(as Randomized) Subject Dose/
Sampling
Time Point Date of
Sample Rel
Daya NT50
(Titer) NT90
(Titer) S1-Binding
IgG Level
(U/mL) RBD -Binding
IgG Level
(U/mL)
2/Day 14 23JUL2020 15 398.65 135.98 8124.788 9659.014
2/1 Month 06AUG2020 29 446.18 72.60 6769.744 6389.172
C4591001 1007 10071045 1/Prevax 18JUN2020 1 10.00 10.00 BLQ BLQ
1/Day 21 09JUL2020 22 10.00 10.00 308.218 178.054
2/Day 7 16JUL2020 8 160.90 66.93 11319.677 5784.286
2/Day 14 23JUL2020 15 115.58 39.35 5952.028 5947.690
2/1 Month 06AUG2020 29 69.81 35.07 3679.260 2341.533
C4591001 1007 10071049 1/Prevax 18JUN2020 1 10.00 10.00 BLQ BLQ
1/Day 21 09JUL2020 22 10.00 10.00 157.137 222.163
2/Day 7 15JUL2020 7 32.34 10.00 1754.865 1664.955
2/Day 14 23JUL2020 15 310.31 10.00 3687.509 3534.434
2/1 Month 06AUG2020 29 47.67 10.00 1970.511 1239.494
C4591001 1007 10071053 1/Prevax 18JUN2020 1 10.00 10.00 BLQ BLQ
1/Day 21 09JUL2020 22 10.00 10.00 525.076 388.365
2/Day 7 16JUL2020 8 115.66 47.97 9916.289 5568.455
2/Day 14 23JUL2020 15 102.78 30.15 5387.397 4998.443
090177e194f60646\Final\Final On: 19-Sep-2020 01:53 (GMT)
Page 55
FDA-CBER-2021-5683-0019501
16.2.6.1.1 Listing of Assay Data – Phase 1, 2 Doses, 21 Days Apar t
Assay
Vaccine
Candidate Age Group
(Years) Vaccine Group
(as Randomized) Subject Dose/
Sampling
Time Point Date of
Sample Rel
Daya NT50
(Titer) NT90
(Titer) S1-Binding
IgG Level
(U/mL) RBD -Binding
IgG Level
(U/mL)
2/1 Month 06AUG2020 29 86.22 51.79 2893.851 1746.192
Placebo 65-85 Placebo C4591001 1003 10031036 1/Prevax 15JUN2020 1 10.00 10.00 BLQ BLQ
1/Day 21 06JUL2020 22 10.00 10.00 BLQ 4.780
2/Day 7 13JUL2020 8 10.00 10.00 1.373 7.140
2/Day 14 20JUL2020 15 10.00 10.00 BLQ 8.442
2/1 Month 10AUG2020 36 10.00 10.00 1.551 5.283
C4591001 1003 10031043 1/Prevax 16JUN2020 1 10.00 10.00 BLQ 3.975
1/Day 21 07JUL2020 22 10.00 10.00 BLQ 5.028
2/Day 7 14JUL2020 8 10.00 10.00 BLQ 4.340
2/Day 14 21JUL2020 15 10.00 10.00 BLQ 2.501
C4591001 1003 10031046 1/Prevax 18JUN2020 1 10.00 10.00 BLQ 1.223
1/Day 21 09JUL2020 22 10.00 10.00 BLQ 1.341
2/Day 7 16JUL2020 8 10.00 10.00 BLQ 2.930
2/Day 14 23JUL2020 15 10.00 10.00 BLQ 1.776
2/1 Month 10AUG2020 33 10.00 10.00 BLQ 2.618
C4591001 1003 10031056 1/Prevax 18JUN2020 1 10.00 10.00 1.591 BLQ
090177e194f60646\Final\Final On: 19-Sep-2020 01:53 (GMT)
Page 56
FDA-CBER-2021-5683-0019502
