BNT162b2 Vaccine for COVID-19
Trial Summary
What is the purpose of this trial?
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 study vaccination (Visit 1). * The study is about 6 months long for each participant. * Participants will have at least 6 visits (Cohorts 1 and 3) or at least 5 visits (Cohort 2) to the clinic. * At each clinic visit a blood sample will be taken. * At least 1 nasal swab will taken.
Research Team
Pfizer CT.gov Call Center
Principal Investigator
Pfizer
Eligibility Criteria
This trial is for healthy individuals aged 12 and older. Substudy A includes those who've had at least 3 doses of a US-authorized mRNA COVID-19 vaccine, with the last being an Omicron BA.4/BA.5-adapted bivalent vaccine over 150 days ago. Substudy B is for COVID-19 vaccine-naïve people who tested positive for SARS-CoV-2 more than 28 days before.Inclusion Criteria
Treatment Details
Interventions
- BNT162b2 (Omi XBB.1.5)
Find a Clinic Near You
Who Is Running the Clinical Trial?
BioNTech SE
Lead Sponsor
Prof. Dr. Ugur Sahin
BioNTech SE
Chief Executive Officer since 2008
MD from University of Cologne
Prof. Özlem Türeci
BioNTech SE
Chief Medical Officer since 2018
MD from Saarland University
Pfizer
Industry Sponsor
Albert Bourla
Pfizer
Chief Executive Officer since 2019
PhD in Biotechnology of Reproduction, Aristotle University of Thessaloniki
Patrizia Cavazzoni
Pfizer
Chief Medical Officer
MD from McGill University