What this study is
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's being tested
- BNT162b2
Intervention · BIOLOGICAL
BNT162b2 vaccine 1 (2026/2027 recommended strain)
- BNT162b2
Intervention · BIOLOGICAL
BNT162b2 vaccine 2
- BNT162b2
Intervention · BIOLOGICAL
BNT162b2 vaccine 3
Study details
- Official title
- 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
- Sponsor
- BioNTech SE
- Conditions
- COVID-19 Vaccines
- Enrolling
- 700 people
- Starts
- 2026-08-31
- Est. completion
- 2027-04-21
- Design
- Triple-blind, randomized, parallel groups, Phase 3
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 5 Years and overSex ALLHealthy volunteers AcceptedYou may qualify if
- 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.
You can't join if
- 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.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (14)
14 openC & R Research Servcies USA, Inc.
Homestead, Florida, United States
RecruitingIndago Research & Health Center, Inc
Miami Lakes, Florida, United States
RecruitingAGILE Clinical Research Trials, LLC
Atlanta, Georgia, United States
RecruitingEast-West Medical Research Institute
Honolulu, Hawaii, United States
RecruitingKentucky Pediatric /Adult Research
Bardstown, Kentucky, United States
RecruitingDayton Clinical Research
Dayton, Ohio, United States
RecruitingSenders Pediatrics
South Euclid, Ohio, United States
RecruitingDM Clinical Research
Philadelphia, Pennsylvania, United States
RecruitingCedar Health Research
Dallas, Texas, United States
RecruitingCedar Health Research
Euless, Texas, United States
RecruitingDM Clinical Research-Cyfair
Houston, Texas, United States
RecruitingDM Clinical Research
Tomball, Texas, United States
RecruitingJ. Lewis Research, Inc. / Foothill Family Clinic
Salt Lake City, Utah, United States
RecruitingJ. Lewis Research, Inc. / Foothill Family Clinic South
Salt Lake City, Utah, United States
Recruiting
Study team
Sponsor
BioNTech SE
Study ID C4591083
Study director
Pfizer CT.gov Call Center
Pfizer
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.