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drugset / Trial / NCT00718146

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

NCT00718146 ↗

Phase 2 Completed 130 enrolled Sanofi Pasteur, a Sanofi Company
Non-randomizedParallel-groupOpen-labelPrevention

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.

Timeline

Start
2008-06
Primary completion
2008-08
Completion
2008-09

Drugs

EvaluationDrugModalityDoseRoute
Subject Split virion, inactivated Influenza vaccine Vaccine 0.5 ml Intramuscular

Indications

influenza