A Study to Evaluate the Safety and Immunogenicity of RSVpreF Coadministered With Herpes Zoster Vaccine in Adults

Recruitment Status
COMPLETED
(See Contacts and Locations)Verified October 2025 by Pfizer
Sponsor
Pfizer
Information Provided by (Responsible Party)
Pfizer
Clinicaltrials.gov Identifier
NCT06890416
Other Study ID Numbers:
C3671058
First Submitted
March 16, 2025
First Posted
March 23, 2025
Last Update Posted
November 5, 2025
Last Verified
October 2025

ClinicalTrials.gov processed this data on November 2025. Link to the current ClinicalTrials.gov record .

History of Changes

Study Details

Study Description

Condition or DiseaseIntervention/Treatment
Respiratory Syncytial Virus (RSV)
Biological: RESPIRATORY SYNCYTIAL VIRUS PREFUSION F SUBUNIT VACCINEBiological: RESPIRATORY SYNCYTIAL VIRUS PREFUSION F SUBUNIT VACCINE

Study Design

Study TypeInterventional
Actual Enrollment526 participants
Design AllocationRandomized
Interventional ModelParallel Assignment
MaskingNone (Open Label)
Primary PurposePrevention
Official TitleA PHASE 3, MULTICENTER, PARALLEL-GROUP, OPEN-LABEL STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF RESPIRATORY SYNCYTIAL VIRUS PREFUSION F SUBUNIT VACCINE WHEN COADMINISTERED WITH HERPES ZOSTER SUBUNIT VACCINE IN ADULTS ≥50 YEARS OF AGE
Study Start DateApril 3, 2025
Actual Primary Completion DateSeptember 29, 2025
Actual Study Completion DateSeptember 29, 2025

Groups and Cohorts

Group/CohortIntervention/Treatment
Coadministration Group
* Visit 1 (Day 1): RSVpreF + HZ/su dose 1 * Visit 3 (Month 2): HZ/su dose 2
Biological: RESPIRATORY SYNCYTIAL VIRUS PREFUSION F SUBUNIT VACCINE
Intramuscular injection
Sequential Administration Group
* Visit 1 (Day 1): HZ/su dose 1 * Visit 2 (Month 1): RSVpreF * Visit 3 (Month 2): HZ/su dose 2
Biological: RESPIRATORY SYNCYTIAL VIRUS PREFUSION F SUBUNIT VACCINE
Intramuscular injection

Outcome Measures

Primary Outcome Measures
  1. Geometric Mean Ratio (GMR) of Neutralizing Titer (NTs) for RSV A and B in RSVpreF + herpes zoster subunit vaccine (HZ/su) Compared to RSVpreF Alone
  2. Anti-gE antibody concentrations expressed as Geometric Mean Concentration (GMC) ratios in RSVpreF + HZ/su Compared to HZ/su Alone
  3. Percentage of Participants reporting Local Reactions Within 7 Days after Vaccination
    Describe local reactions (redness, swelling, and pain at the injection site) within 7 days following each study intervention administration recorded by participants in an electronic diary (e-diary).
  4. Percentage of Participants with Systemic Events Within 7 Days after Vaccination
    Describe systemic events (fatigue, headache, vomiting, nausea, diarrhea, muscle pain, and joint pain) within 7 days following each study intervention administration recorded by participants in an electronic diary (e-diary).
  5. Percentage of Participants with Adverse Events (AEs)from Vaccination through 1 Month after Vaccination
    Describe AEs occurring through 1 month after each study intervention administration
  6. Percentage of Participants with Serious Adverse Events (SAEs) Throughout the Study
    Describe SAEs occurring through 4 months after the first study intervention administration.
Secondary Outcome Measures
  1. NTs for RSV A and RSV B expressed as Geometric Mean Titers (GMT)
  2. NTs for RSV A and RSV B expressed as Geometric Mean Fold Rise (GMFR)
  3. NTs for RSV A and RSV B expressed as seroresponse rate
  4. Anti-gE antibody concentrations expressed as GMCs
  5. Anti-gE antibody concentrations expressed as GMFRs
  6. Anti-gE antibody concentrations expressed as seroresponse rate

