Last updated: 10/21/2025 09:10:11

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

GSK study ID
223372
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Will be recruiting
Will be recruiting
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: A Phase 3, Randomized, Controlled, Observer blind, Immuno-bridging Study to Evaluate Immunogenicity, Reactogenicity, Safety of a Single Dose of GSK’s RSVPreF3 OA Investigational Vaccine in Chinese Adults 18-59 Years of Age at Increased Risk of Respiratory Syncytial Virus Disease
Trial description: The study will evaluate the immune response of the RSVPreF3 OA investigational vaccine in Chinese adults 18 to 59 years of age (YOA) who are at increased risk of respiratory syncytial virus (RSV) disease, in comparison with the immune response generated in older adults 60 YOA and above from the 219815 (RSV OA=ADJ-021; NCT06551181) study following a single dose of the RSVPreF3 OA vaccine. In addition, the safety and reactogenicity of the vaccine will also be assessed.
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 group Geometric Mean Titers (GMTs)

Timeframe: At Day 31 (i.e., 1 month after RSVPreF3 OA investigational vaccine administration)

RSV-A neutralizing titers expressed as group Seroresponse rate (SRR)

Timeframe: At Day 31 (i.e., 1 month after RSVPreF3 OA investigational vaccine administration)

RSV-B neutralizing titers expressed as group GMTs

Timeframe: At Day 31 (i.e., 1 month after RSVPreF3 OA investigational vaccine administration)

RSV-B neutralizing titers expressed as group SRR

Timeframe: At Day 31 (i.e., 1 month after RSVPreF3 OA investigational vaccine administration)

Secondary outcomes:

RSV-A and RSV-B neutralizing titers expressed as group GMTs

Timeframe: At Day 31 and at Month 6 (i.e., 1 month and 6 months after RSVPreF3 OA investigational vaccine administration)

RSV-A and RSV-B neutralizing titers expressed as group SRR

Timeframe: At Day 31 and at Month 6 (i.e., 1 month and 6 months after RSVPreF3 OA investigational vaccine administration)

Number of participants with RT-PCR-confirmed RSV A and/or B-associated acute respiratory illness (ARI) and lower respiratory tract disease (LRTD), assessed for all groups of the current study

Timeframe: Day 1 to Month 6 of the current study

Duration of RT-PCR-confirmed RSV A and/or B-associated ARI and LRTD episodes, assessed for all the groups of the current study

Timeframe: Day 1 to Month 6 of the current study

Number of participants reporting symptoms/signs of RT-PCR-confirmed RSV A and/or B-associated ARI and LRTD, assessed for all the groups of the current study

Timeframe: Day 1 to Month 6 of the current study

Number of participants with RT-PCR-confirmed RSV A and/or B-associated ARI and LRTD by severity, assessed for all the groups of the current study

Timeframe: Day 1 to Month 6 of the current study

Number of participants with RT-PCR-confirmed RSV A and/or B-associated ARI and LRTD by frailty status, assessed for all the groups of the current study

Timeframe: Day 1 to Month 6 of the current study

Number of participants with each solicited administration site event assessed for all the groups of the current study

Timeframe: Day 1 to Day 7 of the current study

Number of participants with each solicited systemic event assessed for all the groups of the current study

Timeframe: Day 1 to Day 7 of the current study

Number of participants with unsolicited adverse events (AEs) assessed for all the groups of the current study

Timeframe: Day 1 to Day 30 of the current study

Number of participants with serious adverse events (SAEs) assessed for all the groups of the current study

Timeframe: Day 1 up to study end (Month 6) of the current study

Number of participants with potential immune-mediated disease (pIMDs) assessed for all the groups of the current study

Timeframe: Day 1 up to study end (Month 6) of the current study

Interventions:
  • Biological/vaccine: RSVPreF3 OA vaccine
  • Biological/vaccine: Placebo
  • Enrollment:
    750
    Primary completion date:
    2026-16-07
    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 2025 to December 2026
    Type
    Interventional
    Phase
    3

    Participation criteria

    Sex
    Female & Male
    Age
    18 - 59 Years
    Accepts healthy volunteers
    No
    • 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
    • Any confirmed or suspected immunosuppressive or immunodeficient condition resulting from disease or immunosuppressive/cytotoxic therapy, based on medical history and physical examination.

    Trial location(s)

    This study does not involve prospective enrollment of participants.

    Study documents

    No study documents available.

    Results overview

    Study Results yet to be posted

    Recruitment status
    Will be recruiting
    Actual primary completion date
    Not applicable
    Actual study completion date
    Not applicable

    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
    Participate in clinical trial
    Access to clinical trial data by researchers
    Visit website