A Study to Learn About a COVID-19 Vaccine in Healthy Adults 18 Through 64 Years of Age

NCT07730450 | Not Yet Recruiting Phase 4 FDA Drug

• 1 other identifier: C4591088
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 4

Brief Summary

The purpose of this study is to learn about the safety and effects of an updated COVID-19 vaccine (called BNT162b2) in adults 18 to 64 years of age. This study is seeking participants who:

• are medically stable
• have not had a recent COVID-19 infection
• have not had a recent vaccination
• do not have medical conditions that increase their risk of complications from COVID-19 All participants in this study will randomly receive 1 injection into their arm of either:
• BNT162b2 vaccine which targets COVID-19 and is selected for the 2026-2027 COVID-19 season, or
• Tdap vaccine which targets tetanus, diphtheria, and pertussis (whooping cough). The study team and participants will not know which injection they receive. We will evaluate safety and SARS-CoV-2 spike protein levels in people receiving each of these vaccines. Participants will be in the study for about 12 months.

Conditions

COVID-19 Vaccines

Keywords

Pneumonia; Pneumonia, Viral; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; COVID-19; mRNA Vaccines; Nucleic Acid-Based Vaccines; 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

  From Day 1 up to 7 days after Vaccination

• Percentage of participants reporting adverse events

  From Day 1 through 1 month after vaccination

• Percentage of participants reporting serious adverse events

  From Day 1 through 12 months after vaccination

• Spike protein levels

  Up to 12 months after vaccination

Study Arms (2)

Tdap Vaccine

ACTIVE COMPARATOR

Participants will receive a single injection containing Tdap on Day 1.

Biological: Tdap Vaccine

BNT162b2 Vaccine

EXPERIMENTAL

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

Biological: BNT162b2 Vaccine

Interventions

BNT162b2 Vaccine BIOLOGICAL

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

BNT162b2 Vaccine

Tdap Vaccine BIOLOGICAL

Participants will receive a single injection containing Tdap on Day 1.

Tdap Vaccine

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• \- Healthy participants 18 through 64 years of age who do not have medical conditions that put them at a higher risk for severe COVID-19.

You may not qualify if:

• Participants who tested positive for COVID-19 within 6 months (180 days) prior to Visit 1
• Participants who have recently received a vaccine, or plan to receive a nonstudy COVID-19 or comparator vaccine during participation.

Sponsors & Collaborators

• BioNTech SE: lead
• Pfizer: collaborator

Study Sites (4)

Diablo Clinical Research, LLC dba Flourish Research

Walnut Creek, California, 94598, United States

Location

Palm Springs Community Health Center

Miami Lakes, Florida, 33014, United States

Location

East-West Medical Research Institute

Honolulu, Hawaii, 96814, United States

Location

J. Lewis Research, Inc. / Foothill Family Clinic

Salt Lake City, Utah, 84109, United States

Location

Related Links

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

MeSH Terms

Conditions

Pneumonia; Pneumonia, Viral; Respiratory Tract Infections; 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 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double-Blind, Third-Party-Unblinded
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 23, 2026
• First Posted: July 28, 2026
• Study Start: July 23, 2026
• Primary Completion (Estimated): August 6, 2027
• Study Completion (Estimated): August 6, 2027
• Last Updated: July 28, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)