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

Purpose

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.

Condition

  • COVID-19 Vaccines

Eligibility

Eligible Ages
Between 18 Years and 64 Years
Eligible Sex
All
Accepts Healthy Volunteers
Yes

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.

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

Phase
Phase 4
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Prevention
Masking
Double (Participant, Investigator)
Masking Description
Double-Blind, Third-Party-Unblinded

Arm Groups

ArmDescriptionAssigned Intervention
Active Comparator
Tdap Vaccine 		Participants will receive a single injection containing Tdap on Day 1.
  • Biological: Tdap Vaccine
    Participants will receive a single injection containing Tdap on Day 1.
Experimental
BNT162b2 Vaccine 		Participants will receive a single injection containing variant-adapted BNT162b2 on Day 1.
  • Biological: BNT162b2 Vaccine
    Participants will receive a single injection containing variant-adapted BNT162b2 on Day 1.

Recruiting Locations

More Details

NCT ID
NCT07730450
Status
Not yet recruiting
Sponsor
BioNTech SE

Study Contact

Pfizer CT.gov Call Center
1-800-718-1021
ClinicalTrials.gov_Inquiries@pfizer.com