NCT00945438

Study of the Influenza Vaccine (Split Virion, Inactivated) Northern Hemisphere 2009-2010 Formulation (Intradermal Route)

Immunogenicity and Safety of the Influenza Vaccine (Split Virion, Inactivated), Northern Hemisphere 2009-2010 Formulation (Intradermal Route)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 131 (actual)
• Sponsor: Sanofi Pasteur, a Sanofi Company · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This study is in support of the annual application for the variation of the vaccine strains for a marketing authorisation. Objectives: * To evaluate compliance, in terms of immunogenicity, of the corresponding strength of the intradermal (ID) influenza vaccine Northern Hemisphere (NH) 2009-2010 formulation. * To describe the safety of the corresponding strength of the ID influenza vaccine, NH 2009-2010 formulation.

Conditions

• Influenza

Interventions

Type	Name	Description
BIOLOGICAL	Influenza virus vaccine 2009-2010 formulation	0.1 mL, Intradermal
BIOLOGICAL	Influenza virus vaccine 2009-2010 formulation	0.5 mL, Intradermal

Timeline

• Start date: 2009-05-01
• Primary completion: 2009-06-01
• Completion: 2009-07-01
• First posted: 2009-07-24
• Last updated: 2014-01-14

Locations

2 sites across 1 country: France