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
Trial overview
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)
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)
- 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.
- 31 May 2024, partial) o 2024/2025 season (01 June 2024
- 31 May 2025) o 2025/2026 season (01 June 2025
- 31 May 2026) o 2026/2027 season (01 June 2026
- 31 May 2027) o 2027/2028 season (01 June 2027
- Age 60 years or older at ARI/LRTD hospital admission date.
- Minimum of 12 months of continuous KPSC membership (allowing for a 31-day gap) prior to the admission date of the ARI/LRTD hospitalization.
- Have RSV test results by reverse transcription polymerase chain reaction (RT-PCR) from 7 days prior to 2 days after ARI/LRTD hospital admission (inclusive of the admission date) among KPSC medical center areas that provide AREXVY. KPSC medical center areas that provide Pfizer RSV vaccine were not included.
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 2028)
- Receipt of AREXVY <=14 days prior to the ARI/LRTD hospital admission date.
- Receipt of RSV monoclonal antibody prior to the ARI/LRTD hospital admission date based on all available medical records.
- Hospitalization 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. Were excluded hospitalizations that tested positive for COVID-19 or influenza as these are vaccine-preventable causes of ARI and risks of these infections may not be independent of RSV vaccination status given that vaccination behaviours tend to be correlated across vaccines.
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.
Trial location(s)
No location data available.
Study documents
No study documents available.
Results overview
No study documents available
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.