NCT00415129

Safety and Immunogenicity of an Intramuscular Pandemic Influenza Vaccine in Adults and the Elderly

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 600 (actual)
• Sponsor: Sanofi Pasteur, a Sanofi Company · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

Based on the results from a previous formulation/dosage ranging trial, this phase II multicenter, open trial was designed to determine the safety and immunogenicity of two vaccine formulation/dosages with and without adjuvant 21 days after each vaccination in adults (18 to 60 years and in the elderly (\> 60 years) as required by the European Medicines Agency (EMEA) guideline. The antibody persistence until the booster vaccination at 6 or 12 months will also be evaluated.

Conditions

• Influenza
• Orthomyxoviridae Infections

Interventions

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

Timeline

• Start date: 2006-06-01
• Primary completion: 2008-12-01
• Completion: 2009-03-01
• First posted: 2006-12-22
• Last updated: 2014-01-14

Locations

4 sites across 2 countries: Belgium, United Kingdom