NCT00545701

Immunogenicity and Safety of an Intramuscular A/H5N1 Inactivated, Split Virion Pandemic Influenza Vaccine in Adults

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Sanofi Pasteur, a Sanofi Company · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

The trial is a Phase II, open-label trial in healthy subjects aged 18 to 60 years to support the immunogenicity data from previous clinical studies. Objectives: * To describe the immune response 21 days after each vaccination. * To describe the safety profiles following each vaccination.

Conditions

• Influenza
• Orthomyxoviridae Infections

Interventions

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

Timeline

• Start date: 2007-10-01
• Primary completion: 2008-06-01
• Completion: 2008-09-01
• First posted: 2007-10-17
• Last updated: 2014-01-14

Locations

2 sites across 1 country: Australia