Recruiting

BNT162b2

Sponsor:

BioNTech SE

Code:

NCT07730450

Conditions

COVID-19 Vaccines

Eligibility Criteria

Sex: All

Age: 18 - 64

Healthy Volunteers: Accepted

Interventions

BNT162b2 Vaccine

Tdap Vaccine

Study Details

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

Study ID

NCT07730450

Start date

Jul 23, 2026

Status verified date

Aug, 2026

Completion date

Aug 20, 2027

Anticipated

Primary completion date

Aug 20, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 64

Healthy Volunteers: Accepted

Key Inclusion Criteria

\- 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.

Key Exclusion Criteria

  • 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.

The complete list of inclusion and exclusion criteria are listed in the protocol.

Study Design

Enrollment

200 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: BNT162b2 Vaccine

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

active comparator: Tdap Vaccine

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

Interventions

BNT162b2 Vaccine

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

Tdap Vaccine

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

Primary outcome measure

  • Percentage of participants reporting local reactions or systemic events [ Time Frame: From Day 1 up to 7 days after Vaccination ]
  • Percentage of participants reporting adverse events [ Time Frame: From Day 1 through 1 month after vaccination ]
  • Percentage of participants reporting serious adverse events [ Time Frame: From Day 1 through 12 months after vaccination ]
  • Spike protein levels [ Time Frame: Up to 12 months after vaccination ]

Central Contacts and Locations

Central contacts

Pfizer CT.gov Call Center

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

Locations

Diablo Clinical Research, LLC dba Flourish Research

Recruiting

Walnut Creek, California, United States, 94598

Palm Springs Community Health Center

Recruiting

Miami Lakes, Florida, United States, 33014

East-West Medical Research Institute

Recruiting

Honolulu, Hawaii, United States, 96814

Duke Vaccine and Trials Unit

Recruiting

Durham, North Carolina, United States, 27703

J. Lewis Research, Inc. / Foothill Family Clinic

Recruiting

Salt Lake City, Utah, United States, 84109

More Information

Sponsor

BioNTech SE

Last update posted

Aug 7, 2026

Last verified

Aug, 2026

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by BioNTech SE on 2026-08-07.