COVID-19 VaccinesPhase 4NCT07730450
A Study to Learn About a COVID-19 Vaccine in Healthy Adults 18 Through 64 Years of Age
A Phase 4 study testing BNT162b2 Vaccine and Tdap Vaccine in people with COVID-19 Vaccines, run by BioNTech SE at 5 sites in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- COVID-19 Vaccines
- What is being tested?
- BNT162b2 Vaccine and Tdap Vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 5 sitesUnited States
- Study dates
- 23 Jul 2026to 20 Aug 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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 and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
United States5 sites, 5 recruiting
- Recruiting
Duke Vaccine and Trials Unit
Durham, North Carolina, 27703
- Recruiting
East-West Medical Research Institute
Honolulu, Hawaii, 96814
- Recruiting
Palm Springs Community Health Center
Miami Lakes, Florida, 33014
- Recruiting
J. Lewis Research, Inc. / Foothill Family Clinic
Salt Lake City, Utah, 84109
- Recruiting
Diablo Clinical Research, LLC dba Flourish Research
Walnut Creek, California, 94598
About this study
Official title: A PHASE 4, RANDOMIZED, DOUBLE-BLIND, THIRD-PARTY-UNBLINDED STUDY TO INVESTIGATE THE SAFETY AND TOLERABILITY OF A BNT162B2 RNA-BASED, VARIANT-ADAPTED VACCINE CANDIDATE AGAINST SARS-COV-2 AND EVALUATE THE CIRCULATING SARS-COV-2 SPIKE PROTEIN LEVEL IN HEALTHY PARTICIPANTS 18 THROUGH 64 YEARS OF AGE
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:
Read more
- 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.
- Conditions
- COVID-19 Vaccines
- Being tested
- BNT162b2 Vaccine, Tdap Vaccine
- Keywords
- Pneumonia, Pneumonia, Viral, Respiratory Tract Infections, Infections, Virus Diseases, Coronavirus Infections, Coronaviridae Infections, Nidovirales Infections, RNA Virus Infections, Lung Diseases, Respiratory Tract Diseases, COVID-19, mRNA Vaccines, Nucleic Acid-Based Vaccines, Vaccines, Synthetic, Recombinant Proteins, Proteins, Amino Acids, Peptides, and Proteins, Vaccines, Biological Products
- Medical subject headings
- Pneumonia, Pneumonia, Viral, Respiratory Tract Infections, Infections, Virus Diseases, Coronavirus Infections, Coronaviridae Infections, Nidovirales Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BNT162b2 VaccineBiological
Participants will receive a single injection containing variant-adapted BNT162b2 on Day 1.
Tdap VaccineBiological
Participants will receive a single injection containing Tdap on Day 1.
| Study group | Role | What they receive |
|---|---|---|
| BNT162b2 Vaccine | Experimental | Participants will receive a single injection containing variant-adapted BNT162b2 on Day 1. Receives: Biological: BNT162b2 Vaccine |
| Tdap Vaccine | Active comparator | Participants will receive a single injection containing Tdap on Day 1. Receives: Biological: Tdap Vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of participants reporting local reactions or systemic events
Measured: From Day 1 up to 7 days after Vaccination
Percentage of participants reporting adverse events
Measured: From Day 1 through 1 month after vaccination
Percentage of participants reporting serious adverse events
Measured: From Day 1 through 12 months after vaccination
Spike protein levels
Measured: Up to 12 months after vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2026
- Study start23 Jul 2026
- Primary completion20 Aug 2027 (estimated)
- Study completion20 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19 VaccinesStudies of the same condition, open and under way.
- More trials run by BioNTech SEThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- BioNTech SE
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Pfizer
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07730450
- Sponsor's protocol ID
- C4591088
- Status last verified
- Aug 2026
- First submitted
- 23 Jul 2026
- Last updated
- 7 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A PHASE 4, RANDOMIZED, DOUBLE-BLIND, THIRD-PARTY-UNBLINDED STUDY TO INVESTIGATE THE SAFETY AND TOLERABILITY OF A BNT162B2 RNA-BASED, VARIANT-ADAPTED VACCINE CANDIDATE AGAINST SARS-COV-2 AND EVALUATE THE CIRCULATING SARS-COV-2 SPIKE PROTEIN LEVEL IN HEALTHY PARTICIPANTS 18 THROUGH 64 YEARS OF AGE
- ClinicalTrials.gov ID
- NCT07730450
- Acronym / sponsor ID
- C4591088
- Conditions
- COVID-19 Vaccines
- Keywords
- Pneumonia, Pneumonia, Viral, Respiratory Tract Infections, Infections, Virus Diseases, Coronavirus Infections, Coronaviridae Infections, Nidovirales Infections
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- BioNTech SEIndustry (pharma, biotech, devices)
- Collaborators
- Pfizer
- Study start
- 23 Jul 2026 (actual)
- Primary completion
- 20 Aug 2027 (estimated)
- Study completion
- 20 Aug 2027 (estimated)
- First posted
- 28 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BNT162b2 Vaccine | Experimental | Biological: BNT162b2 VaccineParticipants will receive a single injection containing variant-adapted BNT162b2 on Day 1. |
| Tdap Vaccine | Active comparator | Biological: Tdap VaccineParticipants will receive a single injection containing Tdap on Day 1. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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 (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BNT162b2 VaccineParticipants will receive a single injection containing variant-adapted BNT162b2 on Day 1. | Biological | BNT162b2 Vaccine |
| Tdap VaccineParticipants will receive a single injection containing Tdap on Day 1. | Biological | Tdap Vaccine |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2026.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Pfizer CT.gov Call Center study director
Pfizer
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing BNT162b2 Vaccine and Tdap Vaccine in people with COVID-19 Vaccines, run by BioNTech SE at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pfizer CT.gov Call Center (1-800-718-1021, ClinicalTrials.gov_Inquiries@pfizer.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of participants reporting local reactions or systemic events (time frame: From Day 1 up to 7 days after Vaccination). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2026.