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

NCT ID: NCT06890416

Last Updated: 2025-11-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

526 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-04

Study Completion Date

2025-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Respiratory Syncytial Virus (RSV)

Keywords

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RSV Vaccine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Coadministration Group

* Visit 1 (Day 1): RSVpreF + HZ/su dose 1
* Visit 3 (Month 2): HZ/su dose 2

Group Type OTHER

RESPIRATORY SYNCYTIAL VIRUS PREFUSION F SUBUNIT VACCINE

Intervention Type BIOLOGICAL

Intramuscular injection

HZ/su VACCINE

Intervention Type BIOLOGICAL

intramuscular injection

Sequential Administration Group

* Visit 1 (Day 1): HZ/su dose 1
* Visit 2 (Month 1): RSVpreF
* Visit 3 (Month 2): HZ/su dose 2

Group Type OTHER

RESPIRATORY SYNCYTIAL VIRUS PREFUSION F SUBUNIT VACCINE

Intervention Type BIOLOGICAL

Intramuscular injection

HZ/su VACCINE

Intervention Type BIOLOGICAL

intramuscular injection

Interventions

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RESPIRATORY SYNCYTIAL VIRUS PREFUSION F SUBUNIT VACCINE

Intramuscular injection

Intervention Type BIOLOGICAL

HZ/su VACCINE

intramuscular injection

Intervention Type BIOLOGICAL

Other Intervention Names

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ABRYSVO RSVpreF PF-06928316 SHINGRIX RZV HZ/su

Eligibility Criteria

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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.
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Central Research Associates

Birmingham, Alabama, United States

Site Status

Medical Affiliated Research Center

Huntsville, Alabama, United States

Site Status

AMR Clinical

Mobile, Alabama, United States

Site Status

Kaiser Permanente

Los Angeles, California, United States

Site Status

Diablo Clinical Research, Inc.

Walnut Creek, California, United States

Site Status

Alliance for Multispecialty Research, LLC

Doral, Florida, United States

Site Status

Proactive Clinical Research,LLC

Fort Lauderdale, Florida, United States

Site Status

De La Cruz Research Center, LLC

Miami, Florida, United States

Site Status

Centricity Research Columbus Georgia Multispecialty

Columbus, Georgia, United States

Site Status

Clinical Research Atlanta

Stockbridge, Georgia, United States

Site Status

Synexus Clinical Research US, Inc.

Chicago, Illinois, United States

Site Status

Optimal Research

Peoria, Illinois, United States

Site Status

DelRicht Research

New Orleans, Louisiana, United States

Site Status

Jadestone Clinical Research

Silver Spring, Maryland, United States

Site Status

Oakland Medical Research

Troy, Michigan, United States

Site Status

Clinical Research Professionals

Chesterfield, Missouri, United States

Site Status

IMA Clinical Research Warren

Warren Township, New Jersey, United States

Site Status

NYU Langone Health

New York, New York, United States

Site Status

Centricity Research Columbus Ohio Multispecialty

Columbus, Ohio, United States

Site Status

DM Clinical Research - Philadelphia

Philadelphia, Pennsylvania, United States

Site Status

Clinical Neuroscience Solutions Inc.

Memphis, Tennessee, United States

Site Status

DM Clinical Research - Bellaire

Houston, Texas, United States

Site Status

SMS Clinical Research

Mesquite, Texas, United States

Site Status

IMA Clinical Research San Antonio

San Antonio, Texas, United States

Site Status

DM Clinical Research - Sugar Land

Sugar Land, Texas, United States

Site Status

Clinical Research Puerto Rico

San Juan, , Puerto Rico

Site Status

Countries

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United States Puerto Rico

Related Links

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https://pmiform.com/clinical-trial-info-request?StudyID=C3671058

To obtain contact information for a study center near you, click here.

Other Identifiers

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PISSARRO

Identifier Type: OTHER

Identifier Source: secondary_id

C3671058

Identifier Type: -

Identifier Source: org_study_id