Study to Describe the Safety, Tolerability, Immunogenicity, and Efficacy of RNA Vaccine Candidates Against COVID-19 in Healthy Adults
What is the purpose of this trial?
This is a Phase 1/2/3, randomized, placebo-controlled, observer-blind, dose-finding, vaccine candidate-selection, and efficacy study in healthy adults.
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:
- As a 2-dose (separated by 21 days) schedule;
- At various different dose levels in Phase 1;
- In 3 age groups (Phase 1: 18 to 55 years of age, 65 to 85 years of age; Phase 2/3: 18 to 85 years of age [stratified as ≤55 or >55 years of age]).
The candidate selected for evaluation in Phase 2/3 is BNT162b2 (mid-dose).
- Ages12 years and older
- Trial withPfizer Inc., U.S. Pharmaceuticals Group
- Start Date08/11/2020
- End Date06/12/2021
- Last Updated10/20/2020
- Study HIC#2000028707