NCT07768345 A Study to Learn About Revaccination With a Vaccine Called RSVpreF in Immunocompromised Adults
| NCT ID | NCT07768345 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Pfizer |
| Condition | Respiratory Syncytial Virus (RSV) |
| Study Type | INTERVENTIONAL |
| Enrollment | 440 participants |
| Start Date | 2026-08-31 |
| Primary Completion | 2028-02-02 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 440 participants in total. It began in 2026-08-31 with a primary completion date of 2028-02-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The purpose of this phase 3 study is to learn the safety, tolerability and immunogenicity of revaccination with RSVpreF at approximately 1-, 2-, and 3-year intervals to inform the revaccination interval in immunocompromised adults. This study is seeking participants who are 18 years of age and older and will be grouped based on prior RSV vaccination history. Participants are required to be immunocompromised per study protocol. All participants in this study will receive 1 shot to their arm of a RSVPreF vaccine. Participants will take part in this study for about 12 months and will need to visit the clinical study site at least 4 times.
Eligibility Criteria
Key Inclusion Criteria: * Participants ≥18 years of age who are/were immunocompromised at the time of initial RSVpreF vaccination, per study protocol, and will be grouped based on prior RSV vaccination history: * Group 1 will include participants naïve to any RSV vaccine. * Group 2 will include participants who received a single prior dose of RSVpreF (Abrysvo) approximately 1 year (9 to 15 months) prior to enrollment. * Group 3 will include participants who received a single prior dose of RSVpreF (Abrysvo) approximately 2 years (21 to 27 months) prior to enrollment. * Group 4 will include participants who previously received 2 doses of RSVpreF in Study C3671023 Substudy B approximately 3 years (36 to 42 months) prior to enrollment. * Participants should have a life expectancy ≥12 months (365 days) in the opinion of the investigator at enrollment. Key Exclusion Criteria: * Prior history of any subtype of Guillain-Barré Syndrome (GBS) of any etiology. * History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any components of the study intervention(s). * Participants with a history of transplant rejection, or PTLD, or participants who have had treatment for these conditions, within 90 days prior to study enrollment or suspected chronic humoral or cellular rejection. * Receipt of B-cell depleting therapies within 180 days prior to initial study vaccination. Refer to the study contact for further eligibility details.
Contact & Investigator
Pfizer CT.gov Call Center
STUDY DIRECTOR
Pfizer
Frequently Asked Questions
Who can join the NCT07768345 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Respiratory Syncytial Virus (RSV). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07768345 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 440 participants.
Is NCT07768345 currently recruiting?
Yes, NCT07768345 is actively recruiting participants. Contact the research team at ClinicalTrials.gov_Inquiries@pfizer.com for enrollment information.
Where is the NCT07768345 trial being conducted?
This trial is being conducted at Los Angeles, United States, Los Angeles, United States, Los Angeles, United States, Washington D.C., United States and 11 additional locations.
Who is sponsoring the NCT07768345 clinical trial?
NCT07768345 is sponsored by Pfizer. The principal investigator is Pfizer CT.gov Call Center at Pfizer. The trial plans to enroll 440 participants.