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A Study of COVID-19 Vaccine(s) in Children and Adults
A PHASE 3 CLINICAL STUDY EVALUATING THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF BNT162B2 RNA-BASED, VARIANT-ADAPTED VACCINE CANDIDATE(S) AGAINST SARS-COV-2 IN CHILDREN AND ADULTS
Who can join
Ages 5 and older · All sexes · Healthy volunteers welcome
Full 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.
About the study
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.
What is being tested
- BNT162b2 (biological)
- BNT162b2 (biological)
- BNT162b2 (biological)
Sponsor: BioNTech SE · Participants: 700 · Started: Aug 31, 2026
Contact the study team
- Pfizer CT.gov Call Center · Phone: 1-800-718-1021
Official record on ClinicalTrials.gov — NCT07798648
Locations in the U.S.
Conditions
- Pneumonia
- Respiratory Tract Infections
- Viral Pneumonia
- Viral Infections
- COVID-19 and Coronavirus Infections
- RNA Virus Infections
- Lung Diseases
- Post-COVID Conditions (Long COVID)
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.