NCT00718146

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 130 (actual)
• Sponsor: Sanofi Pasteur, a Sanofi Company · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Influenza
• Orthomyxoviridae Infections

Interventions

Type	Name	Description
BIOLOGICAL	Split virion, inactivated Influenza vaccine	0.5 mL, Intramuscular (IM)
BIOLOGICAL	Split virion, inactivated Influenza vaccine	0.5 mL, Intramuscular (IM)

Timeline

• Start date: 2008-06-01
• Primary completion: 2008-08-01
• Completion: 2008-09-01
• First posted: 2008-07-18
• Last updated: 2014-01-17

Locations

2 sites across 1 country: United Kingdom