Clinical trial NCT06684743: Vaccine Effectiveness of a Bivalent RSV Prefusion F Protein-Based Vaccine for Preventing RSV Hospitalizations in Older Adults
Official title: A Pragmatic Randomized Trial to Evaluate the Vaccine Effectiveness of Abrysvo® for Preventing RSV Hospitalizations in Adults Aged 60 Years or Above
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE4
Conditions: RSV
Keywords: RSV
Vaccination
Pragmatic
Registry
Lower respiratory tract disease
Respiratory tract disease
Respiratory
Cardiovascular
Lead sponsor: Herlev and Gentofte Hospital
Sponsor class: OTHER
Collaborators: name: Pfizer
First posted: 2024-11-12
Enrollment: 130000
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria

* Age 60 years and above
* Informed consent form has been signed and dated

Exclusion Criteria:

* There are no specific exclusion criteria for this study

Primary outcomes:
measure: Hospitalization for RSV-related respiratory tract disease
timeFrame: ≥14 days after initially booked vaccination/ information visit date up to 8 months
Secondary outcomes:
measure: RSV-related respiratory tract disease hospitalization
timeFrame: ≥14 days after actual vaccination date/ booked information visit date up to 8 months
measure: Hospitalization for RSV-related lower respiratory tract disease
timeFrame: ≥14 days after initially booked vaccination/ information visit date up to 8 months
measure: Hospitalization for RSV-related respiratory tract disease by age groups
timeFrame: ≥14 days after initially booked vaccination/ information visit date up to 8 months
measure: Hospitalization for RSV-related respiratory tract disease in subsequent seasons
timeFrame: From September 1, 2025 up to 9 months (2025/2026 season) and September 1, 2026 up to 9 months (2026/2027 season)
measure: RSV-related hospitalization
timeFrame: ≥14 days after initially booked vaccination/ information visit date up to 8 months
measure: All-cause respiratory tract disease hospitalization
timeFrame: ≥14 days after initially booked vaccination/ information visit date up to 8 months
measure: RSV-related cardio-respiratory hospitalization
timeFrame: ≥14 days after initially booked vaccination/ information visit date up to 8 months
measure: All-cause cardio-respiratory hospitalization
timeFrame: ≥14 days after initially booked vaccination/ information visit date up to 8 months
measure: All-cause lower respiratory tract disease hospitalization
timeFrame: ≥14 days after initially booked vaccination/ information visit date up to 8 months
measure: All-cause hospitalization
timeFrame: ≥14 days after initially booked vaccination/ information visit date up to 8 months
measure: All-cause mortality
timeFrame: ≥14 days after initially booked vaccination/ information visit date up to 8 months
Other outcomes:
measure: Hospitalization for RSV-related respiratory tract disease stratified by RSV type
timeFrame: ≥14 days after initially booked vaccination/ information visit date up to 8 months
measure: Total length of hospital stays due to respiratory tract infection with RSV infection
timeFrame: ≥14 days after initially booked vaccination/ information visit date up to 8 months
measure: RSV or pneumonia hospitalization [composite endpoint]
timeFrame: ≥14 days after initially booked vaccination/ information visit date up to 8 months
measure: Pneumonia hospitalization
timeFrame: ≥14 days after initially booked vaccination/ information visit date up to 8 months
measure: Any hospitalization with RSV infection
timeFrame: ≥14 days after initially booked vaccination/ information visit date up to 8 months
measure: Cardiovascular disease hospitalization
timeFrame: ≥14 days after initially booked vaccination/ information visit date up to 8 months
measure: Hospitalization requiring mechanical ventilation
timeFrame: ≥14 days after initially booked vaccination/ information visit date up to 8 months
measure: Intensive care unit hospitalization
timeFrame: ≥14 days after initially booked vaccination/ information visit date up to 8 months
measure: Myocardial infarction hospitalization
timeFrame: ≥14 days after initially booked vaccination/ information visit date up to 8 months
measure: Heart failure hospitalization
timeFrame: ≥14 days after initially booked vaccination/ information visit date up to 8 months
measure: Stroke hospitalization
timeFrame: ≥14 days after initially booked vaccination/ information visit date up to 8 months
measure: Influenza hospitalization
timeFrame: ≥14 days after initially booked vaccination/ information visit date up to 8 months
measure: COVID-19 hospitalization
timeFrame: ≥14 days after initially booked vaccination/ information visit date up to 8 months
measure: Hospitalization for pneumococcal disease
