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A Study on the Immune Response and Safety Elicited by a Vaccine Against Respiratory Syncytial Virus (RSV) When Given Alone and Together With a Vaccine Against Influenza in Adults Aged 65 Years and Above | Clinical Trials | Clareo Health

COMPLETEDPHASE3

A Study on the Immune Response and Safety Elicited by a Vaccine Against Respiratory Syncytial Virus (RSV) When Given Alone and Together With a Vaccine Against Influenza in Adults Aged 65 Years and Above

A Phase 3, Open-label, Randomized, Controlled, Multicountry Study to Evaluate the Immune Response, Safety and Reactogenicity of RSVPreF3 OA Investigational Vaccine When Co-administered With FLU HD Vaccine in Adults Aged 65 Years and Above

NCT05559476•GlaxoSmithKline

View on ClinicalTrials.gov

Summary

The purpose of this study is to assess the immunogenicity, safety and reactogenicity of the RSVPreF3 OA investigational vaccine when co-administered with the high dose quadrivalent influenza (FLU HD) vaccine in adults aged 65 years and above compared to separate administration of the vaccines.

Eligibility

Age

65 - No limit years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Participants, who, in the opinion of the investigator, can and will comply with the requirements of the protocol
•A male or female ≥65 years of age at the time of the first study intervention administration.
•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.
•Written or witnessed informed consent obtained from the participant prior to performance of any study-specific procedure.
•Participants who are medically stable in the opinion of the investigator at the time of first vaccination. Participants with chronic stable medical conditions with or without specific treatment are allowed to participate in this study if considered by the investigator as medically stable.

Exclusion Criteria

•Medical conditions
•Any confirmed or suspected immunosuppressive or immunodeficient condition resulting from disease or immunosuppressive/cytotoxic therapy, based on medical history and physical examination (no laboratory testing required).
•History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccines.
•Hypersensitivity to latex.
•History of Guillain Barré syndrome, or anaphylaxis.
•Serious or unstable chronic illness.
•Any history of dementia or any medical condition that moderately or severely impairs cognition.
•Recurrent or un-controlled neurological disorders or seizures. Participants with medically-controlled active or 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 (e.g. completion of diary cards, attend regular phone calls/study site visits).
•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.
+16 more criteria

Locations (46)

GSK Investigational Site

Birmingham, Alabama, United States

GSK Investigational Site

Tempe, Arizona, United States

GSK Investigational Site

Canoga Park, California, United States

GSK Investigational Site

Colton, California, United States

GSK Investigational Site

Sacramento, California, United States

GSK Investigational Site

San Diego, California, United States

GSK Investigational Site

Walnut Creek, California, United States

GSK Investigational Site

Aurora, Colorado, United States

GSK Investigational Site

Coral Gables, Florida, United States

GSK Investigational Site

Fort Myers, Florida, United States

Key Dates

Start Date

October 20, 2022

Primary Completion Date

March 7, 2023

Completion Date

August 15, 2023

Last Updated

September 24, 2024

Enrollment

1,029

ACTUAL participants

Conditions

Respiratory Syncytial Virus Infections

Interventions

RSVPreF3 OA investigational vaccine

BIOLOGICAL

FLU HD 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

View study

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

View study

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: September 24, 2024Data 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 the Immune Response and Safety Elicited by a Vaccine Against Respiratory Syncytial Virus (RSV) When Given Alone and Together With a Vaccine Against Influenza in Adults Aged 65 Years and Above

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