Status:
COMPLETED
A Study to Evaluate the Safety and Immunogenicity of RSVpreF Coadministered With Herpes Zoster Vaccine in Adults
Lead Sponsor:
Pfizer
Conditions:
Respiratory Syncytial Virus (RSV)
Eligibility:
All Genders
50+ years
Phase:
PHASE3
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 ...
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.
Exclusion
Key Trial Info
Start Date :
April 4 2025
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 30 2025
Estimated Enrollment :
526 Patients enrolled
Trial Details
Trial ID
NCT06890416
Start Date
April 4 2025
End Date
September 30 2025
Last Update
November 6 2025
Active Locations (26)
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1
Central Research Associates
Birmingham, Alabama, United States, 35205
2
Medical Affiliated Research Center
Huntsville, Alabama, United States, 35801
3
AMR Clinical
Mobile, Alabama, United States, 36608
4
Kaiser Permanente
Los Angeles, California, United States, 90027