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 two 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 two different SARS CoV 2 RNA vaccine candidates against COVID-19 and the efficacy of one candidate: a) As a 2-dose (separated by 21 days) schedule; b) At various different dose levels in Phase 1; and c) In three 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).
Target population: Adults ≥ 18 years and older (various age groups)
Locations: Main Street Physician’s Care, Little River and Loris
Further information: Clinicaltrials.gov NCT04368728; 1-800-718-1021, clinicaltrials.gov_Inquiries@pfizer.com
Overview: The purpose of this study is to assess SARS CoV-2 infection, viral shedding, and subsequent potential transmission in university students immunized with the Moderna COVID-19 vaccine.