This is a Phase 1/2/3, randomized, placebo-controlled, observer-blind, dose-finding, vaccine candidate-selection, and efficacy study in healthy individuals.
The study consists of 2 parts: Phase 1: to identify preferred vaccine candidate(s) and dose level(s); Phase 2/3: an expanded cohort and efficacy part.
The study will evaluate the safety, tolerability, and immunogenicity of 2 different SARS CoV 2 RNA vaccine candidates against COVID 19 and the efficacy of 1 candidate:
The candidate selected for evaluation in Phase 2/3 is BNT162b2 (mid-dose).
Participants 16 years of age who originally received placebo will be offered the opportunity to receive BNT162b2 at defined points as part of the study.
Condition | *COVID-19, Covid-19, SARS-CoV-2 Infection, SARS-CoV-2 Infection, SARS-CoV-2 Infection, SARS-CoV-2 Infection, SARS-CoV-2 Infection, SARS-CoV-2 Infection, SARS-CoV-2 Infection, SARS-CoV-2 Infection, SARS-CoV-2 Infection, SARS-CoV-2 Infection, SARS-CoV-2 Infection, SARS-CoV-2 Infection, SARS-CoV-2 Infection, SARS-CoV-2 Infection, SARS-CoV-2 Infection, SARS-CoV-2 Infection, SARS-CoV-2 Infection, SARS-CoV-2 Infection, SARS-CoV-2 Infection, SARS-CoV-2 Infection, SARS-CoV-2 Infection, SARS-CoV-2 Infection, SARS-CoV-2 Infection, SARS-CoV-2 Infection, SARS-CoV-2 Infection, SARS-CoV-2 Infection, SARS-CoV-2 Infection, SARS-CoV-2 Infection, SARS-CoV-2 Infection, SARS-CoV-2 Infection, SARS-CoV-2 Infection, SARS-CoV-2 Infection, SARS-CoV-2 Infection, SARS-CoV-2 Infection |
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Treatment | Placebo, BNT162a1, BNT162b1, BNT162b2, BNT162c2, BNT162b3 |
Clinical Study Identifier | NCT04368728 |
Sponsor | BioNTech SE |
Last Modified on | 17 February 2021 |
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