A Study to Learn About Revaccination With a Vaccine Called RSVpreF in Older Adults

NCT07885956 | Not Yet Recruiting Phase 3 FDA Drug

• 2 other identifiers: C3671087CEZANNE
• Study Type: interventional
• Target: 750
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Respiratory Syncytial Virus (RSV)

Outcome Measures

Primary Outcomes (5)

• Percentage of participants reporting local reactions

  For up to 7 days after vaccination

• Percentage of participants reporting systemic events

  For up to 7 days after vaccination

• Percentage of participants reporting adverse events

  Through 1 month after vaccination

• Percentage of participants reporting newly diagnosed chronic medical conditions

  Through 18 months after vaccination

• Percentage of participants reporting serious adverse events

  Through 18 months after vaccination

Study Arms (3)

Group 1

EXPERIMENTAL

Participants will receive a single open-label, intramuscular injection of RSVpreF (Regimen A) as a revaccination.

Biological: RSVpreF (Regimen A)

Group 2

EXPERIMENTAL

Participants will receive a single open-label, intramuscular injection of RSVpreF (Regimen B) as a revaccination.

Biological: RSVpreF (Regimen B)

Group 3

NO INTERVENTION

Participants will not be revaccinated.

Interventions

RSVpreF (Regimen B) BIOLOGICAL

Regimen B

Group 2

RSVpreF (Regimen A) BIOLOGICAL

Regimen A

Group 1

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Interventions

Regimen B

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Central Study Contacts

Pfizer CT.gov Call Center

CONTACT

1-800-718-1021; ClinicalTrials.gov_Inquiries@pfizer.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 14, 2026
• First Posted: October 21, 2026
• Study Start (Estimated): October 29, 2026
• Primary Completion (Estimated): February 7, 2029
• Study Completion (Estimated): February 7, 2029
• Last Updated: October 21, 2026

Record last verified: 2026-10

Data Sharing

• IPD Sharing: Will share