A Phase 4 interventional study of BNT162b2 Vaccine and Tdap Vaccine in COVID-19 Vaccines, sponsored by BioNTech SE. Recruiting at 5 sites in United States. Open to participants aged 18 Years to 64 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-07.
Sponsored by BioNTech SE · Phase 4, Interventional, and Prevention
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:
All participants in this study will randomly receive 1 injection into their arm of either:
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.
2,044 studies on the registry are indexed under Pneumonia; 283 are open to participants now.
This study's planned enrollment of 200 is above the median of 106 across 1,247 interventional studies indexed under Pneumonia.
Browse Pneumonia studies →BioNTech SE is the lead sponsor of 74 studies on the registry; 23 are open to participants now.
Of its 32 completed or terminated interventional studies of FDA-regulated products, 26 (81%) have results posted.
Counted across the registry records on this site, refreshed daily.
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
The complete list of inclusion and exclusion criteria are listed in the protocol.
Participants will receive a single injection containing variant-adapted BNT162b2 on Day 1.
Biological: BNT162b2 Vaccine
Participants will receive a single injection containing Tdap on Day 1.
Biological: Tdap Vaccine
Participants will receive a single injection containing variant-adapted BNT162b2 on Day 1.
Participants will receive a single injection containing Tdap on Day 1.
Percentage of participants reporting local reactions or systemic events
Time frame: From Day 1 up to 7 days after Vaccination
Percentage of participants reporting adverse events
Time frame: From Day 1 through 1 month after vaccination
Percentage of participants reporting serious adverse events
Time frame: From Day 1 through 12 months after vaccination
Spike protein levels
Time frame: Up to 12 months after vaccination
Plan to share: No
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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BioNTech SE