NCT01121822

Immunogenicity and Safety of a Vaccine Against Influenza (2010-2011 Northern Hemisphere Season, Intramuscular Route)

Immunogenicity and Safety of the Influenza Vaccine (Split Virion, Inactivated), Northern Hemisphere 2010-2011 Formulation (Intramuscular Route)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 129 (actual)
• Sponsor: Sanofi Pasteur, a Sanofi Company · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The aim of this study is to evaluate the new formulation of the influenza vaccine for the 2010-2011 Northern Hemisphere (NH) season in terms of immunogenicity and safety in the corresponding population and to check its compliance with the Committee for Proprietary Medicinal Products (CPMP) Note for Guidance (NfG) CPMP/BWP/214/96 Objectives: * To evaluate the compliance, in terms of immunogenicity, of the influenza vaccine (split virion, inactivated) NH 2010-2011 formulation with the requirements of the Committee for Proprietary Medicinal Products (CPMP) Note for Guidance (NfG) CPMP/BWP/214/96 in both age groups * To describe the safety of the influenza vaccine (split virion, inactivated) NH 2010-2011 formulation in both age groups

Detailed description

Each participant will receive a dose of vaccine on Day 0 and will be followed up for 21 days post-vaccination.

Conditions

• Influenza

Interventions

Type	Name	Description
BIOLOGICAL	Influenza virus vaccine (split virion, inactivated)	0.5 mL, Intramuscular
BIOLOGICAL	Influenza virus vaccine (split virion, inactivated)	0.5 mL, Intramuscular

Timeline

• Start date: 2010-05-01
• Primary completion: 2010-06-01
• Completion: 2010-06-01
• First posted: 2010-05-12
• Last updated: 2015-10-06

Locations

3 sites across 1 country: France