NCT01052402

Safety and Immunogenicity Study of a H5N1 Influenza Vaccine (Vero Cell-Derived, Whole Virus) in Healthy Infants, Children and Adolescents

A Phase 1/2 Study to Assess the Safety and Immunogenicity of a Vero Cell-Derived Whole Virus H5N1 Influenza Vaccine in Healthy Infants, Children and Adolescents Aged 6 Months to 17 Years

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 684 (actual)
• Sponsor: Alachua Government Services, Inc. · Industry
• Sex: All
• Age: 6 Months – 17 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to assess the safety and immunogenicity (i.e. primary immune response, immunogenicity of two different doses, antibody persistence 360 days after the first vaccination, immune response to a heterologous booster given on Day 360) of a Vero cell-derived whole virus H5N1 influenza vaccine in healthy infants, children and adolescents aged 6 months to 17 years.

Conditions

• Influenza, Avian

Interventions

Type	Name	Description
BIOLOGICAL	H5N1 Influenza Vaccine (Whole Virion, Vero Cell-Derived, Inactivated), non-adjuvanted formulation	Two vaccinations, 21 days apart, followed by a heterologous booster vaccination on Day 360

Timeline

• Start date: 2009-12-01
• Primary completion: 2011-11-01
• Completion: 2012-11-01
• First posted: 2010-01-20
• Last updated: 2015-10-09

Locations

20 sites across 4 countries: Australia, Finland, Singapore, Spain