AdultPhase 3NCT07819097
A Study to Learn About the Safety and Immune Responses of RSVpreF in Older Adults
A Phase 3 study testing RSVpreF in people with Adult and Healthy Participants, run by Pfizer at 15 sites in 2 countries.
Trial summary
The purpose of this study is to learn about the safety, tolerability, and immune response of the RSVpreF vaccine in healthy older adults. Participants will take part in this study for about 6 months. The study will include people in China and the United States. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Adult, Healthy Participants
- What is being tested?
- RSVpreF
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 600 participants
- Where
- 15 sitesin 2 countries
- Study dates
- 9 Sep 2026to 16 May 2027
- Phase
- Phase 3
- 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 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participants 60 years of age or older at enrolment.
- Healthy participants, or participants with stable long-term medical conditions, if the investigator decides they can take part.
- Adults who can walk and live in the community or in assisted-living/long-term care settings with minimal help.
- Participants who can give signed informed consent and follow study visits and procedures, including the 7-day electronic diary and blood tests.
Who cannot join
- Confirmed RSV infection 180 days or less before study vaccination.
- Any past history of Guillain-Barré syndrome.
- Severe reaction to a vaccine or severe allergy to a study vaccine component or related vaccine.
- Serious or unstable medical condition that the investigator believes makes the study unsafe.
- Immunocompromised status, based on medical history and/or examination.
- Previous receipt of any licensed or investigational RSV vaccine or RSV preventive monoclonal antibody, or planned receipt during the study.
- Please refer to the study contact for further eligibility details Contacts/Locations Central Contact Person: Pfizer CT.gov Call Center Telephone: 1-800-718-1021 Email: ClinicalTrials.govInquiries@pfizer.com
Trial locations and contacts
15 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
15 sites in 2 countries
United States14 sites, 14 recruiting
- Not yet recruiting
Charlottesville Medical Research Center, LLC
Charlottesville, Virginia, 22911
- Not yet recruiting
Remington-Davis, Inc
Columbus, Ohio, 43215
- Not yet recruiting
J. Lewis Research, Inc. / Foothill Family Clinic Draper
Draper, Utah, 84020
- Not yet recruiting
MediSphere Medical Research Center, LLC
Evansville, Indiana, 47714
- Not yet recruiting
Orange County Research Center
Lake Forest, California, 92630
- Not yet recruiting
Solaris Clinical Research
Meridian, Idaho, 83646
- Not yet recruiting
Clinical Research Consulting, LLC
Milford, Connecticut, 06460
- Not yet recruiting
DM Clinical Research - Philadelphia
Philadelphia, Pennsylvania, 19107
- Not yet recruiting
Clinical Research Partners, LLC
Richmond, Virginia, 23226
- Not yet recruiting
Artemis Institute for Clinical Research
Riverside, California, 92503
- Not yet recruiting
Headlands Research - Scottsdale
Scottsdale, Arizona, 85260
- Not yet recruiting
J. Lewis Research, Inc. / Jordan River Family Medicine
South Jordan, Utah, 84095
- Not yet recruiting
IMA Clinical Research Warren
Warren Township, New Jersey, 07059
- Not yet recruiting
George Washington University
Washington D.C., District of Columbia, 20037
China1 site, 1 recruiting
- Recruiting
Huashan Hospital Fudan University
Shanghai, Shanghai Municipality, 200040
About this study
Official title: AN INTERVENTIONAL PHASE 3 STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF A RESPIRATORY SYNCYTIAL VIRUS (RSV) PREFUSION F SUBUNIT VACCINE IN PARTICIPANTS 60 YEARS OF AGE AND OLDER
The purpose of this study is to learn about the safety, tolerability, and immune response of the RSVpreF vaccine in healthy older adults.
Participants will take part in this study for about 6 months.
Read more
The study will include people in China and the United States. In China, participants will receive either RSVpreF or placebo. A placebo is a dummy vaccine with no active ingredient, but it looks just like the vaccine being studied. In the United States, all participants will receive RSVpreF.
