A Study of the Immunogenicity and Safety of the 2007-2008 Influenza Vaccine

Phase 2

Completed

• Conditions: Influenza; Orthomyxoviridae Infections
• Interventions: Biological: Inactivated influenza vaccine (split virion) NH 2007-2008 formulation

• Registration Number: NCT00491257
• Lead Sponsor: Sanofi Pasteur, a Sanofi Company

Brief Summary

This study is designed to generate clinical data as outlined in the Note for Guidance on harmonization requirements for influenza vaccine marketing authorization by the European Medicines Agency.

The objectives of the trial are:

* To determine immunogenicity, of the inactivated, split-virion influenza vaccine Northern Hemisphere (NH) 2007-2008 formulation in terms of the requirements of the Committee for Human Medicinal Products (CHMP) Note for Guidance (NfG) CPMP/BWP/214/96.

* To describe the safety of the inactivated, split-virion influenza vaccine, NH 2007-2008 formulation.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-06
• Study First Submitted: 2007-06-25
• Study First Submitted QC: 2007-06-25
• Study First Posted: 2007-06-26
• Primary Completion: 2007-07
• Study Completion: 2007-07
• 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: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Study Group 2	Inactivated influenza vaccine (split virion) NH 2007-2008 formulation	Participants aged 61 years or older at enrollment.
Study Group 1	Inactivated influenza vaccine (split virion) NH 2007-2008 formulation	Participants aged 18 to 60 years at enrollment

Primary Outcome Measures

Name	Time	Method
To provide information concerning the immunogenicity of 2007-2008 Influenza vaccine (split virion, inactivated).	21 Days post-vaccination