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Immunogenicity and Safety of Shenzhen Trivalent Influenza Vaccine (Shz-IIV3)
NCT02228980Phase 4
Key facts
- Status
- Completed
- Start
- Sep 2014
- Primary completion
- Dec 2014
- Countries
- 1
- Sponsor
- Sanofi
- Modality
- Vaccines & Immunotherapeutics
- Drugs
- influenza vaccine
- Conditions
- influenza
01
Overview
Phase 4, open-label trial of influenza vaccine in influenza (4 arms), sponsored by Sanofi. Primary endpoint: Geometric Mean Titers of Influenza Antibodies at Day 56. Started Sep 2014; status: completed.
02
Design
4 arms- Study design
- Non-randomizedOpen-label
Subjects aged 6 to 35 months
2 doses of 0.25 mL SP Shz TIV given 28 days apart
Subjects aged 3 to 17 years
Single dose of 0.5 mL SP Shz TIV
Subjects aged 18 to 60 years
Single dose of 0.5 mL SP Shz TIV
Subjects aged 61 years or older
Single dose of 0.5 mL SP Shz TIV
03
Who it enrols
Healthy subjects aged 6 months and older. Children 3-8 years must have prior influenza vaccination or exposure history. Children 6-35 months excluded if previously vaccinated with 2 doses.
04
Endpoints
Primary
Geometric Mean Titers of Influenza Antibodies
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