Last updated: 10/19/2026 06:40:14

A study to evaluate the durability of protection of AREXVY in preventing respiratory syncytial virus (RSV)-associated lower respiratory tract disease (LRTD) hospitalization in adults 60 years of age (YOA) and older

GSK study ID
308536
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Planned
Planned
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: Non-Interventional Study to Estimate the Durability of Protection of AREXVY in Preventing Respiratory Syncytial Virus-Associated Lower Respiratory Tract Disease Hospitalization in Adults >=60 Years
Trial description: The purpose of the study is to evaluate vaccine effectiveness (VE) of AREXVY in preventing laboratory confirmed RSV-LRTD-associated hospitalisation in adults >=60 years of age (YOA) during a 5-year period post-vaccination.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

VE of AREXVY in preventing laboratory-confirmed RSV-LRTD hospitalization

Timeframe: During study period: Dec 2023 – May 2027 (season 4) or May 2028 (season 5)

Secondary outcomes:

VE of AREXVY in preventing laboratory-confirmed RSV-acute respiratory infection (ARI) hospitalization and, as a subset, RSV-LRTD hospitalization, by time since vaccination, if sample size allows

Timeframe: From 15 days post vaccination to up to 5 years post-vaccination

VE of AREXVY in preventing laboratory-confirmed RSV-ARI hospitalization and, as a subset, RSV-LRTD hospitalization, in overall population and in non-immunocompromised adults separately, stratified by demographic and clinical criteria, if sample size allows

Timeframe: From 15 days post vaccination to up to 5 years post-vaccination

VE of AREXVY in preventing laboratory-confirmed RSV-ARI hospitalization and, as a subset, RSV-LRTD hospitalization, in immunocompromised adults, by time since vaccination, if sample size allows

Timeframe: From 15 days post vaccination to up to 5 years post-vaccination

VE of AREXVY in preventing more severe laboratory-confirmed RSV-ARI hospitalization and, as a subset, RSV-LRTD hospitalization outcomes, by time since vaccination, if sample size allows

Timeframe: From 15 days post vaccination to up to 5 years post-vaccination

VE of AREXVY in preventing laboratory-confirmed RSV-related mortality during hospitalization, by time since vaccination, if sample size allows

Timeframe: From 15 days post vaccination to up to 5 years post-vaccination

Description of the outcomes of RSV-ARI and, as a subset, RSV-LRTD during hospitalization

Timeframe: During study period: Dec 2023 – May 2027 (season 4) or May 2028 (season 5)

Interventions:
Not applicable
Enrollment:
Not applicable
Primary completion date:
2029-01-03
Observational study model:
Other
Time perspective:
Retrospective
Clinical publications:
Not applicable
Medical condition
Respiratory Syncytial Virus Infections
Product
RSVPreF3
Collaborators
Kaiser Permanente Southern California (KPSC)
Study date(s)
October 2026 to March 2029
Type
Observational
Phase
Not applicable

Participation criteria

Sex
Female & Male
Age
60+ years
Accepts healthy volunteers
Yes
  • Admitted to hospital with at least one LRTD or ARI International Classification of Diseases, 10th Revision (ICD-10) code during the pre-defined RSV seasons. RSV seasons are defined below:
  • o 2023/2024 season (01 December 2023 - 31 May 2024, partial)
  • Receipt of an RSV vaccine other than AREXVY or receipt of more than 1 dose of any RSV vaccine prior to the ARI/LRTD hospitalization admission date.
  • Receipt of AREXVY <=14 days prior to the ARI/LRTD hospital admission date.

Trial location(s)

No location data available.

Study documents

No study documents available.

Results overview

No study documents available

Recruitment status
Planned
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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