NCT00258934

Immunogenicity Study of the Influenza Vaccine in Adults

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 978 (actual)
• Sponsor: Sanofi Pasteur, a Sanofi Company · Industry
• Sex: All
• Age: 18 Years – 57 Years
• Healthy volunteers: Accepted

Summary

All marketed influenza vaccines are injected by the intramuscular (IM) route. This study will test whether an influenza vaccine is effective when injected by a route other than into the muscle. In order to prove this, the amount of antibodies in the blood will be measured before and after vaccination. In addition, the safety of both influenza vaccines will be tested by evaluating all serious reactions occurring after vaccination. The vaccine injected in this study is similar to the sponsor's marketed intramuscular influenza vaccine (Vaxigrip). In addition, the safety of both influenza vaccines administered by different routes will be tested by evaluating all adverse events and especially all serious reactions. Primary Objective: To demonstrate and compare the immune response of an influenza vaccine after a single dose when administered by different routes. Secondary Objectives: To describe the compliance of the immunogenicity of the vaccine with the European Medicine Agency (EMEA) after the first injection.

Conditions

• Orthomyxoviridae Infections
• Influenza

Interventions

Type	Name	Description
BIOLOGICAL	Inactivated, split-virion influenza vaccine	0.1 mL single annual dose
BIOLOGICAL	Inactivated, split-virion, influenza virus	0.5 mL single annual dose

Timeline

• Start date: 2005-09-01
• Primary completion: 2008-06-01
• Completion: 2008-09-01
• First posted: 2005-11-28
• Last updated: 2014-01-14

Locations

4 sites across 3 countries: Belgium, Germany, Switzerland