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)

NCT06614725 | Completed Phase 3

• 1 other identifier: 221265
• Study Type: interventional
• Target: 751
• Locations: 1 country
• Sites: 14

Brief 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.

Conditions

Respiratory Syncytial Virus Infections

Keywords

RSV; Respiratory Syncytial Virus; RSVPreF3 OA vaccine; Immunogenicity; Safety; Reactogenicity; At increased risk (AIR); Older Adults; Respiratory syncytial virus lower respiratory tract disease (RSV-LRTD)

Outcome Measures

Primary Outcomes (4)

• RSV-A neutralizing titers expressed as Geometric Mean Titers (GMTs)

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

  At Day 1 (pre-study intervention administration)

• RSV-A neutralizing titers expressed as GMTs

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

  At Day 31 (1 month post-study intervention administration)

• RSV-B neutralizing titers expressed as GMTs

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

  At Day 1 (pre-study intervention administration)

• RSV-B neutralizing titers expressed as GMTs

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

  At Day 31 (1 month post-study intervention administration)

Secondary Outcomes (7)

• Number of participants reporting any solicited administration site events

  Day 1 (day of administration) to Day 4

• Number of participants reporting any solicited systemic events

  Day 1 (day of administration) to Day 4

• Number of participants reporting any unsolicited AEs

  Day 1 to Day 30

• Number of participants reporting any serious adverse events (SAEs)

  From Day 1 up to data lock point of primary analysis (median follow-up: 176 days)

• Number of participants reporting any SAEs

  From Day 1 up to study end (approximately 6 months post study intervention administration)

Study Arms (4)

OA-RSV group

EXPERIMENTAL

Older adult (OA) participants, greater than or equal to (≥) 60 years of age (YOA), received a single dose of RSVPreF3 OA investigational vaccine at Day 1.

Biological: RSVPreF3 OA investigational vaccine

OA-Placebo group

PLACEBO COMPARATOR

OA participants, ≥ 60 YOA, received a single dose of placebo at Day 1.

Combination Product: Placebo

Adults-AIR-RSV group

EXPERIMENTAL

Adult participants, 50-59 YOA, at increased risk (AIR) of Respiratory Syncytial Virus - Lower Respiratory Tract Disease (RSV-LRTD), received a single dose of RSVPreF3 OA investigational vaccine at Day 1.

Biological: RSVPreF3 OA investigational vaccine

Adults-AIR-Placebo group

PLACEBO COMPARATOR

Adult participants, 50-59 YOA, at increased risk (AIR) of RSV-LRTD, received a single dose of placebo at Day 1.

Combination Product: Placebo

Interventions

RSVPreF3 OA investigational vaccine BIOLOGICAL

1 dose of RSVPreF3 OA investigational vaccine administered intramuscularly on Day 1 to participants in OA-RSV and Adults-AIR-RSV groups.

Adults-AIR-RSV group; OA-RSV group

Placebo COMBINATION_PRODUCT

1 dose of placebo (saline solution) administered intramuscularly on Day 1 to participants in OA-Placebo and Adults-AIR-Placebo groups.

Adults-AIR-Placebo group; OA-Placebo group

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Cystic fibrosis
• Other chronic respiratory diseases: lung fibrosis, restrictive lung disease, interstitial lung disease, emphysema, or bronchiectasis
• Chronic cardiovascular disease:
• Chronic heart failure (CHF)
• Pre-existing coronary artery disease (CAD not otherwise specified)

You may not qualify if:

• 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
• Use of any investigational or non-registered product (drug, vaccine or invasive medical device) other than the study interventions during the period beginning 30 days (Day -29 to Day 1) before the dose of study interventions or their planned use during the study period (Day 1 up to Month 6).
• Previous vaccination with licensed or investigational RSV vaccine. 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 (fully licensed or with emergency use authorization \[EUA\]) which can be administered up to 14 days before or from 14 days after the study intervention administration.
• Chronic administration of immune-modifying drugs (defined as more than 14 consecutive days in total) and/or planned use of long-acting immune-modifying treatments at any time up to the end of the study.
• Up to 3 months prior to the study intervention administration:
• For corticosteroids, this will mean prednisone equivalent \>= 20 mg/day for adult participants. Inhaled and topical steroids are allowed.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (14)

GSK Investigational Site

Ahmedabad, 380015, India

Location

GSK Investigational Site

Ahmedabad, 380061, India

Location

GSK Investigational Site

Aligarh, 202002, India

Location

GSK Investigational Site

Bangalore, 560002, India

Location

GSK Investigational Site

Belagavi, 590019, India

Location

GSK Investigational Site

Darjeeling, 734012, India

Location

GSK Investigational Site

Delhi, 110060, India

Location

GSK Investigational Site

Kanpur, 208002, India

Location

GSK Investigational Site

Kelambākkam, 603103, India

Location

GSK Investigational Site

Kochi, 682026, India

Location

GSK Investigational Site

Kolkata, 700073, India

Location

GSK Investigational Site

Pune-411 043, 411043, India

Location

GSK Investigational Site

Raipur, India

Location

GSK Investigational Site

Vadu Budruk Pune, 412216, India

Location

MeSH Terms

Conditions

Respiratory Syncytial Virus Infections

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Click here to enter text.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2024
• First Posted: September 26, 2024
• Study Start: October 1, 2024
• Primary Completion: June 3, 2025
• Study Completion: November 14, 2025
• Last Updated: December 26, 2025

Record last verified: 2025-12

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

IN (14)