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

BioNTech

Status and phase: Enrolling; Phase 4

Conditions: COVID-19 Vaccines

Treatments: Biological: BNT162b2 Vaccine; Biological: Tdap Vaccine

Study type: Interventional

Funder types: Industry

Identifiers

NCT07730450

C4591088

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 64 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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 exclusion criteria are listed in the protocol.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

BNT162b2 Vaccine

Experimental group

Description:

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

Treatment:

Biological: BNT162b2 Vaccine

Tdap Vaccine

Active Comparator group

Description:

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

Treatment:

Biological: Tdap Vaccine