A Study to Evaluate the Safety and Immunogenicity of RSVpreF Coadministered With Herpes Zoster Vaccine in Adults
PISSARRO
A 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
2 other identifiers
interventional
526
2 countries
26
Brief Summary
This purpose of this phase 3 multicenter, parallel-group, open-label study is to learn about the safety, tolerability, and immunogenicity of RSVpreF and HZ/su vaccine when given together in adults 50 years of age and older.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Apr 2025
Shorter than P25 for phase_3
26 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 17, 2025
CompletedFirst Posted
Study publicly available on registry
March 24, 2025
CompletedStudy Start
First participant enrolled
April 4, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2025
CompletedNovember 6, 2025
November 1, 2025
6 months
March 17, 2025
November 5, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (6)
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
1 month after vaccination with RSVpreF in the RSVpreF + HZ/su coadministration group to RSVpreF alone in the sequential administration group
Anti-gE antibody concentrations expressed as Geometric Mean Concentration (GMC) ratios in RSVpreF + HZ/su Compared to HZ/su Alone
1 month after the second dose of HZ/su in the RSVpreF + HZ/su coadministration group to HZ/su alone in the sequential administration group
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).
Within 7 Days after each vaccination (Vaccination on Day 1)
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).
Within 7 Days after each vaccination (Vaccination on Day 1)
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
Within 1 Month after last vaccination
Percentage of Participants with Serious Adverse Events (SAEs) Throughout the Study
Describe SAEs occurring through 4 months after the first study intervention administration.
Within 4 Months after first study vaccination (Vaccination on Day 1)
Secondary Outcomes (6)
NTs for RSV A and RSV B expressed as Geometric Mean Titers (GMT)
Before vaccination with RSVpreF, 1 month after vaccination with RSVpreF
NTs for RSV A and RSV B expressed as Geometric Mean Fold Rise (GMFR)
Before vaccination and 1 month after vaccination with RSVpreF
NTs for RSV A and RSV B expressed as seroresponse rate
1 month after vaccination with RSVpreF
Anti-gE antibody concentrations expressed as GMCs
Before vaccination and 1 month after the second dose of HZ/su
Anti-gE antibody concentrations expressed as GMFRs
Before vaccination and 1 month after the second dose of HZ/su
- +1 more secondary outcomes
Study Arms (2)
Coadministration Group
OTHER* Visit 1 (Day 1): RSVpreF + HZ/su dose 1 * Visit 3 (Month 2): HZ/su dose 2
Sequential Administration Group
OTHER* Visit 1 (Day 1): HZ/su dose 1 * Visit 2 (Month 1): RSVpreF * Visit 3 (Month 2): HZ/su dose 2
Interventions
Intramuscular injection
intramuscular injection
Eligibility Criteria
You may qualify if:
- Male and female participants 50 years of age and older who are healthy or with stable chronic medical conditions
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (26)
Central Research Associates
Birmingham, Alabama, 35205, United States
Medical Affiliated Research Center
Huntsville, Alabama, 35801, United States
AMR Clinical
Mobile, Alabama, 36608, United States
Kaiser Permanente
Los Angeles, California, 90027, United States
Diablo Clinical Research, Inc.
Walnut Creek, California, 94598, United States
Alliance for Multispecialty Research, LLC
Doral, Florida, 33172, United States
Proactive Clinical Research,LLC
Fort Lauderdale, Florida, 33308, United States
De La Cruz Research Center, LLC
Miami, Florida, 33184, United States
Centricity Research Columbus Georgia Multispecialty
Columbus, Georgia, 31904, United States
Clinical Research Atlanta
Stockbridge, Georgia, 30281, United States
Synexus Clinical Research US, Inc.
Chicago, Illinois, 60602, United States
Optimal Research
Peoria, Illinois, 61614, United States
DelRicht Research
New Orleans, Louisiana, 70115, United States
Jadestone Clinical Research
Silver Spring, Maryland, 20904, United States
Oakland Medical Research
Troy, Michigan, 48085, United States
Clinical Research Professionals
Chesterfield, Missouri, 63005, United States
IMA Clinical Research Warren
Warren Township, New Jersey, 07059, United States
NYU Langone Health
New York, New York, 10016, United States
Centricity Research Columbus Ohio Multispecialty
Columbus, Ohio, 43213, United States
DM Clinical Research - Philadelphia
Philadelphia, Pennsylvania, 19107, United States
Clinical Neuroscience Solutions Inc.
Memphis, Tennessee, 38119, United States
DM Clinical Research - Bellaire
Houston, Texas, 77081, United States
SMS Clinical Research
Mesquite, Texas, 75149, United States
IMA Clinical Research San Antonio
San Antonio, Texas, 78229, United States
DM Clinical Research - Sugar Land
Sugar Land, Texas, 77478, United States
Clinical Research Puerto Rico
San Juan, 00909, Puerto Rico
Related Links
MeSH Terms
Interventions
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
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
March 17, 2025
First Posted
March 24, 2025
Study Start
April 4, 2025
Primary Completion
September 30, 2025
Study Completion
September 30, 2025
Last Updated
November 6, 2025
Record last verified: 2025-11
Data Sharing
- IPD Sharing
- Will share
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.