16.2.6.1.1 Listing of Assay Data – Phase 1, 2 Doses, 21 Days Apar t
Assay
Vaccine
Candidate Age Group
(Years) Vaccine Group
(as Randomized) Subject Dose/
Sampling
Time Point Date of
Sample Rel
Daya NT50
(Titer) NT90
(Titer) S1-Binding
IgG Level
(U/mL) RBD -Binding
IgG Level
(U/mL)
1/Day 21 09JUL2020 22 10.00 10.00 1.809 BLQ
2/Day 7 16JUL2020 8 10.00 10.00 3.887 BLQ
2/Day 14 23JUL2020 15 10.00 10.00 1.875 BLQ
2/1 Month 06AUG2020 29 10.00 10.00 2.550 BLQ
C4591001 1003 10031067 1/Prevax 17JUN2020 1 10.00 10.00 BLQ BLQ
1/Day 21 08JUL2020 22 10.00 10.00 BLQ BLQ
2/Day 7 16JUL2020 9 10.00 10.00 BLQ BLQ
2/Day 14 21JUL2020 14 10.00 10.00 BLQ BLQ
2/1 Month 06AUG2020 30 10.00 10.00 BLQ BLQ
C4591001 1003 10031083 1/Prevax 01JUL2020 1 10.00 10.00 1.937 1.247
1/Day 21 22JUL2020 22 10.00 10.00 2.163 BLQ
2/Day 7 30JUL2020 9 10.00 10.00 1.470 BLQ
2/Day 14 06AUG2020 16 10.00 10.00 1.529 BLQ
2/1 Month 20AUG2020 30 10.00 10.00 BLQ BLQ
C4591001 1007 10071042 1/Prevax 17JUN2020 1 10.00 10.00 BLQ BLQ
1/Day 21 08JUL2020 22 10.00 10.00 BLQ BLQ
090177e194f60646\Final\Final On: 19-Sep-2020 01:53 (GMT)
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16.2.6.1.1 Listing of Assay Data – Phase 1, 2 Doses, 21 Days Apar t
Assay
Vaccine
Candidate Age Group
(Years) Vaccine Group
(as Randomized) Subject Dose/
Sampling
Time Point Date of
Sample Rel
Daya NT50
(Titer) NT90
(Titer) S1-Binding
IgG Level
(U/mL) RBD -Binding
IgG Level
(U/mL)
2/Day 7 15JUL2020 8 10.00 10.00 BLQ BLQ
2/Day 14 22JUL2020 15 10.00 10.00 BLQ BLQ
2/1 Month 05AUG2020 29 10.00 10.00 BLQ BLQ
C4591001 1007 10071056 1/Prevax 29JUN2020 1 10.00 10.00 BLQ BLQ
1/Day 21 20JUL2020 22 10.00 10.00 BLQ BLQ
2/Day 7 27JUL2020 8 10.00 10.00 BLQ BLQ
2/Day 14 03AUG2020 15 10.00 10.00 BLQ BLQ
2/1 Month 17AUG2020 29 10.00 10.00 BLQ BLQ
C4591001 1007 10071075 1/Prevax 30JUN2020 1 10.00 10.00 BLQ BLQ
1/Day 21 22JUL2020 23 10.00 10.00 BLQ BLQ
2/Day 7 29JUL2020 8 10.00 10.00 BLQ BLQ
2/Day 14 05AUG2020 15 10.00 10.00 BLQ BLQ
2/1 Month 20AUG2020 30 10.00 10.00 BLQ BLQ
Abbreviations: IgG = immunoglobulin G; BLQ = below the limit of quantitation; NT50 = 50% neutralizing titer; NT90 = 90% neutr alizing titer;
RBD = receptor -binding domain; S1 = spike protein S1 subunit.
a. Relative Day (Rel Day) = date of blood draw - date of last vaccination + 1.
