Study of Inactivated, Split-Virion Influenza Vaccine Administered by Intradermal Route Versus Vaxigrip® in Adults
- Conditions
- InfluenzaOrthomyxoviridae InfectionMyxovirus Infection
- Registration Number
- NCT00703651
- Lead Sponsor
- Sanofi Pasteur, a Sanofi Company
- Brief Summary
This is a follow-up of a previous dose-ranging study aimed at investigating 2 doses of the trivalent inactivated split virion influenza vaccine when administered by intradermal route with that of the current pharmaceutical presentation administered by intramuscular route.
Primary Objective:
To assess the immunogenicity of two pharmaceutical presentations of the trivalent inactivated split virion influenza vaccine 21 days after a single injection in subjects aged 18 to 57 years.
Secondary Objective:
To evaluate the safety profile during the 21-day period following each vaccination in each study group
- Detailed Description
This is an open (for the administration route) and double-blind (only for the two dosages administered at year 0 by using the investigational administration route) randomized trial conducted in subjects aged 18 to 60 years. The subjects will receive three vaccine injections at 1-year interval.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1150
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method To provide information concerning the immunogenicity of Inactivated, Split-Virion Influenza Vaccine. 21days post-vaccination To provide information concerning the safety of Inactivated, Split-Virion Influenza Vaccine 21 days post-vaccination and entire study duration
- Secondary Outcome Measures
Name Time Method