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Vaccine Effectiveness of a Bivalent RSV Prefusion F Protein-Based Vaccine for Preventing RSV Hospitalizations in Older Adults

Phase 4
Active, not recruiting
Conditions
RSV
Interventions
Biological: RSV prefusion F protein-based vaccine
Registration Number
NCT06684743
Lead Sponsor
Tor Biering-Sørensen
Brief Summary

The purpose of this pragmatic randomized trial is to evaluate the vaccine effectiveness of bivalent RSV prefusion F vaccine (RSV vaccine) in older adults. Participants will be randomized 1:1 to either RSV vaccine or no RSV vaccine.

Detailed Description

The study is a pragmatic, registry-based, open-label, individually randomized trial. The Danish nationwide administrative health registries will be used for data collection including baseline information, follow-up data, and safety monitoring. The study aims to randomize 130,000 participants. Participants will be individually randomized 1:1 to receive either a bivalent RSV prefusion F vaccine (RSV vaccine) or no RSV vaccine. The trial is designed to assess the vaccine effectiveness of the RSV vaccine vs. no RSV vaccine on RSV-related and all-cause cardio-respiratory outcomes.

Recruitment & Eligibility

Status
ACTIVE_NOT_RECRUITING
Sex
All
Target Recruitment
130000
Inclusion Criteria

Not provided

Exclusion Criteria
  • There are no specific exclusion criteria for this study

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
RSV prefusion F protein-based vaccine (RSV vaccine)RSV prefusion F protein-based vaccineRSV vaccine single injection at day 0
Primary Outcome Measures
NameTimeMethod
Hospitalization for RSV-related respiratory tract disease≥14 days after initially booked vaccination/ information visit date up to 8 months
Secondary Outcome Measures
NameTimeMethod
Hospitalization for RSV-related respiratory tract disease in subsequent seasonsFrom September 1, 2025 up to 9 months (2025/2026 season) and September 1, 2026 up to 9 months (2026/2027 season)

Subsequent seasons (2025/2026 and 2026/2027 RSV seasons)

RSV-related cardio-respiratory hospitalization≥14 days after initially booked vaccination/ information visit date up to 8 months
All-cause cardio-respiratory hospitalization≥14 days after initially booked vaccination/ information visit date up to 8 months
All-cause hospitalization≥14 days after initially booked vaccination/ information visit date up to 8 months
All-cause mortality≥14 days after initially booked vaccination/ information visit date up to 8 months
Hospitalization for RSV-related lower respiratory tract disease≥14 days after initially booked vaccination/ information visit date up to 8 months
RSV-related hospitalization≥14 days after initially booked vaccination/ information visit date up to 8 months
RSV-related respiratory tract disease hospitalization≥14 days after actual vaccination date/ booked information visit date up to 8 months

Primary outcome evaluated among the as-treated study population with balanced follow up time between study arms

All-cause lower respiratory tract disease hospitalization≥14 days after initially booked vaccination/ information visit date up to 8 months
Hospitalization for RSV-related respiratory tract disease by age groups≥14 days after initially booked vaccination/ information visit date up to 8 months

Stratified by age groups (60-74 years and 75+ years)

All-cause respiratory tract disease hospitalization≥14 days after initially booked vaccination/ information visit date up to 8 months

Trial Locations

Locations (2)

Center for Translational Cardiology and Pragmatic Randomized Trials Department of Cardiology Copenhagen University Hospital - Herlev and Gentofte

🇩🇰

Copenhagen, Denmark

Danske Lægers Vaccinations Service

🇩🇰

Søborg, Denmark

Center for Translational Cardiology and Pragmatic Randomized Trials Department of Cardiology Copenhagen University Hospital - Herlev and Gentofte
🇩🇰Copenhagen, Denmark

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