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NCT Number: NCT07730450

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

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.

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Key information

Conditions

COVID-19 Vaccines COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Diablo Clinical Research, LLC dba Flourish Research, Walnut Creek, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

BNT162b2 Vaccine

Biological

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

Tdap vaccine

Biological

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

Primary outcomes

  1. Percentage of participants reporting local reactions or systemic events

    Time frame: From Day 1 up to 7 days after Vaccination

  2. Percentage of participants reporting adverse events

    Time frame: From Day 1 through 1 month after vaccination

  3. Percentage of participants reporting serious adverse events

    Time frame: From Day 1 through 12 months after vaccination

  4. Spike protein levels

    Time frame: Up to 12 months after vaccination

Study contacts

Contact information is provided by the study sponsor or research team.

Pfizer CT.gov Call Center

CONTACT

[email protected]

1-800-718-1021

Sponsors and collaborators

Lead sponsor

BioNTech SE

Industry

Collaborators

  • Pfizer

Registry information

Official study title

A PHASE 4, RANDOMIZED, DOUBLE-BLIND, THIRD-PARTY-UNBLINDED STUDY TO INVESTIGATE THE SAFETY AND TOLERABILITY OF A BNT162B2 RNA-BASED, VARIANT-ADAPTED VACCINE CANDIDATE AGAINST SARS-COV-2 AND EVALUATE THE CIRCULATING SARS-COV-2 SPIKE PROTEIN LEVEL IN HEALTHY PARTICIPANTS 18 THROUGH 64 YEARS OF AGE

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jul 28, 2026
Registry last updated
Jul 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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