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A Study in India on the Immune Response and Safety of a Respiratory Syncytial Virus (RSV) Older Adults (OA) Vaccine When Given to Older Adults 60 Years of Age and Above and Adults 50-59 Years of Age at Increased Risk (AIR) of Respiratory Syncytial Virus Lower Respiratory Tract Disease (RSV-LRTD) | Clinical Trials | Clareo Health

COMPLETEDPHASE3

A Study in India on the Immune Response and Safety of a Respiratory Syncytial Virus (RSV) Older Adults (OA) Vaccine When Given to Older Adults 60 Years of Age and Above and Adults 50-59 Years of Age at Increased Risk (AIR) of Respiratory Syncytial Virus Lower Respiratory Tract Disease (RSV-LRTD)

A Phase 3, Randomized, Placebo-controlled, Observer-blind Study in India to Evaluate Immune Response, Reactogenicity and Safety of a Single Intramuscular Dose of RSVPreF3 OA Investigational Vaccine When Administered to Older Adults >=60 Years of Age and Adults 50-59 Years of Age at Increased Risk of Respiratory Syncytial Virus Lower Respiratory Tract Disease

NCT06614725•GlaxoSmithKline

View on ClinicalTrials.gov

Summary

The purpose of the study is to evaluate the immunogenicity and safety of a single dose of investigational RSVPreF3 OA vaccine in Indian older adults 60 years of age (YOA) and above and Indian adults 50-59 YOA at increased risk of RSV-LRTD.

Eligibility

Age

50 - 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.
•Written or witnessed informed consent obtained from the participant (participant must be able to understand the informed consent) prior to performance of any study-specific procedure.
•Male or female, \>= 60 YOA at the time of the study intervention administration.
•Participants who are medically stable in the opinion of the investigator at the time of 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.
•Participants living in the general community or in an assisted-living facility that provides minimal assistance can be enrolled, such that the participant is primarily responsible for self-care and activities of daily living.
•Male or female, 50-59 YOA at the time of the study intervention administration.
•Participants should be diagnosed with at least 1 of the following medical conditions and considered medically stable by the investigator:
•Chronic pulmonary disease resulting in activity restricting symptoms or use of long term medication:
•* Chronic obstructive pulmonary disease (COPD)
•* Asthma
+15 more criteria

Exclusion Criteria

•Medical Conditions
•History of any reaction or hypersensitivity likely to be exacerbated by any component of the study interventions.
•Any confirmed or suspected immunosuppressive or immunodeficient condition, resulting from disease (e.g. current malignancy, human immunodeficiency virus) or immunosuppressive/cytotoxic therapy (e.g., medication used during cancer chemotherapy, organ transplantation, or to treat autoimmune disorders), based on medical history and physical examination (no laboratory testing required).
•Unstable chronic illness.
•Recurrent history or uncontrolled 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 the eDiary, attend phone call/study site visits).
•Any history of dementia or any medical condition that moderately or severely impairs cognition.
•Significant underlying illness that in the opinion of the investigator would be expected to prevent completion of the study (e.g., life-threatening disease).
•Any medical condition that in the judgment of the investigator would make intramuscular injection unsafe.
•Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the participant due to participation in the study.
•Prior/Concomitant Therapy
+15 more criteria

Locations (14)

GSK Investigational Site

Ahmedabad, India

GSK Investigational Site

Ahmedabad, India

GSK Investigational Site

Aligarh, India

GSK Investigational Site

Bangalore, India

GSK Investigational Site

Belagavi, India

GSK Investigational Site

Darjeeling, India

GSK Investigational Site

Delhi, India

GSK Investigational Site

Kanpur, India

GSK Investigational Site

Kelambākkam, India

GSK Investigational Site

Kochi, India

Key Dates

Start Date

October 1, 2024

Primary Completion Date

June 3, 2025

Completion Date

November 14, 2025

Last Updated

December 26, 2025

Enrollment

751

ACTUAL participants

Conditions

Respiratory Syncytial Virus Infections

Interventions

RSVPreF3 OA investigational vaccine

BIOLOGICAL

Placebo

COMBINATION_PRODUCT

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: December 26, 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.

View ClinicalTrials.gov Terms and Conditions

A Study in India on the Immune Response and Safety of a Respiratory Syncytial Virus (RSV) Older Adults (OA) Vaccine When Given to Older Adults 60 Years of Age and Above and Adults 50-59 Years of Age at Increased Risk (AIR) of Respiratory Syncytial Virus Lower Respiratory Tract Disease (RSV-LRTD)

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