NCT07730450 · BioNTech SE
A Study to Learn About a COVID-19 Vaccine in Healthy Adults 18 Through 64 Years of Age
What this study is 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.
View original scientific description
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.
Interventions
BIOLOGICAL
BNT162b2 Vaccine
Participants will receive a single injection containing variant-adapted BNT162b2 on Day 1.
BIOLOGICAL
Tdap Vaccine
Participants will receive a single injection containing Tdap on Day 1.
Primary outcome measures
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
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- Walnut Creek, California
- Miami Lakes, Florida
- Honolulu, Hawaii
- Durham, North Carolina
- Salt Lake City, Utah
Collaborators
Pfizer
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 7, 2026 · Source of record for eligibility and locations