090177e194f60646\Final\Final On: 19-Sep-2020 01:53 (GMT)
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16.2.6.1.1 Listing of Assay Data – Phase 1, 2 Doses, 21 Days Apar t
Assay
Vaccine
Candidate Age Group
(Years) Vaccine Group
(as Randomized) Subject Dose/
Sampling
Time Point Date of
Sample Rel
Daya NT50
(Titer) NT90
(Titer) S1-Binding
IgG Level
(U/mL) RBD -Binding
IgG Level
(U/mL)
PFIZER CONFIDENTIAL SDTM Creation: 17SEP2020 (22:01) Source Data: adva Table Generation: 17SEP2020 (23:28)
(Cutoff Date: 24AUG2020, Snapshot Date: 17SEP2020) Output File: ./nda3/C4591001_IA_P1_Serology/adva_l001_p1
090177e194f60646\Final\Final On: 19-Sep-2020 01:53 (GMT)
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16.2.6.1.1.1 Listing of Assay Data Before Dose 2 – Phase 1 – BNT162b1 (100 μg )
Assay
Vaccine
Candidate Age Group
(Years) Vaccine Group
(as Randomized) Subject Dose/
Sampling
Time Point Date of
Sample Rel
Daya NT50
(Titer) NT90
(Titer) S1-Binding
IgG Level
(U/mL) RBD -Binding
IgG Level
(U/mL)
BNT162b1 18-55 100 μg C4591001 1001 10011026 1/Prevax 18MAY2020 1 10.00 10.00 BLQ BLQ
1/1 Week 26MAY2020 9 10.00 10.00 BLQ BLQ
1/3 Weeks 08JUN2020 22 40.58 10.00 643.635 1351.673
1/4 Weeks 15JUN2020 29
582.071 779.256
1/5 Weeks 22JUN2020 36 10.00 10.00 492.430 731.154
1/7 Weeks 13JUL2020 57 10.00 10.00 297.579 409.009
C4591001 1001 10011028 1/Prevax 20MAY2020 1 10.00 10.00 BLQ BLQ
1/1 Week 28MAY2020 9 10.00 10.00 BLQ BLQ
1/3 Weeks 10JUN2020 22 45.28 10.00 1182.138 1997.708
1/4 Weeks 17JUN2020 29
2921.157 4048.878
1/5 Weeks 26JUN2020 38 10.00 10.00 1250.738 1690.854
1/7 Weeks 09JUL2020 51 10.00 10.00 586.482 883.498
C4591001 1001 10011030 1/Prevax 20MAY2020 1 10.00 10.00 BLQ BLQ
1/1 Week 28MAY2020 9 10.00 10.00 BLQ 1.258
1/3 Weeks 10JUN2020 22 10.00 10.00 873.342 1498.225
1/4 Weeks 17JUN2020 29
1017.482 1082.017
1/5 Weeks 23JUN2020 35 10.00 10.00 454.864 666.417
1/7 Weeks 08JUL2020 50 10.00 10.00 105.443 171.111
C4591001 1001 10011032 1/Prevax 20MAY2020 1 10.00 10.00 BLQ BLQ
1/1 Week 28MAY2020 9 10.00 10.00 BLQ BLQ
1/3 Weeks 10JUN2020 22 26.98 10.00 662.226 1461.893
1/4 Weeks 17JUN2020 29
816.066 1147.268
1/5 Weeks 24JUN2020 36 10.00 10.00 346.081 593.048
1/7 Weeks 09JUL2020 51 10.00 10.00 263.937 472.095
C4591001 1001 10011034 1/Prevax 20MAY2020 1 10.00 10.00 BLQ BLQ
1/1 Week 28MAY2020 9 10.00 10.00 BLQ 1.499
090177e194ffe59c\Final\Final On: 24-Sep-2020 03:39 (GMT)
