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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

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
None (Open Label)
Masking Description
Double-Blind, Third-Party-Unblinded

Arm Groups

ArmDescriptionAssigned Intervention
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.
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.

Recruiting Locations

Diablo Clinical Research, LLC dba Flourish Research
Walnut Creek, California 94598

Palm Springs Community Health Center
Miami Lakes, Florida 33014

East-West Medical Research Institute
Honolulu, Hawaii 96814

Duke Vaccine and Trials Unit
Durham, North Carolina 27703

J. Lewis Research, Inc. / Foothill Family Clinic
Salt Lake City, Utah 84109

More Details

Status
Recruiting
Sponsor
BioNTech SE

Study Contact

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

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.