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

NCT01052402 Phase 1/Phase 2 COMPLETED

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.

Details

Lead sponsor	Alachua Government Services, Inc.
Phase	Phase 1/Phase 2
Status	COMPLETED
Enrolment	684
Start date	2009-12
Completion	2012-11

Conditions

• Influenza, Avian

Interventions

• H5N1 Influenza Vaccine (Whole Virion, Vero Cell-Derived, Inactivated), non-adjuvanted formulation

Primary outcomes

• Frequency and severity of systemic reactions until 7 days after the first vaccination — 7 days
• Rate of subjects with antibody response to the vaccine strain associated with protection 21 days after the second vaccination defined as titer measured by Microneutralization test >= 1:20. — 42 days

Countries

Australia, Finland, Singapore, Spain