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16.2.6.1.1.1 Listing of Assay Data Before Dose 2 – Phase 1 – BNT162b1 (100 μg )
Assay
Vaccine
Candidate Age Group
(Years) Vaccine Group
(as Randomized) Subject Dose/
Sampling
Time Point Date of
Sample Rel
Daya NT50
(Titer) NT90
(Titer) S1-Binding
IgG Level
(U/mL) RBD -Binding
IgG Level
(U/mL)
1/3 Weeks 10JUN2020 22 84.72 33.29 4317.529 5641.114
1/4 Weeks 17JUN2020 29
3841.491 4621.444
1/5 Weeks 23JUN2020 35 10.00 10.00 1425.136 1967.796
1/7 Weeks 09JUL2020 51 10.00 10.00 595.236 856.362
C4591001 1002 10021023 1/Prevax 18MAY2020 1 10.00 10.00 BLQ BLQ
1/1 Week 26MAY2020 9 10.00 10.00 BLQ BLQ
1/3 Weeks 08JUN2020 22 45.20 10.00 1501.649 2450.494
1/4 Weeks 16JUN2020 30
842.097 1029.725
1/5 Weeks 23JUN2020 37 10.00 10.00 848.499 995.081
1/7 Weeks 09JUL2020 53 10.00 10.00 545.586 591.924
C4591001 1002 10021024 1/Prevax 18MAY2020 1 10.00 10.00 BLQ 3.675
1/1 Week 26MAY2020 9 10.00 10.00 BLQ 4.720
1/3 Weeks 10JUN2020 24 196.48 78.23 1961.375 3038.023
1/4 Weeks 16JUN2020 30
1959.503 2270.500
1/5 Weeks 22JUN2020 36 70.03 24.82 1011.718 1557.507
1/7 Weeks 09JUL2020 53 34.36 10.00 705.069 1181.020
C4591001 1002 10021027 1/Prevax 18MAY2020 1 10.00 10.00 BLQ 1.797
1/1 Week 26MAY2020 9 10.00 10.00 BLQ 1.642
1/3 Weeks 08JUN2020 22 111.02 51.33 1396.923 1839.490
1/4 Weeks 16JUN2020 30
704.323 1153.153
1/5 Weeks 23JUN2020 37 37.59 27.70 629.768 904.716
1/7 Weeks 09JUL2020 53 22.76 10.00 358.390 441.387
C4591001 1002 10021034 1/Prevax 21MAY2020 1 10.00 10.00 BLQ BLQ
1/1 Week 28MAY2020 8 10.00 10.00 BLQ BLQ
1/3 Weeks 09JUN2020 20 34.06 10.00 1467.192 2472.885
1/4 Weeks 16JUN2020 27
1299.986 1661.698
090177e194ffe59c\Final\Final On: 24-Sep-2020 03:39 (GMT)
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16.2.6.1.1.1 Listing of Assay Data Before Dose 2 – Phase 1 – BNT162b1 (100 μg )
Assay
Vaccine
Candidate Age Group
(Years) Vaccine Group
(as Randomized) Subject Dose/
Sampling
Time Point Date of
Sample Rel
Daya NT50
(Titer) NT90
(Titer) S1-Binding
IgG Level
(U/mL) RBD -Binding
IgG Level
(U/mL)
1/5 Weeks 23JUN2020 34 10.00 10.00 1015.168 1784.978
1/7 Weeks 09JUL2020 50 10.00 10.00 976.009 1172.711
C4591001 1002 10021035 1/Prevax 21MAY2020 1 10.00 10.00 BLQ BLQ
1/1 Week 28MAY2020 8 10.00 10.00 BLQ BLQ
1/3 Weeks 09JUN2020 20 10.00 10.00 790.157 1303.880
1/4 Weeks 16JUN2020 27
497.281 751.609
1/5 Weeks 23JUN2020 34 10.00 10.00 398.655 528.401
1/7 Weeks 07JUL2020 48 10.00 10.00 323.372 417.140
