NCT00895544

Immunogenicity and Safety Study of a Single Prime-Boost Vaccination Schedule With a H5N1 Influenza Vaccine in Adults

An Open-Label Phase 1/2 Study to Assess the Immunogenicity and Safety of a Single Prime-Boost Vaccination Schedule With a Vero Cell-Derived Whole Virus H5N1 Influenza Vaccine in Healthy Volunteers Aged 18 to 59 Years

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 231 (actual)
• Sponsor: Alachua Government Services, Inc. · Industry
• Sex: All
• Age: 18 Years – 59 Years
• Healthy volunteers: Accepted

Summary

The main objective of the study is to assess the immune response to a non-adjuvanted H5N1 influenza vaccine in an adult population when administered according to a single prime-boost schedule.

Conditions

• Influenza
• Avian Influenza

Interventions

Type	Name	Description
BIOLOGICAL	Influenza vaccine (whole virion, Vero cell derived)	Dose A (Vietnam strain) for priming vaccination (Day 0) - Dose B (Indonesia strain) for booster vaccination (Day 360)
BIOLOGICAL	Influenza vaccine (whole virion, Vero cell derived)	Dose A (Vietnam strain) for priming vaccination (Day 0) - Dose A (Indonesia strain) for booster vaccination (Day 360)

Timeline

• Start date: 2009-05-01
• Primary completion: 2010-10-01
• Completion: 2011-06-01
• First posted: 2009-05-08
• Last updated: 2015-10-09

Locations

3 sites across 2 countries: Austria, Finland