A Study on the Immune Response and Safety of Vaccine Against Respiratory Syncytial Virus (RSV) Given to Adults 18 to 49 Years of Age at Increased Risk for Respiratory Syncytial Virus Disease, Compared to Older Adults 60 Years of Age and Above

NCT ID: NCT06389487

Last Updated: 2025-09-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 1459 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-29
• Study Completion Date: 2025-03-18

Brief Summary

The aim of this study is to demonstrate the immune response and to evaluate the safety of the RSVPreF3 OA investigational vaccine in non-immunocompromised adults 18-49 years of age (YOA), who are at increased risk (AIR) for RSV disease, compared to older adults (OA) 60 YOA and above.

Conditions

Respiratory Syncytial Virus Infections

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Part A: RSV-A-AIR Group

Adult (A) participants, 18-49 YOA, at increased risk (AIR) for RSV disease, received a single dose of RSVPreF3 OA investigational vaccine at Day 1. Participants in this group were considered for all study analyses, as per protocol.

Group Type: EXPERIMENTAL

RSVPreF3 OA investigational vaccine

Intervention Type: BIOLOGICAL

1 dose of RSVPreF3 OA investigational vaccine is administered intramuscularly on Day 1.

Part A: RSV-OA Group

Older adults (OA) participants, ≥60 YOA, received a single dose of RSVPreF3 OA investigational vaccine at Day 1.

Group Type: ACTIVE_COMPARATOR

RSVPreF3 OA investigational vaccine

Intervention Type: BIOLOGICAL

1 dose of RSVPreF3 OA investigational vaccine is administered intramuscularly on Day 1.

Part B: RSV-A-AIR Group

Adult participants, 18-49 YOA, AIR for RSV disease, received a single dose of RSVPreF3 OA investigational vaccine at Day 1. Participants in this group were considered only for Participant flow, Baseline Characteristics and all safety analyses, as per protocol.

Group Type: EXPERIMENTAL

RSVPreF3 OA investigational vaccine

Intervention Type: BIOLOGICAL

1 dose of RSVPreF3 OA investigational vaccine is administered intramuscularly on Day 1.

Interventions

RSVPreF3 OA investigational vaccine

1 dose of RSVPreF3 OA investigational vaccine is administered intramuscularly on Day 1.

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• Participants and/or participant's parent(s)/ Legally acceptable representative (LAR) who, in the opinion of the investigator, can and will comply with the requirements of the protocol (e.g., completion of the eDiary, attend study site visits, ability to access and utilize a phone or other electronic communications).
• Written or witnessed informed consent obtained from the participant/participant's parent(s)/LAR(s) (participant must be able to understand the informed consent) prior to performance of any study-specific procedure.

Written informed assent obtained from the participant (participant must be able to understand the informed assent) if he/she is less than the legal age prior to performance of any study-specific procedure.

• Participants should be diagnosed with at least 1 of the following medical conditions if considered medically stable by the investigator:

• Chronic cardiopulmonary disease resulting in activity restricting symptoms or use of long term medication:

o Chronic obstructive pulmonary disease (COPD)

o Asthma

o Cystic fibrosis

o Other chronic respiratory diseases: lung fibrosis, restrictive lung disease, interstitial lung disease, emphysema or bronchiectasis

o Chronic heart failure:

o Pre-existing Coronary Artery Disease (CAD) (CAD not otherwise specified)

• Cardiac arrhythmia
• Diabetes mellitus: types 1 or 2 with active treatment for the past 6 months
• Other diseases at increased risk for RSV disease:

• Chronic kidney disease
• Chronic moderate to severe liver disease
• Neurologic or neuromuscular conditions
• Female participants of non-childbearing potential may be enrolled in the study. Non-childbearing potential is defined as premenarche, hysterectomy, bilateral oophorectomy, bilateral salpingectomy or post-menopause.
• 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, and
• has a negative pregnancy test on the day of study prior to intervention administration, and
• has agreed to continue adequate contraception for at least 1 month after completion of the study intervention administration.

• A male or female participant >=60 YOA at the time of the study intervention administration.

Participants with chronic stable medical conditions with or without specific treatment, such as diabetes, hypertension or cardiac disease are allowed to participate in this study if considered medically stable by the investigator.

• 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.

Exclusion Criteria

Medical conditions

• 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).
• History of any reaction or hypersensitivity likely to be exacerbated by any component of the study intervention.
• Unstable chronic illness.
• 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 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 diary cards, attend study site visits). Study participants may decide to assign a caregiver to help them complete the study procedures.
• 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

• Use of any investigational or non-registered product (drug, vaccine, or medical device) other than the study intervention during the period beginning 30 days before the dose of study intervention (Day -29 to Day 1), or planned use during the study period (up to Visit 3, Month 6).
• Planned or actual administration of a vaccine not foreseen by the study protocol in the period starting 30 days before and ending 30 days after the dose of study intervention administration, with the exception of inactivated, subunit and split influenza vaccines or COVID-19 vaccines which can be administered up to 14 days before or from 14 days after the study intervention administration.
• Previous vaccination with any RSV vaccine, including investigational RSV vaccines.
• Chronic administration of immune-modifying drugs (defined as more than 14 consecutive days in total) and/or administration of long-acting immune-modifying treatments or planned administration at any time up to the End-of-study (EOS).

