Page 114 - pfizervax

PF-07302048 (BNT162 RNA-Based COVID-19 Vaccines)
Protocol C4591001

Endpoint Statistical Analysis Methods
participants with ≥4-fold rise will be provided for each investigational
product within each group at each of the following time points:

• Phase 1: 7 and 21 days after Dose 1; 7 and 14 days and 1, 6, 12,
and 24 months after Dose 2

The Clopper-Pearson method will be used to calculate the CIs.

GMR of SARS-CoV-2 neutralizing titer to S1-binding IgG level
and to RBD-binding IgG level

For SARS-CoV-2 neutralizing titers, S1-binding IgG levels, and
RBD-binding IgG levels, the GMRs and 2-sided 95% CIs will be
provided for each investigational product within each group at each of
the following time points:

• Phase 1: 7 and 21 days after Dose 1; 7 and 14 days and 1, 6, 12,
and 24 months after Dose 2

GMRs will be limited to participants with nonmissing values for both
SARS-CoV-2 neutralizing titers and S1-binding IgG level/RBD-
binding IgG level at each time point. The GMR will be calculated as
the mean of the difference of logarithmically transformed assay results
(eg, SARS-CoV-2 neutralizing titers minus S1-binding IgG level for
each participant) and exponentiating the mean. Two-sided CIs will be
obtained by calculating CIs using Student’s t-distribution for the mean
difference of the logarithmically transformed assay results and
exponentiating the confidence limits.

For all the immunogenicity endpoints, the analysis will be based on the
Dose 1 and Dose 2 evaluable immunogenicity populations. An
additional analysis will be performed based on the all-available
immunogenicity populations if there is a large enough difference in
sample size between the all-available immunogenicity populations and
the evaluable immunogenicity populations. Participants will be
summarized according to the vaccine group to which they were
randomized. Missing serology data will not be imputed.

Secondary GMR of SARS-CoV-2 neutralizing titers in participants 12 to 15
immunogenicity years of age to those 16 to 25 years of age
(noninferiority in
the 12- to 15-year For participants with no serological or virological evidence (up to
age group 1 month after receipt of the second dose) of past SARS-CoV-2
compared to the infection, the GMR of SARS-CoV-2 neutralizing titers in participants
12 to 15 years of age to those in participants 16 to 25 years of age and

Page 104