Researchers will check for any reactions. They will also check blood test results to learn how the body responds to the vaccine.
The main questions the study aims to answer are:
- What local reactions and systemic events (body-wide symptoms) do participants have after a RSVpreF vaccination?
- What medical problems do participants have after a RSVpreF vaccination?
- Researchers will compare antibody levels from blood tests between the China cohort and the US cohort. An antibody is a substance in the body that try to fight off an infection or foreign substance.
Participants will:
- Have a screening visit to make sure they qualify for the study (participants in China will have this visit before the day of vaccination)
- Receive the RSVpreF vaccination (or a placebo injection if in the China cohort) once at Visit 1.
- Have a telephone or clinic visit 1 week later to assess local reactions and systemic events.
- Have a clinic visit a month after vaccination for a checkup and tests.
- Have a telephone or clinic visit 6 months after vaccination for a health check.
- Have a blood test at screening (if in the China cohort only), on the day of vaccination and 1 month after vaccination.
- Conditions
- Adult, Healthy Participants
- Being tested
- RSVpreF, Placebo
- Keywords
- RSV vaccine, Respiratory Syncytial Virus (RSV)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RSVpreFBiological
Single Dose
PlaceboOther
Single Dose
| Study group | Role | What they receive |
|---|---|---|
| China Placebo | Placebo comparator | Single dose, Placebo vaccine Receives: Other: Placebo |
| China RSVpreF | Active comparator | Single dose, RSVpreF vaccine Receives: Biological: RSVpreF |
| US RSVpreF | Active comparator | Single dose, RSVpreF vaccine Receives: Biological: RSVpreF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of participants reporting local reactions: pain at the injection site, redness, and swelling
Measured: Within 7 days after vaccination
Percentage of participants reporting systemic events: fever, fatigue, headache, vomiting, nausea, diarrhea, muscle pain, and joint pain
Measured: Within 7 days after vaccination
Percentage of participants reporting adverse events (AEs)
Measured: Within 1 month after vaccination
Percentage of participants reporting serious adverse events (SAEs)
Measured: Through 6 months after vaccination
Percentage of participants reporting newly diagnosed chronic medical conditions (NDCMCs)
Measured: Through 6 months after vaccination
RSV A and RSV B neutralizing antibody levels before vaccination and 1 month after vaccination
Measured: Before vaccination and 1 month after vaccination
Geometric mean fold rise in RSV A and RSV B neutralizing antibody levels from before vaccination to 1 month after vaccination
Measured: Before vaccination to 1 month after vaccination
Secondary outcomes (1)
Seroresponse rate for RSV A and RSV B neutralizing antibody levels
Measured: 1 month after vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2026
- Study start9 Sep 2026
- Primary completion16 May 2027 (estimated)
- Study completion16 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AdultStudies of the same condition, open and under way.
- More trials run by PfizerThe 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Phase 3, interventional, parallel assignment
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07819097
- Sponsor's protocol ID
- C3671091
- Status last verified
- Oct 2026
- First submitted
- 8 Sep 2026
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AN INTERVENTIONAL PHASE 3 STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF A RESPIRATORY SYNCYTIAL VIRUS (RSV) PREFUSION F SUBUNIT VACCINE IN PARTICIPANTS 60 YEARS OF AGE AND OLDER
- ClinicalTrials.gov ID
- NCT07819097
- Acronym / sponsor ID
- C3671091
- Conditions
- Adult, Healthy Participants
- Keywords
- RSV vaccine, Respiratory Syncytial Virus (RSV)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 9 Sep 2026 (actual)
- Primary completion
- 16 May 2027 (estimated)
- Study completion
- 16 May 2027 (estimated)
- First posted
- 14 Sep 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, tolerability, and immune response of the RSVpreF vaccine in healthy older adults.
Participants will take part in this study for about 6 months.
