Last updated: 12/23/2025 10:50:12
Respiratory syncytial virus vaccine effectiveness in older adults: a two-year analysis
GSK study ID
308530
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: a two-year analysis
Trial description: The purpose of this study is to estimate the effectiveness of Arexvy vaccination in preventing respiratory syncytial virus (RSV)-related hospitalizations and other RSV-related outcomes among adults aged ≥60 years. The analysis will use administrative claims data from the Optum Research Database (ORD) for the study period of 01 August 2022 through 31 May 2025.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Effectiveness of the Arexvy vaccination against RSV-related hospitalization among adults aged ≥60 years
Timeframe: From 14 days after the index date to disenrollment, death, vaccination with Abrysvo, Arexvy or mRESVIA, or end of study (31 May 2025), whichever occurs first
Secondary outcomes:
Effectiveness of the Arexvy vaccination against RSV-related hospitalization among adults aged ≥60 years by time since vaccination and by timing of vaccination
Timeframe: From 14 days after the index date to disenrollment, death, vaccination with Abrysvo, Arexvy or mRESVIA, or end of study (31 May 2025), whichever occurs first
Effectiveness of the Arexvy vaccination against RSV-related hospitalization among adults aged ≥60 years in key subgroups (e.g., aged ≥80 years, immunocompromised, with comorbid cardiovascular or pulmonary disease, with comorbid diabetes)
Timeframe: From 14 days after the index date to disenrollment, death, vaccination with Abrysvo, Arexvy or mRESVIA, or end of study (31 May 2025), whichever occurs first
Effectiveness of the 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: From 14 days after the index date to disenrollment, death, vaccination with Abrysvo, Arexvy or mRESVIA, or end of study (31 May 2025), whichever occurs first
Interventions:
Not applicable
Enrollment:
Not applicable
Primary completion date:
2026-26-06
Observational study model:
Cohort
Time perspective:
Retrospective
Clinical publications:
Not applicable
Medical condition
Respiratory Syncytial Virus Infections
Product
Not applicable
Collaborators
Not applicable
Study date(s)
January 2026 to June 2026
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
60+ years
Accepts healthy volunteers
No
- Age ≥60 years as of the index date;
- Meets assignment criteria for vaccinated or unvaccinated groups.
- Unknown age, sex, insurance type, or state.
- ≥1 medical or pharmacy claim with a code for Abrysvo, Arexvy, or mRESVIA prior to the index date; all data since 21 June 2023 will be used to assess prior RSV vaccination.
Inclusion and exclusion criteria
Inclusion criteria:
- Age ≥60 years as of the index date;
- Meets assignment criteria for vaccinated or unvaccinated groups. Patients 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 patient identification period, with no prior claim with a code for Abrysvo or mRESVIA vaccination during the patient identification period. The index date will be defined as the first date with a claim for Arexvy.
- Multiple claims for Arexvy on the index date through 3 days following the index date will be considered duplicates. Claims for Arexvy, Abrysvo, or mRESVIA ≥4 days after index will be considered censoring events, in order to isolate the effectiveness of the first dose of Arexvy received. While expected to be rare, the proportion of patients with claims for Abrysvo within 3 days after Arexvy will be reported.
- Unvaccinated against RSV: Matched to a patient in the vaccinated group. The index date will be assigned to the same date as the matched vaccinated patient’s index date.
- Continuously enrolled with medical and pharmacy benefits since 21 June 2023 or for at least 12 months prior to and not including the index date, whichever is longer, and for at least 14 days after the index date. Administrative gaps of up to 32 days will be permitted between enrollment periods, and enrollment periods will be bridged over these gaps.
- The baseline period will be defined as the 12 months prior to and not including the index date.
Exclusion criteria:
- Unknown age, sex, insurance type, or state.
- ≥1 medical or pharmacy claim with a code for Abrysvo, Arexvy, or mRESVIA prior to the index date; all data since 21 June 2023 will be used to assess prior RSV vaccination.
- ≥1 medical or pharmacy claim with a code for nirsevimab, palivizumab, or clesrovimab 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 or mRESVIA on the index date through 3 days following the index date (Index to Index+3); these patients will be excluded due to concerns that these claims may indicate errors in either the Arexvy, mRESVIA, or Abrysvo claim and lead to a risk of exposure misclassification.
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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