Study of Immune Response in Adults and Elderly Subjects Vaccinated With Inactivated Influenza Vaccines
Phase 2
Completed
- Conditions
- InfluenzaOrthomyxovirus InfectionsMyxovirus Infection
- Interventions
- Biological: Inactivated, split-virion, influenza vaccineBiological: Inactivated, split-virion influenza vaccine
- Registration Number
- NCT00776438
- Lead Sponsor
- Sanofi Pasteur, a Sanofi Company
- Brief Summary
To further characterize the immune responses induced after an influenza vaccination performed either via the ID or the IM routes in two clearly distinct populations.
Objectives:
* To describe the immune response per age group and vaccine group after vaccination.
* To describe the safety of the vaccines per age group and per vaccine group after vaccination.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 160
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Study Group 1 Inactivated, split-virion, influenza vaccine Adult, age 18 to 40 years Study Group 2 Inactivated, split-virion, influenza vaccine Adult, age 18 to 40 years Study Group 3 Inactivated, split-virion influenza vaccine Elderly, age 60 to 85 years Study Group 4 Inactivated, split-virion influenza vaccine Elderly, age 60 to 85 years
- Primary Outcome Measures
Name Time Method To provide information concerning immune response to an inactivated, split-virion, influenza vaccine. 21 days 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