Safety and Immunogenicity of an Intramuscular Pandemic Influenza Vaccine in Adults and the Elderly

Phase 2

Completed

• Conditions: Influenza; Orthomyxoviridae Infections
• Interventions: Biological: A/H5N1 inactivated, split-virion influenza virus

• Registration Number: NCT00415129
• Lead Sponsor: Sanofi Pasteur, a Sanofi Company

Brief Summary

Based on the results from a previous formulation/dosage ranging trial, this phase II multicenter, open trial was designed to determine the safety and immunogenicity of two vaccine formulation/dosages with and without adjuvant 21 days after each vaccination in adults (18 to 60 years and in the elderly (\> 60 years) as required by the European Medicines Agency (EMEA) guideline. The antibody persistence until the booster vaccination at 6 or 12 months will also be evaluated.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-06
• Study First Submitted: 2006-12-21
• Study First Submitted QC: 2006-12-21
• Study First Posted: 2006-12-22
• Primary Completion: 2008-12
• Study Completion: 2009-03
• Status Verified: 2014-01
• Last Update Submitted: 2014-01-10
• Last Update Posted: 2014-01-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Study Group 1	A/H5N1 inactivated, split-virion influenza virus	Vaccine with adjuvant
Study Group 2	A/H5N1 inactivated, split-virion influenza virus	Vaccine without adjuvant

Primary Outcome Measures

Name	Time	Method
To provide information concerning the safety of an A/H5N1 inactivated, split-virion influenza virus vaccine	21 Days post-vaccination