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Summary of Geometric Mean Titers, by Baseline SARS -CoV-2 Status – NT50 – Subjects 12 Through 15 a nd 16 Through 25 Years of Age (Immunogenicity
Subset) – D ose 2 Eval uable Immunog enicity Population ............................................................................................................................................................................. 2
Summary of Geometric Mean Titers, by Baseline SARS -CoV-2 Status – NT50 – Subjects 12 Through 15 and 16 Through 25 Years of Age (Immunogenicity
Subset) – D ose 2 All -Ava ilable Immunogenicity Population ....................................................................................................................................................................... 4
Summary of Geometric Mean Fold Rise From Before Va ccination to Each Subsequent Time Point, by Baseline SARS -CoV-2 Status – NT50 – Subjects 12
Thr oug h 15 and 16 Through 25 Years of Age ( Immunog enicity S ubset) – D ose 2 Eval uable Immunogenicity P opul ation .................................................................. 6
Summary of Geometric Mean Fold Rise From Before Vaccination to Each Subsequent Time Point, by Baseline SARS -CoV-2 Status – NT50 – Subjects 12
Thr oug h 15 and 16 Through 25 Years of Age ( Immunog enicity S ubset) – D ose 2 All -Ava ilable Immunogenicity Population ............................................................ 7
Summary of Geometric Mean Ratio – NT50 – Comparison of Subjects 12 Through 15 Years of Age to Subjects 16 Through 25 Years of Age (Immunogenicity
Subset) – S ubjects Without Evidence of Infection up to 1 Month A fter D ose 2 – Dose 2 Eva luable Immunogenicity Popula tion ....................................................... 8
Number (%) of Subjects Achieving a ≥4 -Fold Rise From Before Vaccination to Each Subsequent Time Point, by Baseline SARS -CoV-2 Status – NT50 –
Subjects 12 Thr oug h 15 and 16 Thr ough 25 Years of Age (Immunogenicity S ubset) – D ose 2 Evaluabl e Immunogenicity P opul ation .............................................. 9
Number (%) of Subjects A ch ievin g a ≥4 -Fold Rise From Before Vaccination to Each Subsequent Time Point 1 Month After Dose 2 – NT50 – Comparison of
Subjects 12 Through 15 Years of Age to Subjects 16 Through 25 Years of Age (Immunogenicity Subset) – Subjects Without Evidence of Infe ction up to 1
Month After D ose 2 – Dose 2 Eval uable Immunogenicity Popul ati on ......................................................................................................................................................10
Listing of Assay Data – S ubjects 12 Thr oug h 25 Y ears of Age ................................................................................................................................................................. 11
Reverse Cumulative Distribution Curves, SARS -CoV-2 Neutralization Assa y – NT50 – Subjects 12 Through 15 and 16 Through 25 Years of Age
(Immunog enicity S ubset) – D ose 2 Eval uable Immunog enicity P opul ation .............................................................................................................................................50
Geometric Mean Titers and 95% CIs: SARS -CoV-2 Neutralization Assay – NT50 – Subjects 12 Through 15 and 16 Through 25 Years of Age (Immunogenicity
Subset) – D ose 2 Eval uable Immunog enicity P opul ation ...........................................................................................................................................................................51
090177e1998dbeb3\Final\Final On: 08-Mar-2022 12:27 (GMT)
FDA-CBER-2022-5812-0235543
Summary of Geometric Mean T iters, by Baseline SARS -CoV -2 Status – NT50 –
Subjects 12 Through 15 and 16 Through 25 Years of Age (Immunogenicity Subset) –
Dose 2 Evaluable Immunogenicity Population
Vaccine Group (as Randomized)
BNT162b2 (30 μg)
Placebo
12-15 Years 16-25 Years 12-15 Years 16-25 Years
Assay Dose/
Sampling
Time Pointa Baseline
SARS -CoV-2
Statusb nc GMTd
(95% CId) nc GMTd
(95% CId) nc GMTd
(95% CId) nc GMTd
(95% CId)
SARS -CoV -2 neutralization
assay - NT50 (titer) 1/Prevax ALL 155 22.2
(20.7, 23.8) 136 21.1
(20.2, 22.0) 29 22.3
(18.7, 26.7) 24 20.5
(20.5, 20.5)
POS 8 61.0
(26.4, 140.8) 5 45.3
(10.2, 201.9) 1 251.0
(NE, NE) 0 NE
(NE, NE)
NEG 146 21.0
(20.0, 22.1) 131 20.5
(20.5, 20.5) 27 20.5
(20.5, 20.5) 24 20.5
(20.5, 20.5)
2/1 Month ALL 207 1296.4
(1160.4, 1448.4) 185 733.6
(651.0, 826.8) 36 27.3
(20.9, 35.6) 32 21.5
(19.5, 23.7)
POS 10 2342.2
(1308.7, 4191.8) 8 1439.2
(727.1, 2848.7) 2 191.0
(1.2, 30873.6) 1 20.5
(NE, NE)
NEG 192 1253.2
(1118.6, 1404.1) 177 711.6
(630.7, 802.9) 33 24.4
(19.4, 30.8) 31 21.5
(19.5, 23.8)
Abbrevia tions: COVID -19 = coronavirus disease 2019; GMT = geometric mean titer; LLOQ = lower limit of quantitation;
NAAT = nucleic a cid amplification test; N-binding = SARS -CoV -2 nucleoprotein –binding; NE = not estimable; NEG = nega tive;
NT50 = 50% neutralizing titer; POS = positive; Prevax = before vaccination; SARS -CoV-2 = severe acute respiratory syndrome coronavirus 2.
