Trial Summary

Trial Summary Parameter
Planned Country of Investigational Sites

Parameter Value
2019 novel coronavirus vaccination (procedure)
To evaluate the immune response over time to prophylactic BNT162b2 and persistence of immune response in participants with and without serological
To evaluate the immune response (non-S) to SARS-CoV-2 in participants with and without confirmed COVID-19 during the study
To describe the serological responses to the BNT vaccine candidate in cases of: Confirmed COVID-19, Confirmed severe COVID-19, SARS-CoV-2 infection without confirmed COVID-19
To describe the safety and tolerability profiles of prophylactic BNT162 vaccines in healthy adults after 1 or 2 doses
To evaluate the efficacy of prophylactic BNT162b2 against confirmed COVID-19 in participants without evidence of infection before vaccination
To evaluate the efficacy of prophylactic BNT162b2 against confirmed COVID-19 in participants with and without evidence of infection before vaccination
To define the safety profile of prophylactic BNT162b2 in the first 360 participants randomized (Phase 2)
To define the safety profile of prophylactic BNT162b2 in all participants randomized in Phase 2/3
To describe the immune responses elicited by prophylactic BNT162 vaccines in healthy adults after 1 or 2 doses
To evaluate the efficacy of prophylactic BNT162b2 against confirmed severe COVID-19 in participants without evidence of infection before vaccination
To evaluate the efficacy of prophylactic BNT162b2 against confirmed severe COVID-19 in participants with and without evidence of infection before vaccination
To describe the efficacy of prophylactic BNT162b2 against confirmed COVID-19 (according to the CDC-defined symptoms) in participants without evidence of infection before vaccination
To describe the efficacy of prophylactic BNT162b2 against confirmed COVID-19 (according to the CDC-defined symptoms) in participants with and without evidence of infection before vaccination
GMT, GMFR, and percentage of participants with titers greater than defined threshold(s), at baseline and 1, 6, 12, and 24 months after completion of vaccination
GMTs/GMCs, GMFRs of SARS-CoV-2 serum neutralizing titers, SARS-CoV-2 anti-S1 binding antibody and anti-RBD binding antibody
Percentage of participants reporting local reactions (pain at the injection site, redness, and swelling) for up to 7 days following each dose
Percentage of participants reporting systemic events (fever, fatigue, headache, chills, vomiting, diarrhea, new or worsened muscle pain, and new or worsened joint pain)
Percentage of participants reporting adverse events from dose 1 to 1 month after the last dose
Percentage of participants reporting serious AEs (SAEs) from dose 1 to 6 months after the last dose
Percentage of participants with abnormal hematology and chemistry laboratory values 1 and 7 days after dose 1, and 7 days after dose 2
Percentage of participants with grading shifts in hematology and chemistry laboratory assessments between baseline and 1 and 7 days after dose 1, and before dose 2 and 7 days after dose 2
COVID-19 incidence per 1000 person-years of follow-up based on central laboratory or locally confirmed NAAT in participants with no serological
COVID-19 incidence per 1000 person-years of follow-up based on central laboratory or locally confirmed NAAT
Percentage of participants reporting local reactions (pain at the injection site, redness, and swelling) for up to 7 days following each dose in the first 360 participants randomized (Phase 2)
Percentage of participants reporting adverse events from dose 1 to 1 month after the last dose in the first 360 participants randomized (Phase 2)
Percentage of participants reporting serious AEs (SAEs) from dose 1 to 6 months after the last dose in the first 360 participants randomized (Phase 2)
Percentage of participants reporting adverse events from dose 1 to 1 month after the last dose in all participants randomized in Phase 2/3
Percentage of participants reporting serious AEs (SAEs) from dose 1 to 6 months after the last dose in all participants randomized in Phase 2/3
Percentage of participants reporting local reactions (pain at the injection site, redness, and swelling) for up to 7 days following each dose in a subset of at least 6000 participants
Geometric mean titers (GMTs) for SARS-CoV-2 serum neutralizing titers at each time point
Geometric mean fold rise (GMFR) in SARS-CoV-2 serum neutralizing titers 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 in SARS-CoV-2 serum neutralizing titers
Geometric mean concentrations (GMCs) for SARS-CoV-2 anti-S1 binding antibody levels and anti-RBD binding antibody levels at each time point
GMFR in SARS-CoV-2 anti-S1 binding antibody levels and anti-RBD binding antibody levels 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 in SARS-CoV-2 anti-S1 binding antibody levels
Geometric mean ratio (GMR), estimated by the ratio of the geometric mean of SARS-CoV-2 serum neutralizing titers to the geometric mean of SARS-CoV-2 binding antibody levels at each time point
Confirmed severe COVID-19 incidence per 1000 person-years of follow-up in participants with no serological or virological evidence of past SARS-CoV-2 infection
Confirmed severe COVID-19 incidence per 1000 person-years of follow-up
The sponsor designee reserves the right to close the study site or terminate the study at any time for any reason at the sole discretion of the sponsor.
A PHASE 1/2/3, PLACEBO-CONTROLLED, RANDOMIZED, OBSERVER-BLIND, DOSE-FINDING STUDY TO EVALUATE THE SAFETY, TOLERABILITY, IMMUNOGENICITY, AND EFFICACY

Parameter Value 1
or virological evidence of SARS-CoV-2 infection before vaccination
for SARS-CoV-2 anti-S1 binding antibody levels and/or anti-RBD binding antibody levels
for SARS-CoV-2 serum neutralizing titers
or virological evidence (up to 7 days after receipt of the last dose) of past SARS-CoV-2 infection
for up to 7 days following each dose in the first 360 participants randomized (Phase 2)
for up to 7 days following each dose in a subset of at least 6000 participants
OF SARS-COV-2 RNA VACCINE CANDIDATES AGAINST COVID-19 IN HEALTHY ADULTS