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

NCT06389487 | Completed Phase 3 Results FDA Drug

• 2 other identifiers: 2222532023-510190-34-00
• Study Type: interventional
• Target: 1,459
• Locations: 6 countries
• Sites: 52

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

Keywords

Respiratory Syncytial Virus (RSV); Immunogenicity; Safety; Non-inferiority; Humoral immune response; At increased risk (AIR); Older Adults

Outcome Measures

Primary Outcomes (4)

• Part A: RSV-A Neutralizing Titers Expressed as Group Geometric Mean Titers (GMTs)

  RSV-A neutralizing titers are given as group GMTs and are expressed as Estimated dilution 60 (ED60)

  At Day 31

• Part A: Percentage of Participants With Seroresponse Rate (SRR) in RSV-A Neutralizing Titers

  SRR is defined as the percentage of participants having a fold increase in neutralizing titers (1 month post-study intervention administration over pre-study intervention administration) ≥4. RSV-A neutralizing titers are expressed as ED60.

  Day 31 compared with baseline (Day 1)

• Part A: RSV-B Neutralizing Titers Expressed as Group GMTs

  RSV-B neutralizing titers are given as group GMTs and are expressed as ED60.

  At Day 31

• Part A: Percentage of Participants With SRR in RSV-B Neutralizing Titers

  SRR is defined as the percentage of participants having a fold increase in neutralizing titers (1-month post-study intervention administration over pre-study intervention administration) ≥ 4. RSV-B neutralizing titers are expressed as ED60.

  Day 31 compared with baseline (Day 1)

Secondary Outcomes (7)

• Part A and B: Number of Participants Reporting Any Solicited Administration Site Events

  Day 1 (post dose) to Day 4

• Part A and B: Number of Participants Reporting Any Solicited Systemic Events

  Day 1 (post dose) to Day 4

• Part A and B: Number of Participants Reporting Unsolicited Adverse Events (AEs)

  Day 1 (post dose) to Day 30

• Part A and B: Number of Participants Reporting Any Serious Adverse Events (SAEs), Related SAEs and Fatal SAEs

  Throughout the study period (Day 1 to Month 6)

• Part A and B: Number of Participants Reporting Any Adverse Events of Special Interest (AESIs)

  Throughout the study period (Day 1 to Month 6)

Study Arms (3)

Part A: RSV-A-AIR Group

EXPERIMENTAL

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.

Biological: RSVPreF3 OA investigational vaccine

Part A: RSV-OA Group

ACTIVE COMPARATOR

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

Biological: RSVPreF3 OA investigational vaccine

Part B: RSV-A-AIR Group

EXPERIMENTAL

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.

Biological: RSVPreF3 OA investigational vaccine

Interventions

RSVPreF3 OA investigational vaccine BIOLOGICAL

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

Part A: RSV-A-AIR Group; Part A: RSV-OA Group; Part B: RSV-A-AIR Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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:

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (52)

