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FLUO: High-Dose vs Standard Influenza Vaccine in Obese Adults
NCT05409612Phase 3
Key facts
- Status
- Completed
- Start
- Nov 2022
- Primary completion
- Apr 2023
- Countries
- 1
- Sponsor
- Assistance publique - Hôpitaux de Paris
- Modality
- Vaccines & Immunotherapeutics
- Conditions
- influenza
01
Overview
Phase 3, randomised, open-label trial of Quadrivalent recombinant influenza vaccine in influenza (2 arms), sponsored by Assistance publique - Hôpitaux de Paris. Primary endpoint: Ratio of Geometric Mean Titers at 1 month. Started Nov 2022; status: completed.
02
Design
2 arms- Study design
- RandomizedOpen-label
Supemtek
Recombinant high-dose quadrivalent influenza vaccine (RIV4)
Vaxigriptetra
Standard dose quadrivalent inactivated influenza vaccine (SD)
03
Who it enrols
Adults aged 18-75 with severe obesity (BMI >= 35 kg/m2), excluding those with recent influenza vaccination/infection, immunodeficiency, or history of bariatric surgery within 2 years.
04
Endpoints
Primary
Ratio of Geometric Mean Titers
Secondary
Seroconversion Rate
Seroconversion Factor (Geometric Mean Fold Increase)
Seroprotection Rate
Geometric Mean Titers
Solicited Reactogenicity and Adverse Events
Proven Influenza Cases
05
Results
Not all primary endpoints met
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