Last updated: 05/06/2025 05:32:18

Study to assess the immune response, the safety and the reactogenicity of respiratory syncytial virus (RSV) prefusion protein 3 older adult (OA) (RSVPreF3 OA) investigational vaccine when co administered with PCV20 in older adults

GSK study ID
219276
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: A Phase III, Open-label, Randomized, Controlled, Multi-Country Study to Evaluate the Immune Response, Safety and Reactogenicity of RSVPreF3 OA Investigational Vaccine When Co administered with PCV20 in Adults Aged 60\xa0Years and Older
Trial description: The purpose of this study is to assess the ability of RSVPreF3 OA investigational vaccine to generate an immune response when given in combination with PCV20 and its safety in older adults, aged ≥60 years of age.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:

Adjusted geometric mean titers (GMT) of opsonophagocytic (OP) titers at 1 month after the PCV20 vaccination

Timeframe: At Day 31

Adjusted GMTs of respiratory syncytial virus-A (RSV-A) neutralizing titers [estimated dilution 60 (ED60)] at 1 month after the RSVPreF3 OA vaccination

Timeframe: At Day 31 for Co-administration Group and at Day 61 for Control Group

Adjusted GMTs of RSV-B neutralizing titers (ED60) at 1 month after the RSVPreF3 OA vaccination

Timeframe: At Day 31 for Co-administration Group and at Day 61 for Control Group

Secondary outcomes:

Mean geometric increase (MGI) of RSV-A neutralizing titers at 1 month after the RSVPreF3 OA vaccination

Timeframe: At 1 month after the RSVPreF3 OA vaccine dose (Day 31 for Co-administration Group and Day 61 for Control Group) compared to Pre-vaccination (Day 1 for Co-administration Group and Day 31 for Control Group)

MGI of RSV-B neutralizing titers at 1 month after the RSVPreF3 OA vaccination

Timeframe: At 1 month after the RSVPreF3 OA vaccine dose (Day 31 for Co-administration Group and Day 61 for Control Group) compared to Pre-vaccination (Day 1 for Co-administration Group and Day 31 for Control Group)

Number of participants with solicited administration site adverse events (AEs) after each vaccine dose administration

Timeframe: Within 7 days (the day of vaccination and 6 subsequent days) after each vaccine administration (vaccines administered at Day 1 for Co-Administration Group and at Days 1 and 31 for Control group)

Number of participants with solicited systemic AEs after each vaccine dose administration

Timeframe: Within 7 days (the day of vaccination and 6 subsequent days) after each vaccine administration (vaccines administered at Day 1 for Co-Administration Group and at Days 1 and 31 for Control group)

Number of participants with unsolicited AEs

Timeframe: Within 30 days (the day of vaccination and 29 subsequent days) after each vaccine administration (vaccines administered at Day 1 for Co-Administration Group and at Days 1 and 31 for Control group)

Number of participants with SAEs

Timeframe: Throughout the study period (from Day 1 up to 6 months after the last dose administration [last dose given at Day 1 for Co-administration Group and Day 31 for Control Group])

Number of participants with potential immune-mediated diseases (pIMDs)

Timeframe: Throughout the study period (from Day 1 up to 6 months after the last dose administration [last dose given at Day 1 for Co-administration Group and Day 31 for Control Group])

Interventions:
  • Biological/vaccine: RSVPreF3 OA investigational vaccine
  • Biological/vaccine: PCV20
  • Enrollment:
    1113
    Primary completion date:
    2023-06-12
    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)
    May 2023 to May 2024
    Type
    Interventional
    Phase
    3

    Participation criteria

    Sex
    Female & Male
    Age
    60+ years
    Accepts healthy volunteers
    Yes
    • A male or female ≥60 years of age at the time of the first study intervention administration.
    • Participants who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
    • Any confirmed or suspected immunosuppressive or immunodeficient condition resulting from disease or immunosuppressive/cytotoxic therapy, based on medical history and physical examination.
    • History of any reaction or hypersensitivity likely to be exacerbated by the study interventions, in particular any history of severe allergic reaction to any vaccine containing diphtheria toxoid, or pneumococcal polysaccharide 23-valent vaccine (PPSV23).

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Guntersville, AL, United States, 35976
    Status
    Study Complete
    Location
    GSK Investigational Site
    Modesto, CA, United States, 95350
    Status
    Study Complete
    Location
    GSK Investigational Site
    Phoenix, AZ, United States, 85023
    Status
    Study Complete
    Location
    GSK Investigational Site
    Frisco, TX, United States, 75033
    Status
    Study Complete
    Location
    GSK Investigational Site
    West Des Moines, IA, United States, 50266
    Status
    Study Complete
    Location
    GSK Investigational Site
    Antwerpen, Belgium, 2000
    Status
    Study Complete
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    Study documents

    Protocol
    Available language(s): English
    Statistical analysis plan
    Available language(s): English

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Results posted on ClinicalTrials.gov

    Recruitment status
    Study complete
    Actual primary completion date
    2023-06-12
    Actual study completion date
    2024-07-05

    Plain language summaries

    Summary of results in plain language
    Available language(s): English, Dutch (Belgium), French (Belgium), German (Belgium), Polish, Spanish, Spanish (United States)

    To view plain language summaries on trialsummaries.com click here.

    Additional information about the trial

    Additional information
    Not applicable
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