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A Study on Safety and Immune Response of Investigational RSV OA Vaccine in Combination With Herpes Zoster Vaccine in Healthy Adults | Clinical Trials | Clareo Health

COMPLETEDPHASE3

A Study on Safety and Immune Response of Investigational RSV OA Vaccine in Combination With Herpes Zoster Vaccine in Healthy Adults

A Phase III, Open-label, Randomized, Controlled, Multi-country Study to Evaluate the Immune Response, Safety and Reactogenicity of RSVPreF3 OA Investigational Vaccine When Co-administered With Herpes Zoster Recombinant Subunit (HZ/su) Vaccine in Adults Aged 50 Years and Older

NCT05966090•GlaxoSmithKline

View on ClinicalTrials.gov

Summary

To assess the ability of RSVPreF3 OA investigational vaccine to generate an immune response when given in combination with HZ/su vaccine and its safety in older adults, aged \>=50 years of age.

Eligibility

Age

50 - No limit years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•A male or female participant ≥50 YOA at the time of the first study intervention administration.
•Female participants of non-childbearing potential may be enrolled in the study.
•Female participants of childbearing potential may be enrolled in the study, if the participant:
•* has practiced adequate contraception from 1 month prior to study intervention administration.
•* has a negative pregnancy test on the day of and prior to study intervention administration.
•* has agreed to continue effective contraception until the end of the study.
•Participants who, in the opinion of the investigator, can and will comply with the requirements of the protocol. Written or witnessed informed consent obtained from the participant prior to any study specific procedure being performed.
•Participants living in the general community or in an assisted-living facility that provides minimal assistance, such that the participant is primarily responsible for self-care and activities of daily living.
•Participants who are medically stable in the opinion of the investigator at the time of first study intervention administration. Participants with chronic stable medical conditions with or without specific treatment, such as diabetes mellitus, hypertension, or cardiac disease, are allowed to participate in this study if considered by the investigator as medically stable.

Exclusion Criteria

•Pregnant or lactating female.
•Female planning to become pregnant or planning to discontinue contraceptive precautions.
•Any confirmed or suspected autoimmune disorders, immunosuppressive or immunodeficient condition resulting from disease or immunosuppressive/cytotoxic therapy, based on medical history and physical examination.
•History of any reaction or hypersensitivity likely to be exacerbated by any component of the study interventions, in particular any history of severe allergic reaction to any vaccine component.
•History of Guillain-Barré syndrome.
•Any history of dementia or any medical condition that moderately or severely impairs cognition.
•Recurrent or uncontrolled neurological disorders or seizures. Participants with medically controlled chronic neurological diseases can be enrolled in the study as per investigator assessment, provided that their condition will allow them to comply with the requirements of the protocol.
•Significant underlying illness that in the opinion of the investigator would be expected to prevent completion of the study.
•Any medical condition that in the judgment of the investigator would make intramuscular injection unsafe.
•Clinically suspected or polymerase chain reaction (PCR)-confirmed ongoing episode of herpes zoster.
+14 more criteria

Locations (31)

GSK Investigational Site

Daphne, Alabama, United States

GSK Investigational Site

Tempe, Arizona, United States

GSK Investigational Site

Corte Madera, California, United States

GSK Investigational Site

Aurora, Colorado, United States

GSK Investigational Site

North Miami Beach, Florida, United States

GSK Investigational Site

West Palm Beach, Florida, United States

GSK Investigational Site

Columbus, Georgia, United States

GSK Investigational Site

Versailles, Kentucky, United States

GSK Investigational Site

New Orleans, Louisiana, United States

GSK Investigational Site

Fort Worth, Texas, United States

Key Dates

Start Date

July 28, 2023

Primary Completion Date

February 19, 2024

Completion Date

July 29, 2024

Last Updated

April 1, 2025

Enrollment

530

ACTUAL participants

Conditions

Respiratory Syncytial VirusesRespiratory Syncytial Virus Infections

Interventions

RSVPreF3 OA investigational vaccine

BIOLOGICAL

HZ/su vaccine

BIOLOGICAL

A Study on the Immune Response and Safety of Vaccine Against Respiratory Syncytial Virus Given to Chinese Adults 18 to 59 Years of Age at Increased Risk of Respiratory Syncytial Virus Disease

NCT07220109

Respiratory Syncytial Virus Infections

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RECRUITINGPHASE2

A Study Evaluating Persistence of the Immune Response of the Adjuvanted Respiratory Syncytial Virus (RSV) Vaccine and the Safety and Immune Response Following Revaccination in Adults 18 Years of Age and Above Who Received Lung or Kidney Transplant

NCT07092865

Respiratory Syncytial Virus Infections

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 1, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study on Safety and Immune Response of Investigational RSV OA Vaccine in Combination With Herpes Zoster Vaccine in Healthy Adults

Inclusion Criteria

Exclusion Criteria

A Study on the Immune Response and Safety of Vaccine Against Respiratory Syncytial Virus Given to Chinese Adults 18 to 59 Years of Age at Increased Risk of Respiratory Syncytial Virus Disease

A Study Evaluating Persistence of the Immune Response of the Adjuvanted Respiratory Syncytial Virus (RSV) Vaccine and the Safety and Immune Response Following Revaccination in Adults 18 Years of Age and Above Who Received Lung or Kidney Transplant

Genotype and Disease Burden of RSV in Older Vietnamese Adults (RSV: Respiratory Syncytial Virus )

An Extension and Crossover Vaccination Study on the Immune Response and Safety of a Vaccine Against Respiratory Syncytial Virus Given to Adults 60 Years of Age and Above Who Participated in RSV OA=ADJ-006 Study

Safety and Immunogenicity of CodaVax-RSV in Seropositive and Seronegative Children

Evaluating the Benefits of RSV Maternal Vaccination Using a Scottish National Dataset