Study of Influenza Vaccine (Split Virion, Inactivated) Northern Hemisphere 2009-2010 Formulation
Phase 2
Completed
- Conditions
- Influenza
- Interventions
- Biological: Influenza virus (split virion, inactivated) vaccine
- Registration Number
- NCT00946179
- Lead Sponsor
- Sanofi Pasteur, a Sanofi Company
- Brief Summary
This study is in support of the annual application for the variation of the vaccine strains for a marketing authorization.
Objectives:
* To evaluate the compliance, in terms of immunogenicity, of the influenza vaccine (split virion, inactivated) Northern Hemisphere (NH) 2009-2010 formulation in two adult groups, aged 18 to 60 years and aged 61 years or older.
* To describe the safety of the influenza vaccine (split virion, inactivated) NH 2009-2010 formulation in both adult groups.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 130
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group 1 Influenza virus (split virion, inactivated) vaccine Participants aged 18 to 60 years at enrollment Group 2 Influenza virus (split virion, inactivated) vaccine Participants aged 61 years or older at enrollment
- Primary Outcome Measures
Name Time Method To provide information concerning the immunogenicity of intramuscular (IM) Influenza Vaccine (Split Virion, Inactivated), Northern Hemisphere 2009-2010 Formulation. 21 days post-vaccination To provide information concerning the safety of intramuscular (IM) Influenza Vaccine (Split Virion, Inactivated), Northern Hemisphere 2009-2010 Formulation 0 to 7 days post-vaccination and entire study duration
- Secondary Outcome Measures
Name Time Method