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Extension Study of Influenza Vaccines in Children (V70P2E1)
NCT00644540Phase 2
Key facts
- Status
- Completed
- Start
- Nov 2007
- Primary completion
- Jan 2008
- Countries
- 1
- Sponsor
- Novartis
- Modality
- Vaccines & Immunotherapeutics
- Conditions
- influenza
01
Overview
Phase 2, single-blind trial of influenza vaccine (surface antigen, inactivated, adjuvanted) in influenza (2 arms), sponsored by Novartis. Primary endpoint: Geometric Mean Titers at 181 days. Started Nov 2007; status: completed.
02
Design
2 arms- Study design
- Non-randomizedSingle-blind
Fluad Group
Subjects who received Fluad in V70P2 receive a single dose of Fluad.
Comparator Group
Subjects who received Vaxigrip in V70P2 receive a single dose of Vaxigrip.
03
Who it enrols
Healthy children up to 48 months of age who received both doses of one of the two study vaccines in the previous V70P2 trial.
04
Endpoints
Primary
Geometric Mean Titers
Secondary
Seroprotection Rate
Seroconversion Rate
Safety and Tolerability
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