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Influenza vaccine effectiveness in pregnant women and children (FluEffect)
NCT04998344Phase 4
Key facts
- Status
- Active, not recruiting
- Start
- Apr 2021
- Primary completion
- Dec 2024
- Countries
- 2
- Sponsor
- University of Bergen
- Modality
- Vaccines & Immunotherapeutics
- Drugs
- Fluzone Trivalent
- Conditions
- influenza
01
Overview
Phase 4, randomised, open-label trial of Fluzone Trivalent in influenza, sponsored by University of Bergen. Primary endpoint: Effectiveness of influenza vaccination in reducing rates of acute respiratory infections due to laboratory-confirmed influenza at 3 years. Started Apr 2021; status: active, not recruiting.
02
Design
- Study design
- RandomizedOpen-label
03
Who it enrols
Healthy pregnant women (28-34 weeks gestation) and children (6-59 months) residing in selected villages in Matlab, Bangladesh.
04
Endpoints
Primary
Effectiveness of influenza vaccination in reducing rates of acute respiratory infections due to laboratory-confirmed influenza
Secondary
Safety of influenza vaccine
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