a. Protocol -specified timing for blood sample collection.
b. POS = positive N -binding antibody result at Visit 1, positive NAAT result at Visit 1, or medical history of COVID -19. NEG = negative N -binding
antibody result at Visit 1, negative NAAT result at Visit 1, and no medical hist ory of COVID- 19. ALL = irrespective of baseline SARS -CoV-2 status, including
missing ba seline status.
c. n = Number of subjects with valid and determinate assay results for the specified assay at the given dose/sampling time point .
d. GMTs and 2 -sided 95% CIs were ca lculated by exponentiating the mean loga rithm of the titers a nd the corresponding CIs (based on the Studen t t
090177e1998dbeb3\Final\Final On: 08-Mar-2022 12:27 (GMT)
FDA-CBER-2022-5812-0235544
Summary of Geometric Mean T iters, by Baseline SARS -CoV -2 Status – NT50 –
Subjects 12 Through 15 and 16 Through 25 Years of Age (Immunogenicity Subset) –
Dose 2 Evaluable Immunogenicity Population
Vaccine Group (as Randomized)
BNT162b2 (30 μg)
Placebo
12-15 Years 16-25 Years 12-15 Years 16-25 Years
Assay Dose/
Sampling
Time Pointa Baseline
SARS -CoV-2
Statusb nc GMTd
(95% CId) nc GMTd
(95% CId) nc GMTd
(95% CId) nc GMTd
(95% CId)
distribution). Assay results below the LLOQ were set to 0.5 × LLOQ.
PFIZER CONFIDENTIAL SDTM Creation: 09FEB2022 (12:16) Source Da ta: adva Table Generation: 09FEB2022 (18:59)
(Cutoff Date: 13MAR2021, Snapshot Da te: 25MAR2021) Output File: ./nda3_unblinded/C4591001_BLA_IMM/adva_s001_gm_ped_eval
090177e1998dbeb3\Final\Final On: 08-Mar-2022 12:27 (GMT)
FDA-CBER-2022-5812-0235545
Summary of Geometric Mean Titers, by Baseline SARS -CoV -2 Status – NT50 –
Subjects 12 Through 15 and 16 Through 25 Years of Age (Immunogenicity Subset) –
Dose 2 All -Available Immunogenicity Population
Vaccine Group (as Randomized)
BNT162b2 (30 μg)
Placebo
12-15 Years 16-25 Years 12-15 Years 16-25 Years
Assay Dose/
Sampling
Time Pointa Baseline
SARS -CoV-2
Statusb nc GMTd
(95% CId) nc GMTd
(95% CId) nc GMTd
(95% CId) nc GMTd
(95% CId)
SARS -CoV -2 neutralization
assay - NT50 (titer) 1/Prevax ALL 156 22.2
(20.7, 23.8) 140 21.1
(20.2, 22.0) 29 22.3
(18.7, 26.7) 25 20.5
(20.5, 20.5)
POS 8 61.0
(26.4, 140.8) 5 45.3
(10.2, 201.9) 1 251.0
(NE, NE) 0 NE
(NE, NE)
NEG 147 21.0
(20.0, 22.1) 135 20.5
(20.5, 20.5) 27 20.5
(20.5, 20.5) 25 20.5
(20.5, 20.5)
2/1 Month ALL 208 1297.7
(1162.2, 1449.1) 190 729.0
(648.0, 820.1) 36 27.3
(20.9, 35.6) 34 21.4
(19.6, 23.5)
POS 10 2342.2
(1308.7, 4191.8) 8 1439.2
(727.1, 2848.7) 2 191.0
(1.2, 30873.6) 1 20.5
(NE, NE)
NEG 193 1254.8
(1120.6, 1405.1) 182 707.5
(628.2, 796.8) 33 24.4
(19.4, 30.8) 33 21.5
(19.5, 23.6)
Abbrevia tions: COVID -19 = coronavirus disease 2019; GMT = geometric mean titer; LLOQ = lower limit of quantitation;
NAAT = nucleic a cid amplification test; N -binding = SARS -CoV -2 nucleoprotein –binding; NE = not estimable; NEG = negative;
NT50 = 50% neutralizing titer; POS = positive; Prevax = before vaccination; SARS -CoV-2 = severe acute respiratory syndrome coronavirus 2.
a. Protocol -specified timing for blood sample collection.
b. POS = positive N -binding antibody result at Visit 1, positive NAAT result at Visit 1, or medical history of COVID -19. NEG = negative N -binding
antibody result at Visit 1, negative NAAT result at Visit 1, and no medical history of COVID -19. ALL = irrespective of baseline SARS -CoV-2 status, inclu ding
missing ba seline status.
c. n = Number of subjects with valid and determinate assay results for the specified assay at the given dose/sampling time point .
d. GMTs and 2 -sided 95% CIs were ca lculated by exponentiating the mean loga rithm of the titers a nd the corresponding CIs (based on the Student t
090177e1998dbeb3\Final\Final On: 08-Mar-2022 12:27 (GMT)
FDA-CBER-2022-5812-0235546
Summary of Geometric Mean Titers, by Baseline SARS -CoV -2 Status – NT50 –
Subjects 12 Through 15 and 16 Through 25 Years of Age (Immunogenicity Subset) –
Dose 2 All -Available Immunogenicity Population
Vaccine Group (as Randomized)
BNT162b2 (30 μg)
Placebo
12-15 Years 16-25 Years 12-15 Years 16-25 Years
Assay Dose/
Sampling
Time Pointa Baseline
SARS -CoV-2
Statusb nc GMTd
(95% CId) nc GMTd
(95% CId) nc GMTd
(95% CId) nc GMTd
(95% CId)
distribution). Assay results below the LLOQ were set to 0.5 × LLOQ.