Eligibility Criteria

Ages Eligible for Study(Adult, Older Adult)
Sexes Eligible for StudyAll
Accepts Healthy VolunteersYes
Inclusion Criteria
Inclusion Criteria • Male and female participants 50 years of age and older who are healthy or with stable chronic medical conditions
Exclusion Criteria
Inclusion Criteria • Male and female participants 50 years of age and older who are healthy or with stable chronic medical conditions Exclusion Criteria
Current clinically suspected or polymerase chain reaction (PCR)-confirmed ongoing episode of HZ and/or history of clinically suspected or PCR-confirmed HZ within the past 12 months.
Prior history of any subtype of Guillain Barré syndrome of any etiology.
Serious chronic disorder, including metastatic malignancy, end-stage renal disease with or without dialysis, clinically unstable cardiac disease, or any other disorder that, in the investigator's opinion, excludes the participant from participating in the study.
Immunocompromised individuals with known or suspected immunodeficiency, as determined by history and/or laboratory/physical examination, and medication list
Previous vaccination with any licensed or investigational RSV vaccine at any time prior to enrollment, or planned receipt of a nonstudy RSV vaccine during study participation.
Previous vaccination with any licensed recombinant adjuvant zoster vaccine (Shingrix) at any time prior to enrollment, or planned receipt of a nonstudy licensed VZV vaccine (Shingrix) during study participation.
History of previous vaccination with live HZ vaccine (Zostavax) in the last 2 years from enrollment, or planned receipt through study participation.
Previous vaccination with any investigational VZV vaccine at any time prior to enrollment, or planned receipt of a nonstudy investigational VZV vaccine during study participation.
Individuals who receive chronic systemic treatment with immunosuppressive therapy, including cytotoxic agents, immunosuppressive monoclonal antibodies, systemic corticosteroids (defined as ≥20 mg/day of prednisone or equivalent for ≥14 days), eg, for cancer or an autoimmune disease, or radiotherapy, from 60 days before study intervention administration, or planned receipt throughout the study.

Contacts and Locations

Sponsors and CollaboratorsPfizer
Locations
Central Research Associates | Birmingham Alabama, United States, 35205Medical Affiliated Research Center | Huntsville Alabama, United States, 35801AMR Clinical | Mobile Alabama, United States, 36608Kaiser Permanente | Los Angeles California, United States, 90027Diablo Clinical Research, Inc. | Walnut Creek California, United States, 94598Alliance for Multispecialty Research, LLC | Doral Florida, United States, 33172Proactive Clinical Research,LLC | Fort Lauderdale Florida, United States, 33308De La Cruz Research Center, LLC | Miami Florida, United States, 33184Centricity Research Columbus Georgia Multispecialty | Columbus Georgia, United States, 31904Clinical Research Atlanta | Stockbridge Georgia, United States, 30281Synexus Clinical Research US, Inc. | Chicago Illinois, United States, 60602Optimal Research | Peoria Illinois, United States, 61614DelRicht Research | New Orleans Louisiana, United States, 70115Jadestone Clinical Research | Silver Spring Maryland, United States, 20904Oakland Medical Research | Troy Michigan, United States, 48085Clinical Research Professionals | Chesterfield Missouri, United States, 63005IMA Clinical Research Warren | Warren Township New Jersey, United States, 07059NYU Langone Health | New York New York, United States, 10016Centricity Research Columbus Ohio Multispecialty | Columbus Ohio, United States, 43213DM Clinical Research - Philadelphia | Philadelphia Pennsylvania, United States, 19107Clinical Neuroscience Solutions Inc. | Memphis Tennessee, United States, 38119DM Clinical Research - Bellaire | Houston Texas, United States, 77081SMS Clinical Research | Mesquite Texas, United States, 75149IMA Clinical Research San Antonio | San Antonio Texas, United States, 78229DM Clinical Research - Sugar Land | Sugar Land Texas, United States, 77478Clinical Research Puerto Rico | San Juan , Puerto Rico, 00909
Investigators
Study Director: Pfizer CT.gov Call Center, Pfizer