Study to Describe the Safety, Tolerability, Immunogenicity, and Efficacy of RNA Vaccine Candidates Against COVID-19 in Healthy Individuals

2/3期 已完成 NCT04368728

摘要

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. In order to describe the boostability of BNT162, and potential heterologous protection against emerging SARS-CoV-2 VOCs, an additional dose of BNT162b2 at 30 µg will be given to Phase 1 participants approximately 6 to 12 months a

Percentage of Participants With Local Reactions Within 7 Days After Dose 1: Phase 1

Within 7 days after Dose 1 · Percentage of participants

Percentage of Participants With Local Reactions Within 7 Days After Dose 2: Phase 1

Within 7 days after Dose 2 · Percentage of participants

Percentage of Participants With Systemic Events Within 7 Days After Dose 1: Phase 1

Within 7 days after Dose 1 · Percentage of participants

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