Study of Immune Response in Adults and Elderly Subjects Vaccinated With Inactivated Influenza Vaccines

Phase 2

Completed

• Conditions: Influenza; Orthomyxovirus Infections; Myxovirus Infection

• 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

Study Timeline

• Study Start: 2007-09
• Study First Submitted: 2008-10-17
• Study First Submitted QC: 2008-10-17
• Study First Posted: 2008-10-21
• Primary Completion: 2009-02
• Study Completion: 2009-04
• Status Verified: 2015-06
• Last Update Submitted: 2015-06-16
• Last Update Posted: 2015-06-17

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

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