Safety and Immunogenicity of H5N1 Adjuvanted, Inactivated, Split-Virion Pandemic Influenza Vaccine in Healthy Adults

Phase 1

Completed

• Conditions: Pandemic Influenza; Influenza A Virus Infection; Orthomyxoviridae Infections
• Interventions: Biological: A/H5N1 inactivated, split-virion influenza vaccine+Adjuvant; Biological: A/H5N1 inactivated, split-virion influenza vaccine

• Registration Number: NCT00457509
• Lead Sponsor: Sanofi Pasteur, a Sanofi Company

Brief Summary

The purpose of this study is to test different adjuvanted vaccine formulations as a two-dose schedule in immunologically naïve adults against one vaccine formulation without adjuvant in terms of tolerance and immunogenicity

Primary Objective:

To describe the safety profile and immunogenicity following each injection.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-01
• Study First Submitted: 2007-04-05
• Study First Submitted QC: 2007-04-05
• Study First Posted: 2007-04-06
• Primary Completion: 2009-11
• Study Completion: 2010-09
• Status Verified: 2014-01
• Last Update Submitted: 2014-01-10
• Last Update Posted: 2014-01-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 251

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1	A/H5N1 inactivated, split-virion influenza vaccine+Adjuvant	Dose 1 with Adjuvant
Group 2	A/H5N1 inactivated, split-virion influenza vaccine+Adjuvant	Dose 2 with adjuvant
Group 3	A/H5N1 inactivated, split-virion influenza vaccine+Adjuvant	Dose 3 with adjuvant
Group 4	A/H5N1 inactivated, split-virion influenza vaccine+Adjuvant	Dose 4 with adjuvant
Group 5	A/H5N1 inactivated, split-virion influenza vaccine	Control

Primary Outcome Measures

Name	Time	Method
To provide information concerning the safety of A/H5N1 Inactivated split influenza virus vaccine	Entire study period