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

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

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07730450

Enrollment

200

Registered

2026-07-28

Start date

2026-07-23

Completion date

2027-08-20

Last updated

2026-08-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

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.

Interventions

BIOLOGICALBNT162b2 Vaccine

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

BIOLOGICALTdap Vaccine

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Masking description

Double-Blind, Third-Party-Unblinded

Eligibility

Sex/Gender

ALL

Age

18 Years to 64 Years

Healthy volunteers

Yes

Inclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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

Countries

United States

Contacts

CONTACTPfizer CT.gov Call Center

ClinicalTrials.gov_Inquiries@pfizer.com1-800-718-1021

STUDY_DIRECTORPfizer CT.gov Call Center

Pfizer

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 8, 2026