Immunogenicity and Safety of the Inactivated, Split-Virion Influenza Vaccine, Northern Hemisphere 2008-2009 Formulation

Phase 2

Completed

• Conditions: Influenza; Orthomyxoviridae Infections
• Interventions: Biological: Split virion, inactivated Influenza vaccine

• Registration Number: NCT00718146
• Lead Sponsor: Sanofi Pasteur, a Sanofi Company

Brief Summary

This study is for a new marketing authorization application for the seasonal vaccine strains in compliance with the Note for Guidance (NfG) on harmonization requirements for influenza vaccine from the Committee for Human Medicinal Products (CHMP)

Objectives:

* To evaluate the compliance, in terms of immunogenicity, of the inactivated, split-virion influenza vaccine NH 2008-2009 formulation with the requirements of the CHMP NfG CPMP/BWP/214/96.

* To describe the safety of the inactivated, split-virion influenza vaccine, NH 2008-2009 formulation.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-05-07
• Study Start: 2008-06
• Study First Submitted QC: 2008-07-16
• Study First Posted: 2008-07-18
• Primary Completion: 2008-08
• Study Completion: 2008-09
• Status Verified: 2014-01
• Last Update Submitted: 2014-01-16
• Last Update Posted: 2014-01-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 130

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1	Split virion, inactivated Influenza vaccine	Age 16 to 60 years
Group 2	Split virion, inactivated Influenza vaccine	Age over 60 years

Primary Outcome Measures

Name	Time	Method
Immunogenicity: To provide information concerning the immunogenicity of Influenza vaccine (split virion, inactivated).	21 days post vaccination