NCT00491985

Safety and Immunogenicity of 2 Formulations of an Intramuscular A/H5N1 Pandemic Influenza Vaccine in Children

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 240 (actual)
• Sponsor: Sanofi Pasteur, a Sanofi Company · Industry
• Sex: All
• Age: 6 Months – 18 Years
• Healthy volunteers: Accepted

Summary

This is an open, randomized, multicenter clinical trial. Objectives: * To describe the safety profiles during the 21 days following each primary and booster injection. * To describe the immune response 21 days after each primary and booster injection of each formulation. * To describe the antibody persistence after the first vaccination

Conditions

• Influenza
• Orthomyxoviridae Infections
• Influenza A Virus Infection

Interventions

Type	Name	Description
BIOLOGICAL	A/H5N1 Inactivated, split-virion pandemic influenza vaccine	0.5 mL, Intramuscular
BIOLOGICAL	A/H5N1 Inactivated, split virion pandemic influenza vaccine	0.5 mL, Intramuscular
BIOLOGICAL	A/H5N1 Inactivated, split virion pandemic influenza vaccine	0.25 mL, Intramuscular

Timeline

• Start date: 2007-06-01
• Primary completion: 2009-12-01
• Completion: 2010-06-01
• First posted: 2007-06-27
• Last updated: 2014-01-14

Locations

1 site across 1 country: Thailand