A Study to Learn About New COVD-19 RNA Vaccine Candidates for New Variants in Healthy Individuals

Phase 2/3 Completed NCT05997290

Summary

The purpose of this clinical protocol is to learn about the safety, tolerability, and immunogenicity of new BNT162b2 RNA-based vaccine candidates targeting new variants of SARS-CoV-2 in healthy people. Substudy A: * This study will evaluate the safety, tolerability, and immunogenicity of BNT162b2 (Omi XBB.1.5) given as a single 30 µg dose, * in people who are 12 years of age and older, * who previously received at least 3 doses of a US-authorized mRNA COVID-19 vaccine, with the most recent dose being an Omicron BA.4/BA.5-adapted bivalent vaccine received at least 150 days before the study vaccination (Visit 1). * The study is about 6 months long for each participant. * Participants will have at least 5 visits to the clinic. * At each clinic visit a blood sample will be taken. * At least 1 nasal swab will taken. Substudy B: * This study will evaluate the safety, tolerability, and immunogenicity of BNT162b2 (Omi XBB.1.5) given as a single 30 µg dose, * in people who are 12 years of age and older, * who are COVID-19 vaccine-naïve * who have had any positive SARS-CoV-2 test result \>28 days before study vaccine administration. * The study is about 6 months long for each participant. *

Percentage of Participants With Local Reactions Within 7 Days After Vaccination: SSA

Day 1 to Day 7 after vaccination · Percentage of participants

Percentage of Participants With Systemic Events Within 7 Days After Vaccination: SSA

Day 1 to Day 7 after vaccination · Percentage of participants

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

From vaccination on Day 1 up to 1 month after vaccination · Percentage of participants

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