Safety and Immunogenicity of 2 Formulations of an Intramuscular A/H5N1 Pandemic Influenza Vaccine in Children

Phase 2

Completed

• Conditions: Influenza; Orthomyxoviridae Infections; Influenza A Virus Infection
• Interventions: Biological: A/H5N1 Inactivated, split-virion pandemic influenza vaccine; Biological: A/H5N1 Inactivated, split virion pandemic influenza vaccine

• Registration Number: NCT00491985
• Lead Sponsor: Sanofi Pasteur, a Sanofi Company

Brief Summary

This is an open, randomized, multicenter clinical trial.

Objectives:

* To describe the safety profiles during the 21 days following each primary and booster injection.

* To describe the immune response 21 days after each primary and booster injection of each formulation.

* To describe the antibody persistence after the first vaccination

Detailed Description

Not available

Study Timeline

• Study Start: 2007-06
• Study First Submitted: 2007-06-26
• Study First Submitted QC: 2007-06-26
• Study First Posted: 2007-06-27
• Primary Completion: 2009-12
• 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: 240

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Study Group 1	A/H5N1 Inactivated, split-virion pandemic influenza vaccine	Subjects aged 9 to 17 years
Study Group 2	A/H5N1 Inactivated, split virion pandemic influenza vaccine	Subjects aged 3 to 8 years
Study Group 3	A/H5N1 Inactivated, split virion pandemic influenza vaccine	Subjects aged 6 to 35 months

Primary Outcome Measures

Name	Time	Method
To describe safety following administration of A/H5N1 inactivated split virion pandemic influenza vaccine.	21 Days post-vaccination