NCT00703651

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

Immunogenicity of Two Dosages of Inactivated, Split-Virion Influenza Vaccine Administered by Intradermal Route in Comparison With Intramuscular Vaccination With Vaxigrip® in Adults

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 1,150 (actual)
• Sponsor: Sanofi Pasteur, a Sanofi Company · Industry
• Sex: All
• Age: 18 Years – 57 Years
• Healthy volunteers: Accepted

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

Detailed description

This is an open (for the administration route) and double-blind (only for the two dosages administered at year 0 by using the investigational administration route) randomized trial conducted in subjects aged 18 to 60 years. The subjects will receive three vaccine injections at 1-year interval.

Conditions

• Influenza
• Orthomyxoviridae Infection
• Myxovirus Infection

Interventions

Type	Name	Description
BIOLOGICAL	Inactivated, split-virion influenza vaccine	0.1 mL, ID. 1 injection/year for 3 years
BIOLOGICAL	Inactivated, split-virion influenza vaccine	0.1 mL, ID. 1 injection/year for 3 years.
BIOLOGICAL	Inactivated, split-virion influenza vaccine	0.5 mL, IM. 1 injection/year for 3 years

Timeline

• Start date: 2003-09-01
• Primary completion: 2006-05-01
• Completion: 2006-07-01
• First posted: 2008-06-23
• Last updated: 2014-01-13

Locations

8 sites across 3 countries: Belgium, Czechia, Lithuania