This document was first posted April 30 2020.
"Study Overview
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 3 different SARS-CoV-2 RNA vaccine candidates against COVID-19 and the efficacy of 1 candidate:
- As a 2-dose (separated by 21 days) schedule;
- At various different dose levels in Phase 1;
- As a booster;
- In 3 age groups (Phase 1: 18 to 55 years of age, 65 to 85 years of age; Phase 2/3: ≥12 years of age [stratified as 12-15, 16-55 or >55 years of age]).
The candidate selected for efficacy evaluation in Phase 2/3 is BNT162b2 at a dose of 30 µg.
Participants who originally received placebo will be offered the opportunity to receive BNT162b2 at defined points as part of the study....
Intervention/Treatment
- Biological: BNT162b1
- Biological: BNT162b2
- Other: Placebo
- Biological: BNT162b2SA
Eligibility Criteria
... Inclusion Criteria:
• Male or female participants between the ages of 18 and 55 years, inclusive, 65 and 85 years, inclusive, or ≥12 years, inclusive, at randomization (dependent upon study phase)..."
Study Start (Actual): 2020-04-29
Primary Completion (Actual): 2023-02-10
Study Completion (Actual): 2023-02-10