Last updated: 03/07/2025 09:51:08

Non-interventional study to estimate the effectiveness of Arexvy vaccine in preventing respiratory syncytial virus (RSV)-associated lower respiratory tract disease (LRTD) hospitalization in adults 60 years and older

GSK study ID
222072
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Recruitment complete
Recruitment complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: Non-interventional study to estimate the effectiveness of Arexvy vaccine in preventing respiratory syncytial virus-associated lower respiratory tract disease hospitalization in adults 60 years and older: a test-negative design
Trial description: This study will evaluate the vaccine effectiveness of Arexvy in preventing laboratory-confirmed RSV-LRTD-associated hospitalization in adults 60 years and older using a test-negative study design.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Laboratory-confirmed RSV-LRTD hospitalizations in non-immunocompromised adult population

Timeframe: Study period (December 2023 – May 2026)

Secondary outcomes:

Laboratory-confirmed RSV-Acute Respiratory Infection (ARI) and RSV-LRTD hospitalizations stratified by protocol assessed variables in overall and non-immunocompromised adult populations, separately

Timeframe: Study period (December 2023 – May 2026)

Number of RSV-ARI and RSV-LRTD related mortality during hospitalization, in overall and non-immunocompromised adult population, separately

Timeframe: Study period (December 2023 – May 2026)

Complications and health care resource use of RSV-ARI and RSV-LRTD during hospitalization, in overall and non-immunocompromised adult population, separately

Timeframe: Study period (December 2023 – May 2026)

Mortality and health care utilization after RSV-LRTD and RSV-ARI hospitalization, in overall and non-immunocompromised adult population, separately

Timeframe: Within 30- and 180-days post discharge after RSV-LRTD hospitalization

Laboratory-confirmed RSV-LRTD and RSV-ARI hospitalizations, stratified by time since vaccination, in overall and non-immunocompromised adult population, separately

Timeframe: Study period (December 2023 – May 2026)

Interventions:
Not applicable
Enrollment:
532
Primary completion date:
2027-30-06
Observational study model:
Other
Time perspective:
Retrospective
Clinical publications:
Not applicable
Medical condition
Respiratory Syncytial Virus Infections
Product
Not applicable
Collaborators
Kaiser Permanente Southern California
Study date(s)
March 2025 to September 2027
Type
Observational
Phase
Not applicable

Participation criteria

Sex
Female & Male
Age
60+ years
Accepts healthy volunteers
No
  • Admitted to hospital with LRTD or ARI during the pre-defined RSV seasons.
  • Age 60 years or older at ARI/LRTD hospital admission date.
  • Receipt of an RSV vaccine other than Arexvy or receipt of more than 1 dose of RSV vaccine prior to the ARI/LRTD hospitalization admission date.
  • Receipt of an Arexvy vaccine less than or equal to (<=) 14 days prior to the ARI/LRTD hospital admission date.
Inclusion and exclusion criteria
Inclusion criteria:

    Admitted to hospital with LRTD or ARI during the pre-defined RSV seasons.

    • Age 60 years or older at ARI/LRTD hospital admission date.
    • Minimum of 12 months of continuous Kaiser Permanente Southern California (KPSC) membership (allowing for a 31-day gap) prior to the ARI/LRTD hospital admission date.
    • Have RSV test results by RT-PCR from 7 days prior to 2 days after ARI/LRTD hospital admission (inclusive of the admission date).
Exclusion criteria:

    Receipt of an RSV vaccine other than Arexvy or receipt of more than 1 dose of RSV vaccine prior to the ARI/LRTD hospitalization admission date.

    • Receipt of an Arexvy vaccine less than or equal to (<=) 14 days prior to the ARI/LRTD hospital admission date.
    • Receipt of RSV monoclonal antibody prior to the ARI/LRTD hospital admission date.
    • Individuals with a positive COVID-19 or influenza RT-PCR test from 7 days prior to 2 days after the ARI/LRTD admission date with an RSV test result.

Trial location(s)

This study does not involve prospective enrollment of participants.

Study documents

No study documents available.

Results overview

No study documents available

Recruitment status
Recruitment complete
Actual primary completion date
Not applicable
Actual study completion date
Not applicable

Plain language summaries

Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.

Additional information about the trial

Not applicable
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