Safety and Immunogenicity of an Intramuscular A/H5N1 Inactivated, Split Virion Pandemic Influenza Vaccine in Children

Phase 2

Completed

• Conditions: Influenza; Orthomyxoviridae Infections; Orthomyxovirus Infections

• Registration Number: NCT00884182
• Lead Sponsor: Sanofi Pasteur, a Sanofi Company

Brief Summary

This study is part of an effort to develop an effective vaccination program in children in the event of a pandemic.

Study objectives:

* To describe the safety profiles in the periods following each vaccination in subjects receiving different vaccination schedule.

* To describe the immune response after each vaccination in subjects receiving study vaccine.

Detailed Description

Study participants will receive two administrations of the investigational vaccine at one of 3 vaccination schedules.

Study Timeline

• Study Start: 2009-04
• Study First Submitted: 2009-04-16
• Study First Submitted QC: 2009-04-17
• Study First Posted: 2009-04-20
• Primary Completion: 2010-03
• Study Completion: 2010-06
• Status Verified: 2014-01
• Last Update Submitted: 2014-01-10
• Last Update Posted: 2014-01-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 350

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 the safety of the Split Virion Pandemic Influenza vaccine.	21 days post-vaccination and entire study

Secondary Outcome Measures

Name	Time	Method
To provide information concerning the immunogenicity of Split Virion Pandemic Influenza vaccine.	21 days post-vaccination