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

Trial status:Will Be Recruiting
Trial ID:
C4591088
NCT ID:
NCT07730450
EudraCT ID:
N/A
EU Trial (CTIS) Number:
N/A
Sponsor:
The sponsor of a clinical trial is the company, institution or individual that takes responsibility for initiating, managing, and/or financing a clinical investigation. BioNTech collaborates with other pharmaceutical companies or institutions (collaborators) to develop certain new medicines. In particular cases BioNTech's collaborators are leading specific clinical trials and are acting as sponsors accordingly.
BioNTech SE
Collaborator:
Pfizer
Will Be Recruiting

Trial Details

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.

Medical Condition
Unmapped
Study Drug
BNT162b2 Vaccine
See more
Tdap Vaccine
Phase
Phase 4
Type
Interventional
Estimated Enrolment
200
Estimated Trial Date
Jul 2026 - Aug 2027

Trial Participant Requirements

Age
18 - 64 Years
Sex
Female & Male
Healthy Volunteers
Yes
Inclusion and Exclusion Criteria
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 exclusion criteria are listed in the protocol.

Trial Locations

Location
Status
Location
Diablo Clinical Research, LLC dba Flourish Research
Walnut Creek, California, United States, 94598
Status
Location
Palm Springs Community Health Center
Miami Lakes, Florida, United States, 33014
Status
Location
East-West Medical Research Institute
Honolulu, Hawaii, United States, 96814
Status
Location
J. Lewis Research, Inc. / Foothill Family Clinic
Salt Lake City, Utah, United States, 84109
Status