Study of Inactivated, Split-Virion Influenza Vaccine Administered by Intradermal Route Versus Vaxigrip® in Adults

Summary

This is a follow-up of a previous dose-ranging study aimed at investigating 2 doses of the trivalent inactivated split virion influenza vaccine when administered by intradermal route with that of the current pharmaceutical presentation administered by intramuscular route. Primary Objective: To assess the immunogenicity of two pharmaceutical presentations of the trivalent inactivated split virion influenza vaccine 21 days after a single injection in subjects aged 18 to 57 years. Secondary Objective: To evaluate the safety profile during the 21-day period following each vaccination in each study group

Timeline

Start

2003-09

Primary completion

2006-05

Completion

2006-07

Publications

• Beran J, Ambrozaitis A, Laiskonis A, Mickuviene N, Bacart P, Calozet Y, Demanet E, Heijmans S, Van Belle P, Weber F, Salamand C. Intradermal influenza vaccination of healthy adults using a new microinjection system: a 3-year randomised controlled safety and immunogenicity trial. BMC Med. 2009 Apr 2;7:13. doi: 10.1186/1741-7015-7-13.

Drugs

Indications