PFIZER CONFIDENTIAL SDTM Creation: 09FEB2022 (12:16) Source Da ta: adva Table Generation: 09FEB2022 (18:59)
(Cutoff Date: 13MAR2021 , Snapshot Da te: 25MAR2021) Output File: ./nda3_unblinded/C4591001_BLA_IMM/adva_s001_gm_ped_aai
090177e1998dbeb3\Final\Final On: 08-Mar-2022 12:27 (GMT)
FDA-CBER-2022-5812-0235547
Summary of Geometric Mean Fold Rise From Before Vaccination to Each Subsequent Time Point, by Baseline
SARS -CoV-2 Status – NT5 0 – Subjects 12 Through 15 and 16 Through 25 Years of Age (Immunogenicity Subset) –
Dose 2 Evaluable Immunogenicity Population
Vaccine Group (as Randomized)
BNT162b2 (30 μg)
Placebo
12-15 Years 16-25 Years 12-15 Years 16-25 Years
Assay Dose/
Sampling
Time Pointa Baseline
SARS -CoV-2
Statusb nc GMFRd
(95% CId) nc GMFRd
(95% CId) nc GMFRd
(95% CId) nc GMFRd
(95% CId)
SARS -CoV -2 neutralization a ssay -
NT50 (titer) 2/1 Month ALL 154 60.4
(52.5, 69.4) 135 35.5
(30.6, 41.0) 29 1.2
(0.9, 1.6) 24 1.1
(0.9, 1.2)
POS 8 42.2
(24.8, 72.0) 5 40.2
(3.7, 437.7) 1 1.1
(NE, NE) 0 NE
(NE, NE)
NEG 145 61.9
(53.6, 71.5) 130 35.3
(30.7, 40.6) 27 1.2
(0.9, 1.6) 24 1.1
(0.9, 1.2)
Abbrevia tions: COVID -19 = coronavirus disease 2019; GMFR = geometric mean fold rise; LLOQ = lower limit of quantitation;
NAAT = nucleic a cid amplification test; N -binding = SARS -CoV -2 nucleoprotein –binding; NE = not estimable; NEG = nega tive;
NT50 = 50% neutralizing titer; POS = po sitive; SARS -CoV-2 = severe acute respiratory syndrome coronavirus 2.
a. Protocol -specified timing for blood sample collection.
b. POS = positive N -binding antibody result at Visit 1, positive NAAT result at Visit 1, or medical history of COVID -19. NEG = negative N- binding
antibody result at Visit 1, negative NAAT result at Visit 1, and no medical history of COVID -19. ALL = irrespective of baseline SARS -CoV-2 status, including
missing ba seline status.
c. n = Number of subjects with valid and det erminate assay results for the specified assay both prevaccination time points and at the given dose/sampling
time point.
d. GMFRs a nd 2 -sided 95% CIs were ca lculated by exponentiating the mean logarithm of fold rises a nd the corresponding CIs (based o n the Student t
distribution). Assay results below the LLOQ were set to 0.5 × LLOQ in the analysis.
PFIZER CONFIDENTIAL SDTM Creation: 09FEB2022 (12:16) Source Da ta: adva Table Generation: 09FEB2022 (18:59)
(Cutoff Date: 13MAR2021, Snapshot Date: 25MAR202 1) Output File: ./nda3_unblinded/C4591001_BLA_IMM/adva_s002_gmfr_ped_eval
090177e1998dbeb3\Final\Final On: 08-Mar-2022 12:27 (GMT)
FDA-CBER-2022-5812-0235548
Summary of Geometric Mean Fold Rise From Before Vaccination to Each Subsequent Time Point, by Baseline
SARS -CoV-2 Status – NT50 – Subjects 12 Through 15 and 16 Through 25 Years of Age (Immunogenicity Subset) –
Dose 2 All -Available Immunogenicity Population
Vaccine Group (as Randomized)
BNT162b2 (30 μg)
Placebo
12-15 Years 16-25 Years 12-15 Years 16-25 Years
Assay Dose/
Sampling
Time Pointa Baseline
SARS -CoV-2
Statusb nc GMFRd
(95% CId) nc GMFRd
(95% CId) nc GMFRd
(95% CId) nc GMFRd
(95% CId)
SARS -CoV -2 neutralization a ssay -
NT50 (titer) 2/1 Month ALL 155 60.5
(52.7, 69.4) 139 35.0
(30.3, 40.4) 29 1.2
(0.9, 1.6) 25 1.1
(0.9, 1.2)
POS 8 42.2
(24.8, 72.0) 5 40.2
(3.7, 437.7) 1 1.1
(NE, NE) 0 NE
(NE, NE)
NEG 146 62.0
(53.7, 71.6) 134 34.8
(30.4, 40.0) 27 1.2
(0.9, 1.6) 25 1.1
(0.9, 1.2)
Abbrevia tions: COVID -19 = coronavirus disease 2019; GMFR = geometric mean fold rise; LLOQ = lower limit of quantitation;
NAAT = nucleic a cid amplification test; N -binding = SARS -CoV -2 nucleoprotein –binding; NE = not estimable; NEG = nega tive;
NT50 = 50% neutralizing titer; POS = positive; SARS -CoV-2 = sever e acute respiratory syndrome coronavirus 2.
