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drugset / Trial / NCT00491257

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

NCT00491257 ↗

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

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.

Timeline

Start
2007-06
Primary completion
2007-07
Completion
2007-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Influenza Virus Vaccine Vaccine 0.5 ml Intramuscular

Indications

influenza