Safety and Immunogenicity of Fluzone® Vaccine in Children Who Received 2 Doses of the 2005-2006 Fluzone Formulation.

Phase 4

Completed

• Conditions: Influenza

• Registration Number: NCT00390884
• Lead Sponsor: Sanofi Pasteur, a Sanofi Company

Brief Summary

To compare the groups with respect to influenza immune responses following Dose 1 of Fluzone vaccine (2006-2007 formulation).

Detailed Description

Not available

Study Timeline

• Study Start: 2006-10
• Study First Submitted: 2006-10-20
• Study First Submitted QC: 2006-10-20
• Study First Posted: 2006-10-23
• Primary Completion: 2007-06
• Study Completion: 2008-09
• Results First Submitted: 2009-09-21
• Results First Submitted QC: 2009-11-30
• Results First Posted: 2009-12-31
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-12
• Last Update Posted: 2016-04-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 173

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Percentage of Seroprotected Participants Post-vaccination With Fluzone®	Day 28 Post-vaccination	Seroprotection was defined as a Post-vaccination Hemagglutination Inhibition titer of greater than or equal to 1:40.

Secondary Outcome Measures

Name	Time	Method
Geometric Mean Titers (GMTs) of Hemagglutination Inhibition Antibodies Post-vaccination With Fluzone®	Day 28 Post-vaccination	Antibodies against Influenza virus in Fluzone® Vaccine determined by the Hemagglutination inhibition (HAI) assay method.