Eligibility

icon smiley face Healthy icon adult Adults

Overview

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).

Details

IRB Number
202004789
NCT Number
NCT04368728
Study Status
Open
Study Type
Interventional
Primary Purpose
Prevention
Phase
Phase 2/Phase 3
Cancer Study
No
Compensation Available
Yes

Principal Investigator

Patricia Winokur
Medicine Administration