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

Completed · Phase 3

Conditions studied: Respiratory Syncytial Virus (RSV)

In brief

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.

Key facts

Study ID

NCT06890416

Run by

Pfizer

People needed

526

Starts

2025-04-04

Expected to finish

2025-09-30

Last updated by the study team

2025-11-06

Who can join

Age: 50 and older. Sex: any. Healthy volunteers: accepted.

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.

Where it is running

• Central Research Associates — Birmingham, Alabama, United States
• Medical Affiliated Research Center — Huntsville, Alabama, United States
• AMR Clinical — Mobile, Alabama, United States
• Kaiser Permanente — Los Angeles, California, United States
• Diablo Clinical Research, Inc. — Walnut Creek, California, United States
• Alliance for Multispecialty Research, LLC — Doral, Florida, United States
• Proactive Clinical Research,LLC — Fort Lauderdale, Florida, United States
• De La Cruz Research Center, LLC — Miami, Florida, United States
• Centricity Research Columbus Georgia Multispecialty — Columbus, Georgia, United States
• Clinical Research Atlanta — Stockbridge, Georgia, United States
• Synexus Clinical Research US, Inc. — Chicago, Illinois, United States
• Optimal Research — Peoria, Illinois, United States
• DelRicht Research — New Orleans, Louisiana, United States
• Jadestone Clinical Research — Silver Spring, Maryland, United States
• Oakland Medical Research — Troy, Michigan, United States
• Clinical Research Professionals — Chesterfield, Missouri, United States
• IMA Clinical Research Warren — Warren Township, New Jersey, United States
• NYU Langone Health — New York, New York, United States
• Centricity Research Columbus Ohio Multispecialty — Columbus, Ohio, United States
• DM Clinical Research - Philadelphia — Philadelphia, Pennsylvania, United States
• Clinical Neuroscience Solutions Inc. — Memphis, Tennessee, United States
• DM Clinical Research - Bellaire — Houston, Texas, United States
• SMS Clinical Research — Mesquite, Texas, United States
• IMA Clinical Research San Antonio — San Antonio, Texas, United States
• DM Clinical Research - Sugar Land — Sugar Land, Texas, United States

Full record on ClinicalTrials.gov

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