a. Protocol -specified timing for blood sample collection.
b. POS = positive N -binding antibody result at Visit 1, positive NAAT result at Visit 1, or medical history of COVID -19. NEG = negative N -binding
antibody result at Visit 1, negative NAAT result at Visit 1, and no medical history of COVID -19. ALL = irrespective of baseline SARS -CoV-2 status, including
missing ba seline status.
c. n = Number of subjects with valid and determinate assay results for the specified assay both prevaccination time points a nd a t the given dose/sampling
time point.
d. GMFRs a nd 2 -sided 95% CIs were ca lculated by exponentiating the mean logarithm of fold rises a nd the corresponding CIs (based on the Student t
distributi on). Assay results below the LLOQ were set to 0.5 × LLOQ in the analysis.
PFIZER CONFIDENTIAL SDTM Creation: 09FEB2022 (12:16) Source Da ta: adva Table Generation: 09FEB2022 (18:59)
(Cutoff Date: 13MAR2021, Snapshot Da te: 25MAR2021) Output File: ./nda3_unb linded/C4591001_BLA_IMM/adva_s002_gmfr_ped_aai
090177e1998dbeb3\Final\Final On: 08-Mar-2022 12:27 (GMT)
FDA-CBER-2022-5812-0235549
Summary of Geometric Mean Ratio – NT50 –
Comparison of Subjects 12 Through 15 Years of Age to Subjects 16 Through 25 Years of Age (Immunogenicity Subset) –
Subjects Without Evidence of Infection up to 1 Month After Dose 2 – Dose 2 Evaluable Immunogenicity Population
Vaccine Group (as Randomized)
BNT162b2 (30 μg)
12-15 Years 16-25 Years 12-15 Years/16 -25 Years
Assay Dose/
Sampling
Time Pointa nb GMTc
(95% CIc) nb GMTc
(95% CIc) GMRd
(95% CId) Met Noninferiority
Objectivee
(Y/N)
SARS -CoV -2 neutralization a ssay -
NT50 (titer) 2/1 Month 190 1253.6
(1117.7, 1406.1) 170 708.1
(625.9, 801.1) 1.77
(1.50, 2.09) Y
Abbrevia tions: GMR = geometric mean ra tio; GMT = geometric mean titer; LLOQ = lower limit of qua ntitation;
NT50 = 50% neutralizing titer; SARS -CoV-2 = severe acute respiratory syndrome coronavirus 2.
Note: Subjects who had no serological or virological evi dence (up to 1 month after receipt of the last dose) of past SARS -CoV-2 infection (ie, N -binding
antibody [serum] neg ative at Visit 1 and SARS -CoV-2 not detected by NAAT [nasal swab] at Visits 1 and 2), and had negative NAAT (nasal swab) at any
unscheduled visit up to 1 month after Dose 2 were included in the analysis.
a. Protocol -specified timing for blood sample collection.
b. n = Number of subjects with valid and determinate assay results for the specified assay at the given dose/sampling time po int.
c. GMTs and 2 -sided 95% CIs were calculated by exponentiating the mean logarithm of the titers a nd the corresponding CIs (based on the Stud ent t
distribution). Assay results below the LLOQ were set to 0.5 × LLOQ.
d. GMRs and 2 -sided 95% CIs we re calculated by exponentiating the mean difference of the logarithms of the titers (Group 1 [12 -15 years] – Group 2 [16 -25
years]) and the corresponding CI (based on the Student t distribution).
e. Noninferiority is declared if the lower bound of the 2-sided 95% CI for the GMR is greater than 0.67.
PFIZER CONFIDENTIAL SDTM Creation: 09FEB2022 (12:16) Source Da ta: adva Table Generation: 09FEB2022 (18:59)
(Cutoff Date: 13MAR2021, Snapshot Da te: 25MAR2021) Output File: ./nda3_unblinded/C4591001_BLA_IMM/a dva_s001_gmr_ped_ev_eval
090177e1998dbeb3\Final\Final On: 08-Mar-2022 12:27 (GMT)
FDA-CBER-2022-5812-0235550
Number (%) of Subjects Achieving a ≥4 -Fold Rise From Before Vaccination to Each Subsequent Time Point,
by Baseline SARS-CoV-2 Status – NT50 – Subjects 12 Through 15 and 16 Through 25 Year s of Age
(Immunogenicity Subset) – Dose 2 Evaluable Immunogenicity Population
Vaccine Group (as Randomized)
BNT162b2 (30 μg)
Placebo
12-15 Years 16-25 Years 12-15 Years 16-25 Years
Assay Dose/
Sampling
Time Pointa Baseline
SARS -CoV-2
Statusb Nc nd (%)
(95% CIe) Nc nd (%)
(95% CIe) Nc nd (%)
(95% CIe) Nc nd (%)
(95% CIe)
SARS -CoV -2 neutralization a ssay -
NT50 (titer) 2/1 Month ALL 154 150 (97.4)
(93.5, 99.3) 135 130 (96.3)
(91.6, 98.8) 29 1 (3.4)
(0.1, 17.8) 24 0 (0.0)
(0.0, 14.2)
POS 8 8 (100.0)
(63.1, 100.0) 5 4 (80.0)
(28.4, 99.5) 1 0 (0.0)
(0.0, 97.5) 0 0 (NE)
(NE, NE)
NEG 145 141 (97.2)
(93.1, 99.2) 130 126 (96.9)
(92.3, 99.2) 27 1 (3.7)
(0.1, 19.0) 24 0 (0.0)
(0.0, 14.2)
Abbrevia tions: LLOQ = lower limit of qua ntitation; NE = not estimable; NT50 = 50% neutralizing titer; SARS -CoV-2 = severe acute respiratory syndrome
coronavirus 2.
