Last updated: 08/14/2025 04:00:42

Respiratory Syncytial Virus Vaccine Effectiveness in Older Adults

GSK study ID
300153
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: Respiratory Syncytial Virus Vaccine Effectiveness in Older Adults
Trial description: The purpose of this study is to estimate the effectiveness of AREXVY (adjuvanted RSVPreF3) vaccination in preventing respiratory syncytial virus (RSV)-related hospitalizations and other RSV-related outcomes among adults aged greater than or equal to (>=) 60 years during the 2023-2024 RSV season.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Effectiveness of AREXVY vaccination against RSV-related hospitalization among adults aged ≥60 years

Timeframe: August 2023 to May 2024

Secondary outcomes:

Effectiveness of AREXVY vaccination against RSV-related hospitalization among adults aged ≥60 years in subgroups of interest

Timeframe: August 2023 to May 2024

Effectiveness of AREXVY vaccination against RSV-related hospitalization involving mechanical ventilation, extracorporeal membrane oxygenation (ECMO), intensive care unit (ICU) admission, or death among adults aged ≥60 years

Timeframe: August 2023 to May 2024

Interventions:
Not applicable
Enrollment:
Not applicable
Primary completion date:
2025-15-10
Observational study model:
Cohort
Time perspective:
Retrospective
Clinical publications:
Not applicable
Medical condition
Respiratory Syncytial Virus Infections
Product
Not applicable
Collaborators
Optum Research, RTI Health Solutions
Study date(s)
August 2025 to October 2025
Type
Observational
Phase
Not applicable

Participation criteria

Sex
Female & Male
Age
60+ years
Accepts healthy volunteers
Yes
  • Age >=60 years as of 2023; exact date of birth is not available in the data source.
  • Assignment criteria are met for vaccinated or unvaccinated groups. The individuals will be categorized into groups based on vaccination status at the index date following 01 Aug 2023. The individuals may be in the unvaccinated group prior to becoming vaccinated and indexing into a vaccinated group.
  • Unknown age, sex, insurance type, or state.
  • >=1 medical or pharmacy claim with a code for Abrysvo, AREXVY, nirsevimab, or palivizumab during the baseline period.

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
Will be recruiting
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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