C4591001 1002 10021036 1/Prevax 21MAY2020 1 10.00 10.00 7.661 6.568
1/1 Week 28MAY2020 8 10.00 10.00 37.869 29.364
1/3 Weeks 11JUN2020 22 10.00 10.00 886.004 1438.446
1/4 Weeks 17JUN2020 28
570.488 672.895
1/5 Weeks 23JUN2020 34 10.00 10.00 560.702 589.342
1/7 Weeks 16JUL2020 57 10.00 10.00 510.114 440.135
C4591001 1002 10021038 1/Prevax 21MAY2020 1 10.00 10.00 BLQ BLQ
1/1 Week 28MAY2020 8 10.00 10.00 BLQ BLQ
1/3 Weeks 09JUN2020 20 10.00 10.00 294.603 472.124
1/4 Weeks 16JUN2020 27
321.612 389.529
1/5 Weeks 23JUN2020 34 10.00 10.00 406.950 487.004
1/7 Weeks 09JUL2020 50 10.00 10.00 351.319 443.855
Placebo 18-55 Placebo C4591001 1001 10011013 1/Prevax 18MAY2020 1 10.00 10.00 BLQ BLQ
1/1 Week 26MAY2020 9 10.00 10.00 BLQ BLQ
1/3 Weeks 08JUN2020 22 10.00 10.00 BLQ BLQ
1/4 Weeks 16JUN2020 30
BLQ BLQ
1/5 Weeks 23JUN2020 37 10.00 10.00 BLQ BLQ
1/7 Weeks 07JUL2020 51 10.00 10.00 BLQ BLQ
090177e194ffe59c\Final\Final On: 24-Sep-2020 03:39 (GMT)
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16.2.6.1.1.1 Listing of Assay Data Before Dose 2 – Phase 1 – BNT162b1 (100 μg )
Assay
Vaccine
Candidate Age Group
(Years) Vaccine Group
(as Randomized) Subject Dose/
Sampling
Time Point Date of
Sample Rel
Daya NT50
(Titer) NT90
(Titer) S1-Binding
IgG Level
(U/mL) RBD -Binding
IgG Level
(U/mL)
C4591001 1001 10011021 1/Prevax 20MAY2020 1 10.00 10.00 BLQ BLQ
1/1 Week 28MAY2020 9 10.00 10.00 BLQ 1.519
1/3 Weeks 10JUN2020 22 10.00 10.00 BLQ 1.960
1/4 Weeks 17JUN2020 29
BLQ 1.679
1/5 Weeks 23JUN2020 35 10.00 10.00 BLQ BLQ
1/7 Weeks 09JUL2020 51 10.00 10.00 BLQ BLQ
C4591001 1002 10021041 1/Prevax 21MAY2020 1 10.00 10.00 BLQ BLQ
1/1 Week 28MAY2020 8 10.00 10.00 BLQ BLQ
1/3 Weeks 09JUN2020 20 10.00 10.00 BLQ BLQ
1/4 Weeks 16JUN2020 27
BLQ BLQ
1/5 Weeks 23JUN2020 34 10.00 10.00 BLQ BLQ
1/7 Weeks 09JUL2020 50 10.00 10.00 BLQ BLQ
Abbreviations: IgG = immunoglobulin G; BLQ = below the limit of quantitation; NT50 = 50% neutralizing titer; NT90 = 90% neutr alizing titer;
RBD = receptor -binding domain; S1 = spike protein S1 subunit.
a. Relative Day (Rel Day) = date of blood draw - date of last vaccination + 1.
PFIZER CONFIDENTIAL SDTM Creation: 17SEP2020 (22:01) Source Data: adva Table Generation: 21SEP2020 (21:56)
(Cutoff Date: 24AUG2020, Snapshot Date: 17SEP2020) Output File: ./nda3/C4591001 IA P1 100/adva l001 100 p1
090177e194ffe59c\Final\Final On: 24-Sep-2020 03:39 (GMT)
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