Note: Baseline assay results below the LLOQ were set to LLOQ in the analysis.
a. Protoco l-specified timing for blood sample collection.
b. POS = positive N -binding antibody result at Visit 1, positive NAAT result at Visit 1, or medical history of COVID -19. NEG = negative N -binding
a ntibody result at Visit 1, nega tive NAAT result a t Visit 1, and no medical history of COVID -19. ALL = irrespective of baseline SARS -CoV-2 status, including
missing ba seline status
c. N = number of subjects with valid and determinate assay results for the specified assay both before vaccination and at the gi ven dose/sampling time point.
These values are the denominators for the percentage calculations.
d. n = Number of subjects with ≥4 -fold rise from before vaccination for the given assay at the given dose/sampling time point.
e. Exact 2 -sided CI based on the Clopper a nd Pearson method.
PFIZER CONFIDENTIAL SDTM Creation: 09FEB2022 (12:16) Source Da ta: adva Table Generation: 09FEB2022 (18:59)
(Cutoff Date: 13MAR2021, Snapshot Da te: 25MAR2021) Output File: ./nda3_unblinded/C4591001_BLA_IMM/adva_s001_4fol d_ped_eval
090177e1998dbeb3\Final\Final On: 08-Mar-2022 12:27 (GMT)
FDA-CBER-2022-5812-0235551
Number (%) of Subjects Achieving a ≥4 -Fold Rise From Before Vaccination to Each Subsequent Time Point
1 Month After Dose 2 – NT50 – Comparison of Subjects 12 Through 15 Years of Age to Subjects 16 Through 25
Years of Age (Immunogenicity Subset) – Subjects Without Evidence of Infection up to 1 Month After Dose 2 –
Dose 2 Evaluable Immunogenicity Population
Vaccine Group (as Randomized)
BNT162b2 (30 μg)
12-15 Years 16-25 Years Difference
Assay Dose/
Sampling
Time Pointa Nb nc (%)
(95% CId) Nb nc (%)
(95% CId) %e (95% CIf)
SARS -CoV -2 neutralization a ssay - NT50 (titer) 2/1 Month 143 139 (97.2)
(93.0, 99.2) 124 120 (96.8)
(91.9, 99.1) 0.4 (-4.2, 5.5)
Abbrevia tions: LLOQ = lower limit of qua ntitation; NT50 = 50% neutralizing titer; SARS -CoV-2 = severe a cute respira tory syndrome coronavirus 2.
Note: Subjects who had no serological or virological evidence (up to 1 month after receipt of the last dose) of past SARS -CoV-2 infection (ie, N -binding
antibody [serum] neg ative at Visit 1 and SARS -CoV-2 not detected by NAAT [nasal swab] at Visits 1 and 2), and had negative NAAT ( nas al swab ) at any
unscheduled visit up to 1 month after Dose 2 were included in the analysis.
Note: Baseline assay results below the LLOQ were set to LLOQ in the analysis.
a. Protocol -specified timing for blood sample collection.
b. N = number of subjects with valid and determinate assay results for the specified assay both before vaccination and at the given dose/sampl ing time point.
These values are the denominators for the percentage calculations.
c. n = Number of subjects with ≥4 -fold rise from before vaccination for the given assay at the given dose/sampling time point.
d. Exa ct 2 -sided CI based on the Clopper a nd Pearson method.
e. Difference in proportions, expressed as a percentage (12 -15 years – 16-25 years).
f. 2- Sided CI, based on the Miettinen and Nurminen method for the difference in proportions, expressed as a percentage.
