NCT00884182

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 350 (actual)
• Sponsor: Sanofi Pasteur, a Sanofi Company · Industry
• Sex: All
• Age: 6 Months – 17 Years
• Healthy volunteers: Accepted

Summary

This study is part of an effort to develop an effective vaccination program in children in the event of a pandemic. Study objectives: * To describe the safety profiles in the periods following each vaccination in subjects receiving different vaccination schedule. * To describe the immune response after each vaccination in subjects receiving study vaccine.

Detailed description

Study participants will receive two administrations of the investigational vaccine at one of 3 vaccination schedules.

Conditions

• Influenza
• Orthomyxoviridae Infections
• Orthomyxovirus Infections

Interventions

Type	Name	Description
BIOLOGICAL	A/H5N1 Inactivated, Split Virion Pandemic Influenza Vaccine	0.5 mL, Intramuscular

Timeline

• Start date: 2009-04-01
• Primary completion: 2010-03-01
• Completion: 2010-06-01
• First posted: 2009-04-20
• Last updated: 2014-01-14

Locations

13 sites across 1 country: Finland