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
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
- 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.
Inclusion and exclusion criteria
Inclusion criteria:
- 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.
- Vaccinated: A medical or pharmacy claim with a NDC or CPT code for AREXVY vaccination during the identification period, with no prior claim with a code for Abrysvo vaccination during the identification period. The index date will be defined as the first date with a claim for AREXVY. o Multiple claims for AREXVY on the index date through 3 days following the index date (Index to Index+3) will be considered duplicates. Claims for AREXVY or Abrysvo >=4 days after index (Index+4 to Index+n) will be considered censoring events, in order to isolate the effectiveness of the first dose of AREXVY received.
- Continuously enrolled with medical and pharmacy benefits for at least 12 months prior to and not including the index date (baseline period) and for at least 14 days after the index date.
Age >=60 years as of 2023; exact date of birth is not available in the data source.
Unvaccinated against RSV: Matched to an *individual in the vaccinated group. The index date will be assigned to the same date as the matched vaccinated individual‘s index date.
Exclusion criteria:
- >=1 medical or pharmacy claim with a code for Abrysvo, AREXVY, nirsevimab, or palivizumab during the baseline period. ≥1 medical claim with a diagnosis code for RSV in the 90 days prior to the index date.
- (Vaccinated group only) >=1 medical or pharmacy claim with a code for Abrysvo on the index date through 3 days following the index date (Index to Index+3); these individuals will be excluded due to concerns that these claims may indicate errors in either the AREXVY or Abrysvo claim and lead to a risk of exposure misclassification.
Unknown age, sex, insurance type, or state.
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
Participate in clinical trial
Access to clinical trial data by researchers
Visit website