PFIZER CONFIDENTIAL SDTM Creation: 09FEB2022 (12:16) Source Da ta: adva Table Generation: 09FEB2022 (18:59)
(Cutoff Date: 13MAR2021, Snapshot Date: 25M AR2021) Output File: ./nda3_unblinded/C4591001_BLA_IMM/adva_s003_4fold_ped_eval
090177e1998dbeb3\Final\Final On: 08-Mar-2022 12:27 (GMT)
FDA-CBER-2022-5812-0235552
16.2.6.1 Listing of Assay Data – Subjects 12 Through 25 Years of Age
Age Group (Years) Vaccine Group
(as Randomized) Subject Dose/
Sampling
Time Point Date of
Sample Rel
Daya NT50
(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
090177e1998dbeb3\Final\Final On: 08-Mar-2022 12:27 (GMT)
FDA-CBER-2022-5812-0235553
16.2.6.1 Listing of Assay Data – Subjects 12 Through 25 Years of Age
Age Group (Years) Vaccine Group
(as Randomized) Subject Dose/
Sampling
Time Point Date of
Sample Rel
Daya NT50
(Titer)
2/1 Month 10DEC2020 29 1629
C4591001 1007 10071467 1/Prevax 30NOV2020 1 10
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
090177e1998dbeb3\Final\Final On: 08-Mar-2022 12:27 (GMT)
FDA-CBER-2022-5812-0235554
16.2.6.1 Listing of Assay Data – Subjects 12 Through 25 Years of Age
Age Group (Years) Vaccine Group
(as Randomized) Subject Dose/
Sampling
Time Point Date of
Sample Rel
Daya NT50
(Titer)
C4591001 1007 10071537 1/Prevax 09DEC2020 1 10
2/1 Month 27JAN2021 29 1326
C4591001 1007 10071546 1/Prevax 10DEC2020 1 10
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
090177e1998dbeb3\Final\Final On: 08-Mar-2022 12:27 (GMT)
FDA-CBER-2022-5812-0235555
16.2.6.1 Listing of Assay Data – Subjects 12 Through 25 Years of Age
Age Group (Years) Vaccine Group
(as Randomized) Subject Dose/
Sampling
Time Point Date of
Sample Rel
Daya NT50
(Titer)
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
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
090177e1998dbeb3\Final\Final On: 08-Mar-2022 12:27 (GMT)
FDA-CBER-2022-5812-0235556
16.2.6.1 Listing of Assay Data – Subjects 12 Through 25 Years of Age
Age Group (Years) Vaccine Group
(as Randomized) Subject Dose/
Sampling
Time Point Date of
Sample Rel
Daya NT50
(Titer)
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
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
090177e1998dbeb3\Final\Final On: 08-Mar-2022 12:27 (GMT)
FDA-CBER-2022-5812-0235557
16.2.6.1 Listing of Assay Data – Subjects 12 Through 25 Years of Age
Age Group (Years) Vaccine Group
(as Randomized) Subject Dose/
Sampling
Time Point Date of
Sample Rel
Daya NT50
(Titer)
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
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
090177e1998dbeb3\Final\Final On: 08-Mar-2022 12:27 (GMT)
FDA-CBER-2022-5812-0235558
16.2.6.1 Listing of Assay Data – Subjects 12 Through 25 Years of Age
Age Group (Years) Vaccine Group
(as Randomized) Subject Dose/
Sampling
Time Point Date of
Sample Rel
Daya NT50
(Titer)
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
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
090177e1998dbeb3\Final\Final On: 08-Mar-2022 12:27 (GMT)
FDA-CBER-2022-5812-0235559
16.2.6.1 Listing of Assay Data – Subjects 12 Through 25 Years of Age
Age Group (Years) Vaccine Group
(as Randomized) Subject Dose/
Sampling
Time Point Date of
Sample Rel
Daya NT50
(Titer)
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
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
090177e1998dbeb3\Final\Final On: 08-Mar-2022 12:27 (GMT)
FDA-CBER-2022-5812-0235560
16.2.6.1 Listing of Assay Data – Subjects 12 Through 25 Years of Age
Age Group (Years) Vaccine Group
(as Randomized) Subject Dose/
Sampling
Time Point Date of
Sample Rel
Daya NT50
(Titer)
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
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
090177e1998dbeb3\Final\Final On: 08-Mar-2022 12:27 (GMT)
FDA-CBER-2022-5812-0235561
16.2.6.1 Listing of Assay Data – Subjects 12 Through 25 Years of Age
Age Group (Years) Vaccine Group
(as Randomized) Subject Dose/
Sampling
Time Point Date of
Sample Rel
Daya NT50
(Titer)
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
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
090177e1998dbeb3\Final\Final On: 08-Mar-2022 12:27 (GMT)
FDA-CBER-2022-5812-0235562
16.2.6.1 Listing of Assay Data – Subjects 12 Through 25 Years of Age
Age Group (Years) Vaccine Group
(as Randomized) Subject Dose/
Sampling
Time Point Date of
Sample Rel
Daya NT50
(Titer)
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
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
090177e1998dbeb3\Final\Final On: 08-Mar-2022 12:27 (GMT)
FDA-CBER-2022-5812-0235563
16.2.6.1 Listing of Assay Data – Subjects 12 Through 25 Years of Age
Age Group (Years) Vaccine Group
(as Randomized) Subject Dose/
Sampling
Time Point Date of
Sample Rel
Daya NT50
(Titer)
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
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
090177e1998dbeb3\Final\Final On: 08-Mar-2022 12:27 (GMT)
FDA-CBER-2022-5812-0235564
16.2.6.1 Listing of Assay Data – Subjects 12 Through 25 Years of Age
Age Group (Years) Vaccine Group
(as Randomized) Subject Dose/
Sampling
Time Point Date of
Sample Rel
Daya NT50
(Titer)
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
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
