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

NCT07798648 | Recruiting Phase 3 DMC FDA Drug

• 1 other identifier: C4591083
• Study Type: interventional
• Target: 700
• Locations: 1 country
• Sites: 14

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

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

Outcome Measures

Primary Outcomes (4)

• Percentage of participants reporting local reactions or systemic events

  For up to 7 days after vaccination

• Percentage of participants reporting adverse events

  Through 1 month after vaccination

• Percentage of participants reporting serious adverse events

  Through 6 months after vaccination

• Geometric Mean Fold Rise (GMFRs)

  From baseline to 1 month after vaccination

Secondary Outcomes (2)

• Geometric Mean Titers (GMTs)

  At baseline and at 1 month after vaccination

• Percentage of participants with seroresponse

  At 1 month after vaccination

Study Arms (9)

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

EXPERIMENTAL

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

Biological: BNT162b2

Cohort 1 Group 3: ≥65 Years

EXPERIMENTAL

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

Biological: BNT162b2

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

EXPERIMENTAL

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

Biological: BNT162b2

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

EXPERIMENTAL

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

Biological: BNT162b2

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

EXPERIMENTAL

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

Biological: BNT162b2

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

EXPERIMENTAL

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

Biological: BNT162b2

Cohort 2 Group 7: ≥65 Years

EXPERIMENTAL

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

Biological: BNT162b2

Cohort 2 Group 8: ≥65 Years

EXPERIMENTAL

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

Biological: BNT162b2

Cohort 2 Group 9: ≥65 Years

EXPERIMENTAL

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

Biological: BNT162b2

Interventions

BNT162b2 BIOLOGICAL

BNT162b2 vaccine 1 (2026/2027 recommended strain)

Cohort 1 Group 1: 5-11 Years (with risk factors); Cohort 1 Group 2: 12-64 Years (with risk factors); Cohort 1 Group 3: ≥65 Years; Cohort 2 Group 4: 18-64 Years (with risk factors); Cohort 2 Group 7: ≥65 Years

Eligibility Criteria

• Age: 5 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You 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 may not qualify 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.

Sponsors & Collaborators

• BioNTech SE: lead
• Pfizer: collaborator

Study Sites (14)

C & R Research Servcies USA, Inc.

Homestead, Florida, 33030, United States

RECRUITING

Indago Research & Health Center, Inc

Miami Lakes, Florida, 33016, United States

RECRUITING

AGILE Clinical Research Trials, LLC

Atlanta, Georgia, 30328, United States

RECRUITING

East-West Medical Research Institute

Honolulu, Hawaii, 96814, United States

RECRUITING

Kentucky Pediatric /Adult Research

Bardstown, Kentucky, 40004, United States

RECRUITING

Dayton Clinical Research

Dayton, Ohio, 45409, United States

RECRUITING

Senders Pediatrics

South Euclid, Ohio, 44121, United States

RECRUITING

DM Clinical Research

Philadelphia, Pennsylvania, 19107, United States

RECRUITING

Cedar Health Research

Dallas, Texas, 75251, United States

RECRUITING

Cedar Health Research

Euless, Texas, 76040, United States

RECRUITING

DM Clinical Research-Cyfair

Houston, Texas, 77065, United States

RECRUITING

DM Clinical Research

Tomball, Texas, 77375, United States

RECRUITING

J. Lewis Research, Inc. / Foothill Family Clinic

Salt Lake City, Utah, 84109, United States

RECRUITING

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

Salt Lake City, Utah, 84121, United States

RECRUITING

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

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

Interventions

BNT162 Vaccine

Intervention Hierarchy (Ancestors)

mRNA Vaccines; Nucleic Acid-Based Vaccines; Vaccines, Synthetic; Recombinant Proteins; Proteins; Amino Acids, Peptides, and Proteins; Vaccines; Biological Products; Complex Mixtures; COVID-19 Vaccines; Viral Vaccines; Antigens; Biological Factors

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Central Study Contacts

Pfizer CT.gov Call Center

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Cohort 1 - No Masking; Cohort 2 - Masking applies: Double Blind, Third-party Unblinded (Participant, Care Provider, Investigator)
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 28, 2026
• First Posted: September 1, 2026
• Study Start: August 31, 2026
• Primary Completion (Estimated): April 21, 2027
• Study Completion (Estimated): April 21, 2027
• Last Updated: September 28, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (14)