RECRUITING Phase 3 ClinicalTrials.gov

A Study of COVID-19 Vaccine(s) in Children and Adults

Sponsor: BioNTech SE • ClinicalTrials.gov ID: NCT07798648

Registry updated: 2026-09-28

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Description

The purpose of this study is to learn about the safety and effects of updated COVID-19 vaccines (called BNT162b2) in participants 5 Through 64 Years of Age with risk factors for Severe COVID-19, and Participants 65 Years of Age and Older. This study is seeking participants who: * are medically stable * have not had a recent COVID-19 infection or a recent COVID-19 vaccination * have not received certain routine vaccines recently * participants that are 5 through 64 years of age will need to have at least 1 medical condition that increase their risk of complications from COVID-19. Participants in Cohort 1 of this study will receive a single age-appropriate dose (30 mcg for participants aged ≥12 years; 10 mcg for participants aged 5-11 years) of BNT162b2 vaccine 1 which targets COVID-19 (2026/2027 recommended strain) injected in the upper arm. The study team and participants will know which injection they receive. Participants in Cohort 2 of this study will randomly receive 1 injection into their upper arm of either: BNT162b2 vaccine 1; BNT162b2 vaccine 2, or BNT162b2 vaccine 3 which targets COVID-19. The study team and participants will not know which injection they receive. Participants will be in the study for about 6 months and will have at least 3 study visits. Participants will record side effects and complete diaries following visit procedures. For Cohort 1 the study team will collect a nose swab and blood samples at 2 of the 3 visits. For Cohort 2 the study team will collect a nose swab and blood samples at all of the visits.

Interventions

BNT162b2 (Biological)
BNT162b2 vaccine 1 (2026/2027 recommended strain)
BNT162b2 (Biological)
BNT162b2 vaccine 2
BNT162b2 (Biological)
BNT162b2 vaccine 3

Eligibility criteria

Key Inclusion criteria: * Participants 5 years of age or older. * Participants 5 through 64 years of age should have at least 1 underlying medical condition that increases their risk of severe COVID-19. Key Exclusion Criteria: * History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the study intervention(s). * History of myocarditis or pericarditis. * Receipt of a COVID-19 vaccine or a confirmed case of COVID-19 (confirmed by signs/symptoms and/or a positive test result based on local testing) less than 3 months (90 days) prior to study enrolment. Refer to the study contact for further eligibility details.

Conditions

COVID-19 Vaccines

Locations

C & R Research Servcies USA, Inc. — Homestead, Florida, United States
Indago Research & Health Center, Inc — Miami Lakes, Florida, United States
AGILE Clinical Research Trials, LLC — Atlanta, Georgia, United States
East-West Medical Research Institute — Honolulu, Hawaii, United States
Kentucky Pediatric /Adult Research — Bardstown, Kentucky, United States
Dayton Clinical Research — Dayton, Ohio, United States
Senders Pediatrics — South Euclid, Ohio, United States
DM Clinical Research — Philadelphia, Pennsylvania, United States
Cedar Health Research — Dallas, Texas, United States
Cedar Health Research — Euless, Texas, United States
DM Clinical Research-Cyfair — Houston, Texas, United States
DM Clinical Research — Tomball, Texas, United States
J. Lewis Research, Inc. / Foothill Family Clinic — Salt Lake City, Utah, United States
J. Lewis Research, Inc. / Foothill Family Clinic South — Salt Lake City, Utah, United States

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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