A Study to Evaluate the Safety and Immunogenicity of RSVpreF Coadministered With Herpes Zoster Vaccine in Adults (PISSARRO)
November 5, 2025 updated by: Pfizer
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
526
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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San Juan, Puerto Rico, 00909
- Clinical Research Puerto Rico
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Alabama
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Birmingham, Alabama, United States, 35205
- Central Research Associates
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Huntsville, Alabama, United States, 35801
- Medical Affiliated Research Center
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Mobile, Alabama, United States, 36608
- AMR Clinical
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California
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Los Angeles, California, United States, 90027
- Kaiser Permanente
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Walnut Creek, California, United States, 94598
- Diablo Clinical Research, Inc.
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Florida
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Doral, Florida, United States, 33172
- Alliance for Multispecialty Research, LLC
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Fort Lauderdale, Florida, United States, 33308
- Proactive Clinical Research,LLC
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Miami, Florida, United States, 33184
- De La Cruz Research Center, LLC
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Georgia
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Columbus, Georgia, United States, 31904
- Centricity Research Columbus Georgia Multispecialty
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Stockbridge, Georgia, United States, 30281
- Clinical Research Atlanta
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Illinois
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Chicago, Illinois, United States, 60602
- Synexus Clinical Research US, Inc.
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Peoria, Illinois, United States, 61614
- Optimal Research
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Louisiana
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New Orleans, Louisiana, United States, 70115
- DelRicht Research
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Maryland
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Silver Spring, Maryland, United States, 20904
- Jadestone Clinical Research
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Michigan
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Troy, Michigan, United States, 48085
- Oakland Medical Research
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Missouri
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Chesterfield, Missouri, United States, 63005
- Clinical Research Professionals
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New Jersey
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Warren Township, New Jersey, United States, 07059
- IMA Clinical Research Warren
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New York
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New York, New York, United States, 10016
- NYU Langone Health
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Ohio
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Columbus, Ohio, United States, 43213
- Centricity Research Columbus Ohio Multispecialty
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19107
- DM Clinical Research - Philadelphia
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Tennessee
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Memphis, Tennessee, United States, 38119
- Clinical Neuroscience Solutions Inc.
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Texas
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Houston, Texas, United States, 77081
- DM Clinical Research - Bellaire
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Mesquite, Texas, United States, 75149
- SMS Clinical Research
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San Antonio, Texas, United States, 78229
- IMA Clinical Research San Antonio
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Sugar Land, Texas, United States, 77478
- DM Clinical Research - Sugar Land
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Other: Coadministration Group
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Intramuscular injection
Other Names:
intramuscular injection
Other Names:
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Other: Sequential Administration Group
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Intramuscular injection
Other Names:
intramuscular injection
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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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
Time Frame: 1 month after vaccination with RSVpreF in the RSVpreF + HZ/su coadministration group to RSVpreF alone in the sequential administration group
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1 month after vaccination with RSVpreF in the RSVpreF + HZ/su coadministration group to RSVpreF alone in the sequential administration group
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Anti-gE antibody concentrations expressed as Geometric Mean Concentration (GMC) ratios in RSVpreF + HZ/su Compared to HZ/su Alone
Time Frame: 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
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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
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Percentage of Participants reporting Local Reactions Within 7 Days after Vaccination
Time Frame: Within 7 Days after each vaccination (Vaccination on Day 1)
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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).
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Within 7 Days after each vaccination (Vaccination on Day 1)
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Percentage of Participants with Systemic Events Within 7 Days after Vaccination
Time Frame: Within 7 Days after each vaccination (Vaccination on Day 1)
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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).
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Within 7 Days after each vaccination (Vaccination on Day 1)
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Percentage of Participants with Adverse Events (AEs)from Vaccination through 1 Month after Vaccination
Time Frame: Within 1 Month after last vaccination
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Describe AEs occurring through 1 month after each study intervention administration
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Within 1 Month after last vaccination
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Percentage of Participants with Serious Adverse Events (SAEs) Throughout the Study
Time Frame: Within 4 Months after first study vaccination (Vaccination on Day 1)
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Describe SAEs occurring through 4 months after the first study intervention administration.
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Within 4 Months after first study vaccination (Vaccination on Day 1)
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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NTs for RSV A and RSV B expressed as Geometric Mean Titers (GMT)
Time Frame: Before vaccination with RSVpreF, 1 month after vaccination with RSVpreF
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Before vaccination with RSVpreF, 1 month after vaccination with RSVpreF
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NTs for RSV A and RSV B expressed as Geometric Mean Fold Rise (GMFR)
Time Frame: Before vaccination and 1 month after vaccination with RSVpreF
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Before vaccination and 1 month after vaccination with RSVpreF
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NTs for RSV A and RSV B expressed as seroresponse rate
Time Frame: 1 month after vaccination with RSVpreF
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1 month after vaccination with RSVpreF
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Anti-gE antibody concentrations expressed as GMCs
Time Frame: Before vaccination and 1 month after the second dose of HZ/su
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Before vaccination and 1 month after the second dose of HZ/su
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Anti-gE antibody concentrations expressed as GMFRs
Time Frame: Before vaccination and 1 month after the second dose of HZ/su
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Before vaccination and 1 month after the second dose of HZ/su
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Anti-gE antibody concentrations expressed as seroresponse rate
Time Frame: 1 month after the second dose of HZ/su
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1 month after the second dose of HZ/su
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Pfizer CT.gov Call Center, Pfizer
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 4, 2025
Primary Completion (Actual)
September 30, 2025
Study Completion (Actual)
September 30, 2025
Study Registration Dates
First Submitted
March 17, 2025
First Submitted That Met QC Criteria
March 17, 2025
First Posted (Actual)
March 24, 2025
Study Record Updates
Last Update Posted (Estimated)
November 6, 2025
Last Update Submitted That Met QC Criteria
November 5, 2025
Last Verified
November 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- C3671058
- PISSARRO (Other Identifier: Alias Study Number)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
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.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
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