Last updated: 10/10/2025 16:20:08

Study to evaluate effectiveness of adjuvanted RSVPreF3 (Arexvy) vaccine against RSV-associated hospitalisations among older adults in Germany

GSK study ID
300137
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: Effectiveness of adjuvanted RSVPreF3 (Arexvy) vaccine against RSV-associated hospitalisations among older adults in Germany – a test-negative case-control study
Trial description: This study aims to estimate the real-world vaccine effectiveness (VE) of Arexvy in Germany against RSV-related hospitalization in the population recommended for RSV vaccination by the Standing Committee on Vaccination (STIKO).
Primary purpose:
Prevention
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Number of hospitalizations due to laboratory-confirmed RSV infection in participants with Lower respiratory tract disease (LRTD) 60 to 74 years at increased risk of severe RSV disease or 75 years or older, within the first season after vaccination

Timeframe: Two RSV seasons: 01 October 2025 to 30 April 2026 (RSV Season 1, 2025/26) and 01 October 2026 to 30 April 2027 (RSV Season 2, 2026/27).

Secondary outcomes:

Number of hospitalizations due to laboratory-confirmed RSV infection in participants with Acute respiratory infection (ARI) 60 to 74 years at increased risk of severe RSV disease or 75 years or older, within the first season after vaccination.

Timeframe: Two RSV seasons: 01 October 2025 to 30 April 2026 (RSV Season 1, 2025/26) and 01 October 2026 to 30 April 2027 (RSV Season 2, 2026/27).

Interventions:
Not applicable
Enrollment:
Not applicable
Primary completion date:
2027-30-06
Observational study model:
Case-Control
Time perspective:
Prospective
Clinical publications:
Not applicable
Medical condition
Respiratory Syncytial Virus Infections
Product
Not applicable
Collaborators
P95 BV
Study date(s)
October 2025 to June 2027
Type
Observational
Phase
Not applicable

Participation criteria

Sex
Female & Male
Age
60+ years
Accepts healthy volunteers
No
  • The participant is hospitalized with LRTD/ARI for at least one day (the dates of admission and discharge differ by at least one day). • The participant is aged 60 to 74 years, with at least one chronic condition as a risk factor for severe RSV, or aged 75 years or older.
  • Informed consent is obtained from the participant or, when accepted by the Ethics Committee, from the participant’s legally acceptable representative(s) prior to enrollment.
  • The participant tests negative for RSV but positive for influenza and/or SARS-CoV-2 on a PCR test using the routine respiratory specimen.
  • The participant has been previously enrolled in the study during any prior hospitalization episode.
Inclusion and exclusion criteria
Inclusion criteria:

    The participant is hospitalized with LRTD/ARI for at least one day (the dates of admission and discharge differ by at least one day).

    • The participant is aged 60 to 74 years, with at least one chronic condition as a risk factor for severe RSV, or aged 75 years or older.
  • Informed consent is obtained from the participant or, when accepted by the Ethics Committee, from the participant’s legally acceptable representative(s) prior to enrollment.
  • A PCR test (used as standard of care in the hospital) result is obtained from the participant within 10 days prior to or up to 72 hours after hospital admission. Antigen testing will not be used for eligibility.
Exclusion criteria:
  • The participant tests negative for RSV but positive for influenza and/or SARS-CoV-2 on a PCR test using the routine respiratory specimen.
  • The participant has been previously enrolled in the study during any prior hospitalization episode.
  • The participant has been transferred to the study hospital from another inpatient healthcare facility.

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