• Up to 3 months prior to the study intervention administration:

• For corticosteroids, this will mean prednisone >=20 mg/day, or equivalent. Inhaled, topical and intra-articular steroids are allowed
• Administration of immunoglobulins and/or any blood products or plasma derivatives
• Up to 6 months prior to study intervention administration: long-acting immune-modifying drugs including among others immunotherapy (e.g., Tumor Necrosis Factor (TNF)-inhibitors), monoclonal antibodies, antitumoral medication.

Prior/Concurrent clinical study experience

• Concurrently participating in another clinical study, at any time during the study period, in which the participant has been or will be exposed to an investigational or a non-investigational vaccine/product (drug or invasive medical device).

Other exclusions:

Other exclusions for all participants:

• History of chronic alcohol consumption and/or drug abuse as deemed by the investigator to render the potential participant unable/unlikely to provide accurate safety reports or comply with study procedures.
• Bedridden participants.
• Planned move during the study period that will prohibit participating in the study until study end.
• Participation of any study personnel or their immediate dependents, family, or household members.

Other exclusions for Cohort 1 and Cohort 3:

• Pregnant or lactating female participant.
• Female planning to become pregnant or planning to discontinue contraceptive precautions within 1 month after study intervention administration.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

GSK Investigational Site

Québec, Quebec, Canada

GSK Investigational Site

Québec, Quebec, Canada

GSK Investigational Site

Québec, Quebec, Canada

GSK Investigational Site

Glendale, Arizona, United States

GSK Investigational Site

Phoenix, Arizona, United States

GSK Investigational Site

North Hollywood, California, United States

GSK Investigational Site

Oakland, California, United States

GSK Investigational Site

Walnut Creek, California, United States

GSK Investigational Site

Hialeah, Florida, United States

GSK Investigational Site

North Miami, Florida, United States

GSK Investigational Site

Orlando, Florida, United States

GSK Investigational Site

Lexington, Kentucky, United States

GSK Investigational Site

Silver Spring, Maryland, United States

GSK Investigational Site

Rochester, New York, United States

GSK Investigational Site

Oklahoma City, Oklahoma, United States

GSK Investigational Site

Knoxville, Tennessee, United States

GSK Investigational Site

DeSoto, Texas, United States

GSK Investigational Site

Charlottesville, Virginia, United States

GSK Investigational Site

Wenatchee, Washington, United States

GSK Investigational Site

Coffs Harbour, New South Wales, Australia

GSK Investigational Site

Sydney, New South Wales, Australia

GSK Investigational Site

Sydney, New South Wales, Australia

GSK Investigational Site

Fortitude Valley, Queensland, Australia

GSK Investigational Site

Tarragindi, Queensland, Australia

GSK Investigational Site

Melbourne, Victoria, Australia

GSK Investigational Site

St Albans, Victoria, Australia

GSK Investigational Site

New Westminster, British Columbia, Canada

GSK Investigational Site

Victoria, British Columbia, Canada

GSK Investigational Site

Truro, Nova Scotia, Canada

GSK Investigational Site

Greater Sudbury, Ontario, Canada

GSK Investigational Site

Guelph, Ontario, Canada

GSK Investigational Site

London-Ontario, Ontario, Canada

GSK Investigational Site

Toronto, Ontario, Canada

GSK Investigational Site

Saint-Charles-Borromée, Quebec, Canada

GSK Investigational Site

Sherbrooke, Quebec, Canada

GSK Investigational Site

Weinheim, Baden-Wurttemberg, Germany

GSK Investigational Site

Berlin, , Germany

GSK Investigational Site

Berlin, , Germany

GSK Investigational Site

Berlin, , Germany

GSK Investigational Site

Essen, , Germany

GSK Investigational Site

Mainz, , Germany

GSK Investigational Site

Wallerfing, , Germany

GSK Investigational Site

Witten, , Germany

GSK Investigational Site

Würzburg, , Germany

GSK Investigational Site

Ibaraki, , Japan

GSK Investigational Site

Kanagawa, , Japan

GSK Investigational Site

Tokyo, , Japan

GSK Investigational Site

Tokyo, , Japan

GSK Investigational Site

Cape Town, , South Africa

GSK Investigational Site

Cape Town, , South Africa

GSK Investigational Site

Johannesburg, , South Africa

GSK Investigational Site

Reiger Park, , South Africa

Countries

United States; Australia; Canada; Germany; Japan; South Africa

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

2023-510190-34-00

Identifier Type: OTHER

Identifier Source: secondary_id

222253

Identifier Type: -

Identifier Source: org_study_id