NCT00491257

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

Immunogenicity and Safety of the Inactivated, Split-Virion Influenza Vaccine, Northern Hemisphere 2007-2008 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 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.

Conditions

• Influenza
• Orthomyxoviridae Infections

Interventions

Type	Name	Description
BIOLOGICAL	Inactivated influenza vaccine (split virion) NH 2007-2008 formulation	0.5 mL, Intramuscular

Timeline

• Start date: 2007-06-01
• Primary completion: 2007-07-01
• Completion: 2007-07-01
• First posted: 2007-06-26
• Last updated: 2014-01-17

Locations

2 sites across 1 country: United Kingdom