090177e1998dbeb3\Final\Final On: 08-Mar-2022 12:27 (GMT)
FDA-CBER-2022-5812-0235565
16.2.6.1 Listing of Assay Data – Subjects 12 Through 25 Years of Age
Age Group (Years) Vaccine Group
(as Randomized) Subject Dose/
Sampling
Time Point Date of
Sample Rel
Daya NT50
(Titer)
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
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
090177e1998dbeb3\Final\Final On: 08-Mar-2022 12:27 (GMT)
FDA-CBER-2022-5812-0235566
16.2.6.1 Listing of Assay Data – Subjects 12 Through 25 Years of Age
Age Group (Years) Vaccine Group
(as Randomized) Subject Dose/
Sampling
Time Point Date of
Sample Rel
Daya NT50
(Titer)
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
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
090177e1998dbeb3\Final\Final On: 08-Mar-2022 12:27 (GMT)
FDA-CBER-2022-5812-0235567
16.2.6.1 Listing of Assay Data – Subjects 12 Through 25 Years of Age
Age Group (Years) Vaccine Group
(as Randomized) Subject Dose/
Sampling
Time Point Date of
Sample Rel
Daya NT50
(Titer)
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
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
090177e1998dbeb3\Final\Final On: 08-Mar-2022 12:27 (GMT)
FDA-CBER-2022-5812-0235568
16.2.6.1 Listing of Assay Data – Subjects 12 Through 25 Years of Age
Age Group (Years) Vaccine Group
(as Randomized) Subject Dose/
Sampling
Time Point Date of
Sample Rel
Daya NT50
(Titer)
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
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
090177e1998dbeb3\Final\Final On: 08-Mar-2022 12:27 (GMT)
FDA-CBER-2022-5812-0235569
16.2.6.1 Listing of Assay Data – Subjects 12 Through 25 Years of Age
Age Group (Years) Vaccine Group
(as Randomized) Subject Dose/
Sampling
Time Point Date of
Sample Rel
Daya NT50
(Titer)
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
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
090177e1998dbeb3\Final\Final On: 08-Mar-2022 12:27 (GMT)
FDA-CBER-2022-5812-0235570
16.2.6.1 Listing of Assay Data – Subjects 12 Through 25 Years of Age
Age Group (Years) Vaccine Group
(as Randomized) Subject Dose/
Sampling
Time Point Date of
Sample Rel
Daya NT50
(Titer)
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
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
090177e1998dbeb3\Final\Final On: 08-Mar-2022 12:27 (GMT)
FDA-CBER-2022-5812-0235571
16.2.6.1 Listing of Assay Data – Subjects 12 Through 25 Years of Age
Age Group (Years) Vaccine Group
(as Randomized) Subject Dose/
Sampling
Time Point Date of
Sample Rel
Daya NT50
(Titer)
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
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
090177e1998dbeb3\Final\Final On: 08-Mar-2022 12:27 (GMT)
FDA-CBER-2022-5812-0235572
16.2.6.1 Listing of Assay Data – Subjects 12 Through 25 Years of Age
Age Group (Years) Vaccine Group
(as Randomized) Subject Dose/
Sampling
Time Point Date of
Sample Rel
Daya NT50
(Titer)
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
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
090177e1998dbeb3\Final\Final On: 08-Mar-2022 12:27 (GMT)
FDA-CBER-2022-5812-0235573
16.2.6.1 Listing of Assay Data – Subjects 12 Through 25 Years of Age
Age Group (Years) Vaccine Group
(as Randomized) Subject Dose/
Sampling
Time Point Date of
Sample Rel
Daya NT50
(Titer)
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
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
090177e1998dbeb3\Final\Final On: 08-Mar-2022 12:27 (GMT)
FDA-CBER-2022-5812-0235574
16.2.6.1 Listing of Assay Data – Subjects 12 Through 25 Years of Age
Age Group (Years) Vaccine Group
(as Randomized) Subject Dose/
Sampling
Time Point Date of
Sample Rel
Daya NT50
(Titer)
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
C4591001 1054 10541007 1/Prevax 19AUG2020 1 10
2/1 Month 06OCT2020 29 658
C4591001 1054 10541090 1/Prevax 01SEP2020 1 10
090177e1998dbeb3\Final\Final On: 08-Mar-2022 12:27 (GMT)
FDA-CBER-2022-5812-0235575
16.2.6.1 Listing of Assay Data – Subjects 12 Through 25 Years of Age
Age Group (Years) Vaccine Group
(as Randomized) Subject Dose/
Sampling
Time Point Date of
Sample Rel
Daya NT50
(Titer)
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
2/1 Month 22SEP2020 29 240
C4591001 1082 10821036 2/1 Month 21SEP2020 28 1333
090177e1998dbeb3\Final\Final On: 08-Mar-2022 12:27 (GMT)
FDA-CBER-2022-5812-0235576
16.2.6.1 Listing of Assay Data – Subjects 12 Through 25 Years of Age
Age Group (Years) Vaccine Group
(as Randomized) Subject Dose/
Sampling
Time Point Date of
Sample Rel
Daya NT50
(Titer)
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
2/1 Month 13NOV2020 30 271
090177e1998dbeb3\Final\Final On: 08-Mar-2022 12:27 (GMT)
FDA-CBER-2022-5812-0235577
16.2.6.1 Listing of Assay Data – Subjects 12 Through 25 Years of Age
Age Group (Years) Vaccine Group
(as Randomized) Subject Dose/
Sampling
Time Point Date of
Sample Rel
Daya NT50
(Titer)
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
090177e1998dbeb3\Final\Final On: 08-Mar-2022 12:27 (GMT)
FDA-CBER-2022-5812-0235578
16.2.6.1 Listing of Assay Data – Subjects 12 Through 25 Years of Age
Age Group (Years) Vaccine Group
(as Randomized) Subject Dose/
Sampling
Time Point Date of
Sample Rel
Daya NT50
