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

Tor Biering-Sørensen

Status and phase: Active, not recruiting; Phase 4

Conditions: RSV

Treatments: Biological: RSV prefusion F protein-based vaccine

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06684743

DAN-RSV

2024-516600-42-00 (EU Trial (CTIS) Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 130,000 estimated patients

Sex: All

Ages: 60+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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130,000 participants in 2 patient groups

RSV prefusion F protein-based vaccine (RSV vaccine)

Experimental group

Description:

RSV vaccine single injection at day 0

Treatment:

Biological: RSV prefusion F protein-based vaccine

No RSV vaccine (control)

No Intervention group

Description:

Control arm, no RSV vaccine