Immunogenicity and Safety of a Vaccine Against Influenza (2010-2011 Northern Hemisphere Season, Intradermal Route)
- Conditions
- Influenza
- Interventions
- Biological: Influenza virus vaccine (split virion, inactivated)
- Registration Number
- NCT01138397
- Lead Sponsor
- Sanofi Pasteur, a Sanofi Company
- Brief Summary
The aim of this study is to evaluate the new formulation of the influenza vaccine for the 2010-2011 Northern Hemisphere (NH) season in terms of immunogenicity and safety in the corresponding population and to check its compliance with the Committee for Proprietary Medicinal Products (CPMP) Note for Guidance (NfG) CPMP/BWP/214/96
Objectives:
* To evaluate compliance, in terms of immunogenicity, of the corresponding strength of the intradermal (ID) influenza vaccine NH 2010-2011 formulation with the requirements of the CPMP NfG CPMP/BWP/214/96.
* To describe the safety of the corresponding strength of the ID influenza vaccine, NH 2010-2011 formulation.
- Detailed Description
Each participant will receive a dose of their assigned vaccine on Day 0 and will be followed up for 21 days post-vaccination.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 129
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group 1 Influenza virus vaccine (split virion, inactivated) Participants at 18 to 59 years of age Group 2 Influenza virus vaccine (split virion, inactivated) Participants at 60 years of age or older
- Primary Outcome Measures
Name Time Method Information concerning the safety (solicited and unsolicited adverse events) of the Influenza virus vaccine (Split Virion, Inactivated), Northern Hemisphere 2010-2011 Formulation. 21 days post-vaccination Information concerning the immunogenicity of the Influenza virus vaccine (Split Virion, Inactivated), Northern Hemisphere 2010-2011 Formulation. 21 days post-vaccination
- Secondary Outcome Measures
Name Time Method