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

Objectives Estimands Endpoints
Secondary: Secondary: Secondary:
To describe the immune responses In participants complying with the key
elicited by prophylactic BNT162 protocol criteria (evaluable
vaccines in healthy adults after 1 or 2 participants) at the following time
doses points after receipt of study
intervention: 7 and 21 days after Dose
1; 7 and 14 days and 1, 6, 12, and 24
months after Dose 2
• Geometric mean titers (GMTs) at SARS-CoV-2 neutralizing titers
each time point
• Geometric mean fold rise (GMFR)
from before vaccination to each
subsequent time point after
vaccination
• Proportion of participants
achieving ≥4-fold rise from before
vaccination to each subsequent
time point after vaccination

• Geometric mean concentrations S1-binding IgG levels and RBD-
(GMCs) at each time point binding IgG levels
• GMFR from prior to first dose of
study intervention to each
subsequent time point
• Proportion of participants
achieving ≥4-fold rise from before
vaccination to each subsequent
time point after vaccination

• Geometric mean ratio (GMR), • SARS-CoV-2 neutralizing titers
estimated by the ratio of the
geometric mean of SARS-CoV-2 • S1-binding IgG levels
neutralizing titers to the geometric • RBD-binding IgG levels
mean of binding IgG levels at
each time point

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