Recruiting
Phase 3

BNT162b2

Sponsor:

BioNTech SE

Code:

NCT07798648

Conditions

COVID-19 Vaccines

Eligibility Criteria

Sex: All

Age: 5+

Healthy Volunteers: Accepted

Interventions

BNT162b2

BNT162b2

BNT162b2

Study Details

Brief summary:

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.

Conditions

COVID-19 Vaccines

Study ID

NCT07798648

Start date

Aug 31, 2026

Status verified date

Sep, 2026

Completion date

Apr 21, 2027

Anticipated

Primary completion date

Apr 21, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 5+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

700 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Cohort 1 Group 1: 5-11 Years (with risk factors)

Participants will receive a single injection (age appropriate dose) on Day 1

experimental: Cohort 1 Group 3: ≥65 Years

Participants will receive a single injection (age appropriate dose) on Day 1.

experimental: Cohort 1 Group 2: 12-64 Years (with risk factors)

Participants will receive a single injection (age appropriate dose) on Day 1

experimental: Cohort 2 Group 5: 18-64 Years (with risk factors)

Participants will receive a single injection containing variant-adapted BNT162b2 on Day 1

experimental: Cohort 2 Group 4: 18-64 Years (with risk factors)

Participants will receive a single injection containing variant-adapted BNT162b2 on Day 1

experimental: Cohort 2 Group 6: 18-64 Years (with risk factors)

Participants will receive a single injection containing variant-adapted BNT162b2 on Day 1

experimental: Cohort 2 Group 7: ≥65 Years

Participants will receive a single injection containing variant-adapted BNT162b2 on Day 1

experimental: Cohort 2 Group 8: ≥65 Years

Participants will receive a single injection containing variant-adapted BNT162b2 on Day 1

experimental: Cohort 2 Group 9: ≥65 Years

Participants will receive a single injection containing variant-adapted BNT162b2 on Day 1

Interventions

BNT162b2

BNT162b2 vaccine 1 (2026/2027 recommended strain)

BNT162b2

BNT162b2 vaccine 2

BNT162b2

BNT162b2 vaccine 3

Primary outcome measure

  • Percentage of participants reporting local reactions or systemic events [ Time Frame: For up to 7 days after vaccination ]
  • Percentage of participants reporting adverse events [ Time Frame: Through 1 month after vaccination ]
  • Percentage of participants reporting serious adverse events [ Time Frame: Through 6 months after vaccination ]
  • Geometric Mean Fold Rise (GMFRs) [ Time Frame: From baseline to 1 month after vaccination ]

Central Contacts and Locations

Central contacts

Pfizer CT.gov Call Center

1-800-718-1021ClinicalTrials.gov_Inquiries@pfizer.com

Locations

C & R Research Servcies USA, Inc.

Recruiting

Homestead, Florida, United States, 33030

Indago Research & Health Center, Inc

Recruiting

Miami Lakes, Florida, United States, 33016

AGILE Clinical Research Trials, LLC

Recruiting

Atlanta, Georgia, United States, 30328

East-West Medical Research Institute

Recruiting

Honolulu, Hawaii, United States, 96814

Kentucky Pediatric /Adult Research

Recruiting

Bardstown, Kentucky, United States, 40004

Dayton Clinical Research

Recruiting

Dayton, Ohio, United States, 45409

Senders Pediatrics

Recruiting

South Euclid, Ohio, United States, 44121

DM Clinical Research

Recruiting

Philadelphia, Pennsylvania, United States, 19107

Cedar Health Research

Recruiting

Dallas, Texas, United States, 75251

Cedar Health Research

Recruiting

Euless, Texas, United States, 76040

DM Clinical Research-Cyfair

Recruiting

Houston, Texas, United States, 77065

DM Clinical Research

Recruiting

Tomball, Texas, United States, 77375

J. Lewis Research, Inc. / Foothill Family Clinic

Recruiting

Salt Lake City, Utah, United States, 84109

J. Lewis Research, Inc. / Foothill Family Clinic South

Recruiting

Salt Lake City, Utah, United States, 84121

More Information

Sponsor

BioNTech SE

Last update posted

Sep 28, 2026

Last verified

Sep, 2026

Keywords

  • Pneumonia
  • Respiratory Tract Infections
  • Pneumonia,Viral
  • Infections
  • Virus Diseases
  • Coronavirus Infections
  • Coronaviridae Infections
  • Nidovirales Infections
  • RNA Virus Infections
  • Lung Diseases
  • Respiratory Tract Diseases
  • COVID-19
  • mRNA Vaccines
  • Nucleic Acid-Based Vaccine
  • Vaccines, Synthetic
  • Recombinant Proteins
  • Proteins
  • Amino Acids, Peptides, and Proteins
  • Vaccines
  • Biological Products
  • COVID-19 Vaccines
  • Viral Vaccines
  • Antigens
  • Biological Factors
  • BNT162 Vaccine

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-29. This information was provided to ClinicalTrials.gov by BioNTech SE on 2026-09-28. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.