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Flucelvax vs Fluzone in children and adolescents
NCT03614975Phase 4
Key facts
- Status
- Completed
- Start
- Sep 2018
- Primary completion
- Dec 2018
- Countries
- 1
- Modality
- Vaccines & Immunotherapeutics
- Drugs
- Fluzone Trivalent
- Conditions
- influenza
01
Overview
Phase 4, randomised, open-label trial of Fluzone Trivalent in influenza (2 arms). Primary endpoint: Seroconversion Response - Change in HI Titers at Day 21. Started Sep 2018; status: completed.
02
Design
2 arms- Study design
- RandomizedOpen-label
Flucelvax Arm
Participants receive 0.5 mL Flucelvax inactivated influenza vaccine intramuscularly.
Fluzone Arm
Participants receive 0.5 mL Fluzone inactivated influenza vaccine intramuscularly.
03
Who it enrols
Healthy children and adolescents aged 4-20 years with available vaccination history, excluding those already vaccinated for the season, immunocompromised, pregnant, or with severe allergies to eggs or flu vaccines.
04
Endpoints
Primary
Seroconversion Response - Change in HI Titers
Secondary
Seroprotection Level
Geometric Mean Titers
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