A Study to Learn About New COVID-19 RNA Vaccine Candidates in COVID-19 Vaccine-Experienced Healthy Individuals

2/3期 已完成 NCT05472038

摘要

The purpose of this clinical trial is to learn about the safety, tolerability and immunogenicity of BNT162b RNA-based SARS-CoV-2 vaccine candidates in adults to prevent COVID-19. For all cohorts (groups of participants), this study is seeking participants who are healthy (who may have preexisting disease if it is stable); All participants will receive a single dose of the study vaccine at the first study clinic and will return to the study clinic at least 4 more times. At each clinic visit, a blood sample will be taken. The study is about 6 months long for each participant. The vaccine candidates in this study are investigational but are very similar to BNT162b2 (Comirnaty), a COVID-19 RNA vaccine approved for use in the US and in many countries. For Cohort 1, this study included participants who were: * 18 through 55 years of age * have received 1 booster dose of a US-authorized COVID-19 vaccine, with the last dose being 90 or more days before Visit 1 of this study. All participants in Cohort 1 will receive 1 of the 2 study vaccines at a 30 microgram dose: BNT162b5 Bivalent (WT/OMI BA.2) or BNT162b2 Bivalent (WT/OMI BA.1). For Cohort 2, this study included participants who were: *

Cohort 1: Percentage of Participants Reporting Local Reactions Within 7 Days After Study Vaccination

From Day 1 to Day 7 after study vaccination · Percentage of participants

Cohort 1: Percentage of Participants Reporting Systemic Events Within 7 Days After Study Vaccination

From Day 1 to Day 7 after study vaccination · Percentage of participants

Cohort 1: Percentage of Participants With Adverse Events (AEs) From Study Vaccination Through 1 Month After Study Vaccination

From study vaccination on Day 1 through 1 month after study vaccination · Percentage of participants

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