The study will include people in China and the United States. In China, participants will receive either RSVpreF or placebo. A placebo is a dummy vaccine with no active ingredient, but it looks just like the vaccine being studied. In the United States, all participants will receive RSVpreF.
Researchers will check for any reactions. They will also check blood test results to learn how the body responds to the vaccine.
The main questions the study aims to answer are:
- What local reactions and systemic events (body-wide symptoms) do participants have after a RSVpreF vaccination?
- What medical problems do participants have after a RSVpreF vaccination?
- Researchers will compare antibody levels from blood tests between the China cohort and the US cohort. An antibody is a substance in the body that try to fight off an infection or foreign substance.
Participants will:
- Have a screening visit to make sure they qualify for the study (participants in China will have this visit before the day of vaccination)
- Receive the RSVpreF vaccination (or a placebo injection if in the China cohort) once at Visit 1.
- Have a telephone or clinic visit 1 week later to assess local reactions and systemic events.
- Have a clinic visit a month after vaccination for a checkup and tests.
- Have a telephone or clinic visit 6 months after vaccination for a health check.
- Have a blood test at screening (if in the China cohort only), on the day of vaccination and 1 month after vaccination.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Phase 3, interventional, parallel assignment
| Arm | Type | Receives |
|---|---|---|
| China Placebo | Placebo comparator | Other: PlaceboSingle dose, Placebo vaccine |
| China RSVpreF | Active comparator | Biological: RSVpreFSingle dose, RSVpreF vaccine |
| US RSVpreF | Active comparator | Biological: RSVpreFSingle dose, RSVpreF vaccine |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Participants 60 years of age or older at enrolment.
- Healthy participants, or participants with stable long-term medical conditions, if the investigator decides they can take part.
- Adults who can walk and live in the community or in assisted-living/long-term care settings with minimal help.
- Participants who can give signed informed consent and follow study visits and procedures, including the 7-day electronic diary and blood tests.
Key exclusion criteria (7 listed)
- Confirmed RSV infection 180 days or less before study vaccination.
- Any past history of Guillain-Barré syndrome.
- Severe reaction to a vaccine or severe allergy to a study vaccine component or related vaccine.
- Serious or unstable medical condition that the investigator believes makes the study unsafe.
- Immunocompromised status, based on medical history and/or examination.
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 |
|---|---|---|
| RSVpreFSingle Dose | Biological | China RSVpreF, US RSVpreF |
| PlaceboSingle Dose | Other | China Placebo |
Primary outcome
Percentage of participants reporting local reactions: pain at the injection site, redness, and swelling
Time frame: Within 7 days after vaccination
Percentage of participants reporting systemic events: fever, fatigue, headache, vomiting, nausea, diarrhea, muscle pain, and joint pain
Time frame: Within 7 days after vaccination
Percentage of participants reporting adverse events (AEs)
Time frame: Within 1 month after vaccination
Percentage of participants reporting serious adverse events (SAEs)
Time frame: Through 6 months after vaccination
Percentage of participants reporting newly diagnosed chronic medical conditions (NDCMCs)
Time frame: Through 6 months after vaccination
RSV A and RSV B neutralizing antibody levels before vaccination and 1 month after vaccination
Time frame: Before vaccination and 1 month after vaccination
Geometric mean fold rise in RSV A and RSV B neutralizing antibody levels from before vaccination to 1 month after vaccination
Time frame: Before vaccination to 1 month after vaccination
1 secondary outcome
Seroresponse rate for RSV A and RSV B neutralizing antibody levels
Time frame: 1 month 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 9 Oct 2026.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
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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
15 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing RSVpreF in people with Adult and Healthy Participants, run by Pfizer at 15 sites in 2 countries.
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 4 inclusion and 7 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 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United States, China. 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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: pain at the injection site, redness, and swelling (time frame: Within 7 days after vaccination). The study lists 7 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 9 Oct 2026.