timeFrame: ≥14 days after initially booked vaccination/ information visit date up to 8 months
measure: Any infectious disease hospitalization
timeFrame: ≥14 days after initially booked vaccination/ information visit date up to 8 months
measure: MACE (composite endpoint)
timeFrame: ≥14 days after initially booked vaccination/ information visit date up to 8 months
measure: Laboratory-confirmed RSV infection
timeFrame: ≥14 days after initially booked vaccination/ information visit date up to 8 months
measure: Laboratory-confirmed influenza infection
timeFrame: ≥14 days after initially booked vaccination/ information visit date up to 8 months
measure: Laboratory-confirmed pneumococcal infection
timeFrame: ≥14 days after initially booked vaccination/ information visit date up to 8 months
measure: Laboratory-confirmed COVID-19 infection
timeFrame: ≥14 days after initially booked vaccination/ information visit date up to 8 months
measure: Cardio-respiratory mortality
timeFrame: ≥14 days after initially booked vaccination/ information visit date up to 8 months
measure: Respiratory mortality
timeFrame: ≥14 days after initially booked vaccination/ information visit date up to 8 months
measure: Cardiovascular mortality
timeFrame: ≥14 days after initially booked vaccination/ information visit date up to 8 months
measure: In-hospital mortality
timeFrame: ≥14 days after initially booked vaccination/ information visit date up to 8 months
measure: 30-day mortality following hospital discharge for primary endpoint
timeFrame: ≥14 days after initially booked vaccination/ information visit date up to 8 months
measure: Hospitalization for RSV-related lower respiratory tract disease in subsequent 2025/2026 and 2026/2027 RSV seasons
timeFrame: From September 1, 2025 up to 9 months (2025/2026 season) and September 1, 2026 up to 9 months (2026/2027 season)
measure: RSV-related respiratory tract disease hospitalization by chronic obstructive pulmonary disease status
timeFrame: ≥14 days after initially booked vaccination/ information visit date up to 8 months
measure: New-onset dementia
timeFrame: ≥14 days after initially booked vaccination/ information visit date up to 10 years
measure: RSV-related respiratory tract disease hospitalization by immunocompromised status
timeFrame: ≥14 days after initially booked vaccination/ information visit date up to 8 months
measure: RSV-related lower respiratory tract disease hospitalization by immunocompromised status
timeFrame: ≥14 days after initially booked vaccination/ information visit date up to 8 months
measure: All-cause respiratory tract disease hospitalization by immunocompromised status
timeFrame: ≥14 days after initially booked vaccination/ information visit date up to 8 months
measure: All-cause lower respiratory tract disease hospitalization by immunocompromised status
timeFrame: ≥14 days after initially booked vaccination/ information visit date up to 8 months
measure: RSV-related respiratory tract disease hospitalization by severe immunocompromised status
timeFrame: ≥14 days after initially booked vaccination/ information visit date up to 8 months
measure: All-cause respiratory tract disease hospitalization by severe immunocompromised status
timeFrame: ≥14 days after initially booked vaccination/ information visit date up to 8 months
measure: Atrial fibrillation hospitalization
timeFrame: ≥14 days after initially booked vaccination/ information visit date up to 8 months
measure: Hospitalization for any cardiac arrythmia
timeFrame: ≥14 days after initially booked vaccination/ information visit date up to 8 months
measure: Hospitalization for pericarditis
timeFrame: ≥14 days after initially booked vaccination/ information visit date up to 8 months
measure: Hospitalization for myocarditis
timeFrame: ≥14 days after initially booked vaccination/ information visit date up to 8 months
measure: Asthma exacerbation hospitalization
timeFrame: ≥14 days after initially booked vaccination/ information visit date up to 8 months
measure: RSV-related respiratory tract disease hospitalization by hepatic or renal impairment status
timeFrame: ≥14 days after initially booked vaccination/ information visit date up to 8 months
Locations:
city: Copenhagen
country: Denmark
facility: Center for Translational Cardiology and Pragmatic Randomized Trials Department of Cardiology Copenhagen University Hospital - Herlev and Gentofte
city: Søborg
country: Denmark
facility: Danske Lægers Vaccinations Service
Study officials:
affiliation: Center for Translational Cardiology and Pragmatic Randomized Trials, Department of Cardiology, Copenhagen University Hospital - Herlev and Gentofte
name: Tor Biering-Sørensen, MD, PhD, MSc, MPH
role: STUDY_CHAIR
References: