Respiratory Syncytial Virus (RSV)Phase 3NCT07885956
A Study to Learn About Revaccination With a Vaccine Called RSVpreF in Older Adults
A Phase 3 study testing RSVpreF (Regimen A) and RSVpreF (Regimen B) in people with Respiratory Syncytial Virus (RSV), run by Pfizer.
Trial summary
This study is testing the safety and tolerability of a second dose of Respiratory Syncytial Virus Vaccine (RSVpreF) given approximately 5 years after the initial dose. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Respiratory Syncytial Virus (RSV)
- What is being tested?
- RSVpreF (Regimen A) and RSVpreF (Regimen B)
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 750 participants
- Where
- No sites listed yet
- Study dates
- 29 Oct 2026to 7 Feb 2029
- 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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Must have participated in the previous Pfizer RSVpreF efficacy study (C3671013) and have been ≥60 years of age at the time of their enrollment in that study.
- Must have received their initial RSVpreF dose in the C3671013 study about 5 years prior to enrollment in the current study (C3671087).
- Must be determined to be in good health by the investigator, based on medical history and clinical judgment. Participants with stable chronic diseases (e.g., disease not requiring significant change in therapy or hospitalization for worsening disease during the 6 weeks before enrollment) are eligible.
Who cannot join
- History of a severe allergic reaction (e.g., anaphylaxis) to any component of the study intervention or any related vaccine.
- History of Guillain-Barré Syndrome of any subtype or etiology.
- Certain serious or unstable medical conditions that could increase the risks of study participation.
- Previous vaccination with any other investigational or licensed RSV vaccine since receiving the initial dose in the C3671013 study.
- Any medical or psychiatric condition that, in the investigator's judgment, would make the participant inappropriate for the study.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A PHASE 3, RANDOMIZED, OPEN-LABEL STUDY TO EVALUATE THE SAFETY AND TOLERABILITY OF A SECOND DOSE OF RESPIRATORY SYNCYTIAL VIRUS (RSV) PREFUSION F SUBUNIT VACCINE GIVEN 5 YEARS AFTER THE INITIAL DOSE IN OLDER ADULTS
This study is testing the safety and tolerability of a second dose of Respiratory Syncytial Virus Vaccine (RSVpreF) given approximately 5 years after the initial dose.
Read the detailed description
Respiratory syncytial virus (RSV) can cause serious respiratory illness in older adults. Previous studies showed that RSVpreF helped protect adults from RSV disease. This study will evaluate the safety of receiving another RSVpreF vaccination about 5 years after an earlier RSVpreF dose.
Participants who previously received RSVpreF in Study C3671013 will be assigned to one of three groups:
- receive a dose RSVpreF revaccination,
- receive a dose RSVpreF revaccination, or
- not receive revaccination and continue follow-up.
Researchers will evaluate side effects after vaccination and collect blood samples over approximately 18 months.
- Conditions
- Respiratory Syncytial Virus (RSV)
- Being tested
- RSVpreF (Regimen A), RSVpreF (Regimen B)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RSVpreF (Regimen A)Biological
Regimen A
RSVpreF (Regimen B)Biological
Regimen B
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Participants will receive a single open-label, intramuscular injection of RSVpreF (Regimen A) as a revaccination. Receives: Biological: RSVpreF (Regimen A) |
| Group 2 | Experimental | Participants will receive a single open-label, intramuscular injection of RSVpreF (Regimen B) as a revaccination. Receives: Biological: RSVpreF (Regimen B) |
| Group 3 | No intervention | Participants will not be revaccinated. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of participants reporting local reactions
Measured: For up to 7 days after vaccination
Percentage of participants reporting systemic events
Measured: For up to 7 days after vaccination
Percentage of participants reporting adverse events
Measured: Through 1 month after vaccination
Percentage of participants reporting newly diagnosed chronic medical conditions
Measured: Through 18 months after vaccination
Percentage of participants reporting serious adverse events
Measured: Through 18 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 posted21 Oct 2026
- Study start29 Oct 2026 (estimated)
- Primary completion7 Feb 2029 (estimated)
- Study completion7 Feb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Syncytial Virus (RSV)Studies 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
- Masking
- None (open label)
- Enrolment
- 750 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
- NCT07885956
- Sponsor's protocol ID
- C3671087
- Other IDs
- CEZANNE
- Status last verified
- Oct 2026
- First submitted
- 14 Oct 2026
- Last updated
- 21 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 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A PHASE 3, RANDOMIZED, OPEN-LABEL STUDY TO EVALUATE THE SAFETY AND TOLERABILITY OF A SECOND DOSE OF RESPIRATORY SYNCYTIAL VIRUS (RSV) PREFUSION F SUBUNIT VACCINE GIVEN 5 YEARS AFTER THE INITIAL DOSE IN OLDER ADULTS
- ClinicalTrials.gov ID
- NCT07885956
- Acronym / sponsor ID
- C3671087
- Conditions
- Respiratory Syncytial Virus (RSV)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 750 participants (estimated)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 29 Oct 2026 (estimated)
- Primary completion
- 7 Feb 2029 (estimated)
- Study completion
- 7 Feb 2029 (estimated)
- First posted
- 21 Oct 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.
This study is testing the safety and tolerability of a second dose of Respiratory Syncytial Virus Vaccine (RSVpreF) given approximately 5 years after the initial dose.
Detailed description
Respiratory syncytial virus (RSV) can cause serious respiratory illness in older adults. Previous studies showed that RSVpreF helped protect adults from RSV disease. This study will evaluate the safety of receiving another RSVpreF vaccination about 5 years after an earlier RSVpreF dose.
Participants who previously received RSVpreF in Study C3671013 will be assigned to one of three groups:
- receive a dose RSVpreF revaccination,
- receive a dose RSVpreF revaccination, or
- not receive revaccination and continue follow-up.
Researchers will evaluate side effects after vaccination and collect blood samples over approximately 18 months.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Biological: RSVpreF (Regimen A)Participants will receive a single open-label, intramuscular injection of RSVpreF (Regimen A) as a revaccination. |
| Group 2 | Experimental | Biological: RSVpreF (Regimen B)Participants will receive a single open-label, intramuscular injection of RSVpreF (Regimen B) as a revaccination. |
| Group 3 | No intervention | –Participants will not be revaccinated. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Must have participated in the previous Pfizer RSVpreF efficacy study (C3671013) and have been ≥60 years of age at the time of their enrollment in that study.
- Must have received their initial RSVpreF dose in the C3671013 study about 5 years prior to enrollment in the current study (C3671087).
- Must be determined to be in good health by the investigator, based on medical history and clinical judgment. Participants with stable chronic diseases (e.g., disease not requiring significant change in therapy or hospitalization for worsening disease during the 6 weeks before enrollment) are eligible.
Key exclusion criteria (5 listed)
- History of a severe allergic reaction (e.g., anaphylaxis) to any component of the study intervention or any related vaccine.
- History of Guillain-Barré Syndrome of any subtype or etiology.
- Certain serious or unstable medical conditions that could increase the risks of study participation.
- Previous vaccination with any other investigational or licensed RSV vaccine since receiving the initial dose in the C3671013 study.
- Any medical or psychiatric condition that, in the investigator's judgment, would make the participant inappropriate for the study.
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 |
|---|---|---|
| RSVpreF (Regimen A)Regimen A | Biological | Group 1 |
| RSVpreF (Regimen B)Regimen B | Biological | Group 2 |
Primary outcome
Percentage of participants reporting local reactions
Time frame: For up to 7 days after vaccination
Percentage of participants reporting systemic events
Time frame: For up to 7 days after vaccination
Percentage of participants reporting adverse events
Time frame: Through 1 month after vaccination
Percentage of participants reporting newly diagnosed chronic medical conditions
Time frame: Through 18 months after vaccination
Percentage of participants reporting serious adverse events
Time frame: Through 18 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 21 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
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing RSVpreF (Regimen A) and RSVpreF (Regimen B) in people with Respiratory Syncytial Virus (RSV), run by Pfizer.
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 3 inclusion and 5 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: opening soon, as of the sponsor's last update on 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
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 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 (time frame: For up to 7 days after vaccination). The study lists 5 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 21 Oct 2026.