GSK Investigational Site

Glendale, Arizona, 85308, United States

Location

GSK Investigational Site

Phoenix, Arizona, 85284, United States

Location

GSK Investigational Site

North Hollywood, California, 91606-3287, United States

Location

GSK Investigational Site

Oakland, California, 94610, United States

Location

GSK Investigational Site

Walnut Creek, California, 94598, United States

Location

GSK Investigational Site

Hialeah, Florida, 33012, United States

Location

GSK Investigational Site

North Miami, Florida, 33173, United States

Location

GSK Investigational Site

Orlando, Florida, 32806, United States

Location

GSK Investigational Site

Lexington, Kentucky, 40509, United States

Location

GSK Investigational Site

Silver Spring, Maryland, 20904, United States

Location

GSK Investigational Site

Rochester, New York, 14609, United States

Location

GSK Investigational Site

Oklahoma City, Oklahoma, 73111, United States

Location

GSK Investigational Site

Knoxville, Tennessee, 37909, United States

Location

GSK Investigational Site

DeSoto, Texas, 75115, United States

Location

GSK Investigational Site

Charlottesville, Virginia, 22911, United States

Location

GSK Investigational Site

Wenatchee, Washington, 98801, United States

Location

GSK Investigational Site

Coffs Harbour, New South Wales, 2450, Australia

Location

GSK Investigational Site

Sydney, New South Wales, 2010, Australia

Location

GSK Investigational Site

Sydney, New South Wales, 2065, Australia

Location

GSK Investigational Site

Fortitude Valley, Queensland, 4006, Australia

Location

GSK Investigational Site

Tarragindi, Queensland, 4121, Australia

Location

GSK Investigational Site

Melbourne, Victoria, 3051, Australia

Location

GSK Investigational Site

St Albans, Victoria, 3021, Australia

Location

GSK Investigational Site

New Westminster, British Columbia, V3L 3W4, Canada

Location

GSK Investigational Site

Victoria, British Columbia, V8V 4A1, Canada

Location

GSK Investigational Site

Truro, Nova Scotia, B2N 1L2, Canada

Location

GSK Investigational Site

Greater Sudbury, Ontario, P3C 1X3, Canada

Location

GSK Investigational Site

Guelph, Ontario, N1G 0B4, Canada

Location

GSK Investigational Site

London-Ontario, Ontario, N5W 6A2, Canada

Location

GSK Investigational Site

Toronto, Ontario, M4G 3E8, Canada

Location

GSK Investigational Site

Québec, Quebec, G1N 4V3, Canada

Location

GSK Investigational Site

Québec, Quebec, G1V 4G2, Canada

Location

GSK Investigational Site

Québec, Quebec, G1V 4W2, Canada

Location

GSK Investigational Site

Saint-Charles-Borromée, Quebec, J6E 2B4, Canada

Location

GSK Investigational Site

Sherbrooke, Quebec, J1J 2G2, Canada

Location

GSK Investigational Site

Weinheim, Baden-Wurttemberg, 69469, Germany

Location

GSK Investigational Site

Berlin, 10117, Germany

Location

GSK Investigational Site

Berlin, 10787, Germany

Location

GSK Investigational Site

Berlin, 13347, Germany

Location

GSK Investigational Site

Essen, 45355, Germany

Location

GSK Investigational Site

Mainz, 55116, Germany

Location

GSK Investigational Site

Wallerfing, 94574, Germany

Location

GSK Investigational Site

Witten, 58455, Germany

Location

GSK Investigational Site

Würzburg, 97070, Germany

Location

GSK Investigational Site

Ibaraki, 300-0062, Japan

Location

GSK Investigational Site

Kanagawa, 211-0041, Japan

Location

GSK Investigational Site

Tokyo, 155-0031, Japan

Location

GSK Investigational Site

Tokyo, 180-0022, Japan

Location

GSK Investigational Site

Cape Town, 7530, South Africa

Location

GSK Investigational Site

Cape Town, 7700, South Africa

Location

GSK Investigational Site

Johannesburg, 2113, South Africa

Location

GSK Investigational Site

Reiger Park, 1459, South Africa

Location

MeSH Terms

Conditions

Respiratory Syncytial Virus Infections

Condition Hierarchy (Ancestors)

Pneumovirus Infections; Paramyxoviridae Infections; Mononegavirales Infections; RNA Virus Infections; Virus Diseases; Infections

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

GSKClinicalSupportHD@gsk.com

866-435-7343

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2024
• First Posted: April 29, 2024
• Study Start: April 29, 2024
• Primary Completion: July 29, 2024
• Study Completion: March 18, 2025
• Last Updated: September 25, 2025
• Results First Posted: September 25, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications.
• Access Criteria: Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension may be granted, when justified, for up to 6 months.

Locations

ZA (4); CA (12); AU (7); JP (4); US (16); DE (9)