Last updated: 12/25/2025 12:10:51

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)

GSK study ID
221265
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: 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
Trial description: 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.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation:
Randomized
Primary outcomes:

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

Timeframe: At Day 1 (pre-study intervention administration)

RSV-A neutralizing titers expressed as GMTs

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

RSV-B neutralizing titers expressed as GMTs

Timeframe: At Day 1 (pre-study intervention administration)

RSV-B neutralizing titers expressed as GMTs

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

Secondary outcomes:

Number of participants reporting any solicited administration site events

Timeframe: Day 1 (day of administration) to Day 4

Number of participants reporting any solicited systemic events

Timeframe: Day 1 (day of administration) to Day 4

Number of participants reporting any unsolicited AEs

Timeframe: Day 1 to Day 30

Number of participants reporting any serious adverse events (SAEs)

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

Number of participants reporting any SAEs

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

Number of participants reporting any pIMDs

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

Number of participants reporting any pIMDs

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

Interventions:
  • Biological/vaccine: RSVPreF3 OA investigational vaccine
  • Combination product: Placebo
  • Enrollment:
    751
    Primary completion date:
    2025-03-06
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Respiratory Syncytial Virus Infections
    Product
    Not applicable
    Collaborators
    Not applicable
    Study date(s)
    October 2024 to November 2025
    Type
    Interventional
    Phase
    3

    Participation criteria

    Sex
    Female & Male
    Age
    50+ years
    Accepts healthy volunteers
    Yes
    • 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.
    • Medical Conditions
    • History of any reaction or hypersensitivity likely to be exacerbated by any component of the study interventions.

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Raipur, India
    Status
    Study Complete
    Location
    GSK Investigational Site
    Ahmedabad, India, 380015
    Status
    Study Complete
    Location
    GSK Investigational Site
    Vadu Budruk Pune, India, 412216
    Status
    Study Complete
    Location
    GSK Investigational Site
    Belagavi, India, 590019
    Status
    Study Complete
    Location
    GSK Investigational Site
    Kanpur, India, 208002
    Status
    Study Complete
    Location
    GSK Investigational Site
    Kelambakkam, India, 603103
    Status
    Study Complete
    Location
    GSK Investigational Site
    Bangalore, India, 560002
    Status
    Study Complete
    Location
    GSK Investigational Site
    Kolkata, India, 700073
    Status
    Study Complete
    Location
    GSK Investigational Site
    Darjeeling, India, 734012
    Status
    Study Complete
    Location
    GSK Investigational Site
    Kochi, India, 682026
    Status
    Study Complete
    Location
    GSK Investigational Site
    Aligarh, India, 202002
    Status
    Study Complete
    Location
    GSK Investigational Site
    Ahmedabad, India, 380061
    Status
    Study Complete
    Location
    GSK Investigational Site
    Pune-411 043, India, 411043
    Status
    Study Complete
    Location
    GSK Investigational Site
    Delhi, India, 110060
    Status
    Study Complete

    Study documents

    No study documents available.

    Results overview

    Study Results yet to be posted

    Recruitment status
    Study complete
    Actual primary completion date
    2025-03-06
    Actual study completion date
    2025-14-11

    Plain language summaries

    Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

    Additional information about the trial

    Additional information
    Not applicable
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