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

Study 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. * 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 C: * This study will evaluate the safety, tolerability, and immunogenicity of BNT162b2 (Omi JN.1) and BNT162b2 (Omi KP.2) given as a single 30 µg dose to: * Cohort 1: people who are 18 years of age and older, who will receive BNT162b2 (Omi JN.1), and, * Cohort 2: people who are 12 years of age and older, who will receive BNT162b2 (Omi JN.1), and, * Cohort 3: people who are 18 years of age and older who will receive BNT162b2 (Omi KP.2). * Participants may have never received a COVID-19 vaccine or, may have previously received COVID-19 vaccine(s), with the most recent dose received at least 150 days before the stu

Primary Outcome

Local reactions: pain at injection site, redness and swelling were recorded by participants in an electronic diary (e-diary) or as adverse events (AEs) in the case report form (CRF). Redness and swelling were recorded in measuring device units (mdu) (range: 1 to 21), 1 mdu =0.5 centimeter (cm) and were graded as mild (greater than \[\>\] 2.0 to 5.0 cm), moderate (\>5.0 to 10.0 cm), severe (\>10.0 cm) and Grade 4 (necrosis \[swelling\] and necrosis or exfoliative dermatitis \[redness\]). Pain at

Conditions Studied

Interventions

• BIOLOGICAL BNT162b2 (Omi XBB.1.5)
• BIOLOGICAL BNT162b2 (Omi JN.1)
• BIOLOGICAL BNT162b2 (Omi KP.2)

Study Locations (20)