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

Last updated: May 12, 2025
Sponsor: Pfizer
Overall Status: Active - Not Recruiting

Phase

3

Condition

Chickenpox (Varicella Zoster Infection)

Shingles

Rash

Treatment

RESPIRATORY SYNCYTIAL VIRUS PREFUSION F SUBUNIT VACCINE

HZ/su VACCINE

Clinical Study ID

NCT06890416
C3671058
PISSARRO
  • Ages > 50
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

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 Design

Total Participants: 525
Treatment Group(s): 2
Primary Treatment: RESPIRATORY SYNCYTIAL VIRUS PREFUSION F SUBUNIT VACCINE
Phase: 3
Study Start date:
April 04, 2025
Estimated Completion Date:
September 17, 2025

Connect with a study center

  • Clinical Research Puerto Rico

    San Juan, 00909
    Puerto Rico

    Site Not Available

  • Central Research Associates

    Birmingham, Alabama 35205
    United States

    Site Not Available

  • Medical Affiliated Research Center

    Huntsville, Alabama 35801
    United States

    Site Not Available

  • Alliance for Multispecialty Research, LLC

    Mobile, Alabama 36608
    United States

    Site Not Available

  • Kaiser Permanente

    Los Angeles, California 90027
    United States

    Site Not Available

  • Artemis Institute for Clinical Research

    San Diego, California 92103
    United States

    Site Not Available

  • Diablo Clinical Research, Inc.

    Walnut Creek, California 94598
    United States

    Site Not Available

  • Alliance for Multispecialty Research, LLC

    Coral Gables, Florida 33134
    United States

    Site Not Available

  • Proactive Clinical Research,LLC

    Fort Lauderdale, Florida 33308
    United States

    Site Not Available

  • De La Cruz Research Center, LLC

    Miami, Florida 33184
    United States

    Site Not Available

  • Centricity Research Columbus Georgia Multispecialty

    Columbus, Georgia 31904
    United States

    Site Not Available

  • Clinical Research Atlanta

    Stockbridge, Georgia 30281
    United States

    Site Not Available

  • Synexus Clinical Research US, Inc.

    Chicago, Illinois 60602
    United States

    Site Not Available

  • Optimal Research

    Peoria, Illinois 61614
    United States

    Site Not Available

  • DelRicht Research

    New Orleans, Louisiana 70115
    United States

    Site Not Available

  • Jadestone Clinical Research

    Silver Spring, Maryland 20904
    United States

    Site Not Available

  • Oakland Medical Research

    Troy, Michigan 48085
    United States

    Site Not Available

  • Clinical Research Professionals

    Chesterfield, Missouri 63005
    United States

    Site Not Available

  • IMA Clinical Research Warren

    Warren, New Jersey 07059
    United States

    Site Not Available

  • NYU Langone Health

    New York, New York 10016
    United States

    Site Not Available

  • Centricity Research Columbus Ohio Multispecialty

    Columbus, Ohio 43213
    United States

    Site Not Available

  • DM Clinical Research - Philadelphia

    Philadelphia, Pennsylvania 19107
    United States

    Site Not Available

  • Clinical Neuroscience Solutions Inc.

    Memphis, Tennessee 38119
    United States

    Site Not Available

  • DM Clinical Research - Bellaire

    Houston, Texas 77081
    United States

    Site Not Available

  • SMS Clinical Research

    Mesquite, Texas 75149
    United States

    Site Not Available

  • IMA Clinical Research San Antonio

    San Antonio, Texas 78229
    United States

    Site Not Available

  • DM Clinical Research - Sugar Land

    Sugar Land, Texas 77478
    United States

    Site Not Available

  • DM Clinical Research - Sugarland

    Sugar Land, Texas 77478
    United States

    Site Not Available

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