(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
090177e1998dbeb3\Final\Final On: 08-Mar-2022 12:27 (GMT)
FDA-CBER-2022-5812-0235579
16.2.6.1 Listing of Assay Data – Subjects 12 Through 25 Years of Age
Age Group (Years) Vaccine Group
(as Randomized) Subject Dose/
Sampling
Time Point Date of
Sample Rel
Daya NT50
(Titer)
C4591001 1116 11161256 1/Prevax 19SEP2020 1 10
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
090177e1998dbeb3\Final\Final On: 08-Mar-2022 12:27 (GMT)
FDA-CBER-2022-5812-0235580
16.2.6.1 Listing of Assay Data – Subjects 12 Through 25 Years of Age
Age Group (Years) Vaccine Group
(as Randomized) Subject Dose/
Sampling
Time Point Date of
Sample Rel
Daya NT50
(Titer)
2/1 Month 22JAN2021 33 2069
C4591001 1127 11271021 2/1 Month 15SEP2020 29 725
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
090177e1998dbeb3\Final\Final On: 08-Mar-2022 12:27 (GMT)
FDA-CBER-2022-5812-0235581
16.2.6.1 Listing of Assay Data – Subjects 12 Through 25 Years of Age
Age Group (Years) Vaccine Group
(as Randomized) Subject Dose/
Sampling
Time Point Date of
Sample Rel
Daya NT50
(Titer)
2/1 Month 14JAN2021 31 2154
C4591001 1140 11401006 1/Prevax 30JUL2020 1 10
2/1 Month 16SEP2020 29 627
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
090177e1998dbeb3\Final\Final On: 08-Mar-2022 12:27 (GMT)
FDA-CBER-2022-5812-0235582
16.2.6.1 Listing of Assay Data – Subjects 12 Through 25 Years of Age
Age Group (Years) Vaccine Group
(as Randomized) Subject Dose/
Sampling
Time Point Date of
Sample Rel
Daya NT50
(Titer)
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
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
090177e1998dbeb3\Final\Final On: 08-Mar-2022 12:27 (GMT)
FDA-CBER-2022-5812-0235583
16.2.6.1 Listing of Assay Data – Subjects 12 Through 25 Years of Age
Age Group (Years) Vaccine Group
(as Randomized) Subject Dose/
Sampling
Time Point Date of
Sample Rel
Daya NT50
(Titer)
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
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
090177e1998dbeb3\Final\Final On: 08-Mar-2022 12:27 (GMT)
FDA-CBER-2022-5812-0235584
16.2.6.1 Listing of Assay Data – Subjects 12 Through 25 Years of Age
Age Group (Years) Vaccine Group
(as Randomized) Subject Dose/
Sampling
Time Point Date of
Sample Rel
Daya NT50
(Titer)
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
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
090177e1998dbeb3\Final\Final On: 08-Mar-2022 12:27 (GMT)
FDA-CBER-2022-5812-0235585
16.2.6.1 Listing of Assay Data – Subjects 12 Through 25 Years of Age
Age Group (Years) Vaccine Group
(as Randomized) Subject Dose/
Sampling
Time Point Date of
Sample Rel
Daya NT50
(Titer)
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
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
090177e1998dbeb3\Final\Final On: 08-Mar-2022 12:27 (GMT)
FDA-CBER-2022-5812-0235586
16.2.6.1 Listing of Assay Data – Subjects 12 Through 25 Years of Age
Age Group (Years) Vaccine Group
(as Randomized) Subject Dose/
Sampling
Time Point Date of
Sample Rel
Daya NT50
(Titer)
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
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
090177e1998dbeb3\Final\Final On: 08-Mar-2022 12:27 (GMT)
FDA-CBER-2022-5812-0235587
16.2.6.1 Listing of Assay Data – Subjects 12 Through 25 Years of Age
Age Group (Years) Vaccine Group
(as Randomized) Subject Dose/
Sampling
Time Point Date of
Sample Rel
Daya NT50
(Titer)
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
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
090177e1998dbeb3\Final\Final On: 08-Mar-2022 12:27 (GMT)
FDA-CBER-2022-5812-0235588
16.2.6.1 Listing of Assay Data – Subjects 12 Through 25 Years of Age
Age Group (Years) Vaccine Group
(as Randomized) Subject Dose/
Sampling
Time Point Date of
Sample Rel
Daya NT50
(Titer)
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
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
090177e1998dbeb3\Final\Final On: 08-Mar-2022 12:27 (GMT)
FDA-CBER-2022-5812-0235589
16.2.6.1 Listing of Assay Data – Subjects 12 Through 25 Years of Age
Age Group (Years) Vaccine Group
(as Randomized) Subject Dose/
Sampling
Time Point Date of
Sample Rel
Daya NT50
(Titer)
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
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
090177e1998dbeb3\Final\Final On: 08-Mar-2022 12:27 (GMT)
FDA-CBER-2022-5812-0235590
16.2.6.1 Listing of Assay Data – Subjects 12 Through 25 Years of Age
Age Group (Years) Vaccine Group
(as Randomized) Subject Dose/
Sampling
Time Point Date of
Sample Rel
Daya NT50
(Titer)
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% neutr alizing titer.
a. Relative day (Rel Day) = date of blood draw - da te of la st vaccination + 1.
PFIZER CONFIDENTIAL SDTM Creation: 09FEB2022 (12:16) Source Da ta: adva Table Generation: 09FEB2022 (18:59)
(Cutoff Date: 13MAR2021, Snapshot Da te: 25MAR2021) Output File: ./nda3_unblinded/C4591001_BLA_IMM/adva_l001_ped
090177e1998dbeb3\Final\Final On: 08-Mar-2022 12:27 (GMT)
FDA-CBER-2022-5812-0235591
090177e1998dbeb3\Final\Final On: 08-Mar-2022 12:27 (GMT)
FDA-CBER-2022-5812-0235592
090177e1998dbeb3\Final\Final On: 08-Mar-2022 12:27 (GMT)
FDA-CBER-2022-5812-0235593