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

CompletedPhase 3

Sponsor: Pfizer

Conditions: Respiratory Syncytial Virus (RSV)

Interventions: RESPIRATORY SYNCYTIAL VIRUS PREFUSION F SUBUNIT VACCINE, HZ/su VACCINE

Countries: United States, Puerto Rico

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 overview

Sex: ALL

Age: 50 Years to —

Healthy volunteers: Yes

Study type: INTERVENTIONAL

Eligibility criteria

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.

Locations (26)

Birmingham, Alabama, United States
Huntsville, Alabama, United States
Mobile, Alabama, United States
Los Angeles, California, United States
Walnut Creek, California, United States
Doral, Florida, United States
Fort Lauderdale, Florida, United States
Miami, Florida, United States
Columbus, Georgia, United States
Stockbridge, Georgia, United States
Chicago, Illinois, United States
Peoria, Illinois, United States
New Orleans, Louisiana, United States
Silver Spring, Maryland, United States
Troy, Michigan, United States
Chesterfield, Missouri, United States
Warren Township, New Jersey, United States
New York, New York, United States
Columbus, Ohio, United States
Philadelphia, Pennsylvania, United States
Memphis, Tennessee, United States
Houston, Texas, United States
Mesquite, Texas, United States
San Antonio, Texas, United States
Sugar Land, Texas, United States
San Juan, Puerto Rico