NCT00457509

Safety and Immunogenicity of H5N1 Adjuvanted, Inactivated, Split-Virion Pandemic Influenza Vaccine in Healthy Adults

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 251 (actual)
• Sponsor: Sanofi Pasteur, a Sanofi Company · Industry
• Sex: All
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to test different adjuvanted vaccine formulations as a two-dose schedule in immunologically naïve adults against one vaccine formulation without adjuvant in terms of tolerance and immunogenicity Primary Objective: To describe the safety profile and immunogenicity following each injection.

Conditions

• Pandemic Influenza
• Influenza A Virus Infection
• Orthomyxoviridae Infections

Interventions

Type	Name	Description
BIOLOGICAL	A/H5N1 inactivated, split-virion influenza vaccine+Adjuvant	0.5 mL, Intramuscular
BIOLOGICAL	A/H5N1 inactivated, split-virion influenza vaccine+Adjuvant	0.5 mL, Intramuscular
BIOLOGICAL	A/H5N1 inactivated, split-virion influenza vaccine+Adjuvant	0.5 mL, Intramuscular
BIOLOGICAL	A/H5N1 inactivated, split-virion influenza vaccine+Adjuvant	0.5 mL, Intramuscular
BIOLOGICAL	A/H5N1 inactivated, split-virion influenza vaccine	0.5 mL, Intramuscular

Timeline

• Start date: 2007-01-01
• Primary completion: 2009-11-01
• Completion: 2010-09-01
• First posted: 2007-04-06
• Last updated: 2014-01-14

Locations

3 sites across 1 country: Belgium