NCT01382329

H5N1 Vaccine Study in Japanese Adults

A Blinded, Randomized Phase 2/3 Study to Assess Immunogenicity and Safety of Two Different Dose Levels of a Vero Cell-Derived Whole Virus H5N1 Influenza Vaccine in a Healthy Japanese Adult Population Aged 18 to 59 Years

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 340 (actual)
• Sponsor: Alachua Government Services, Inc. · Industry
• Sex: All
• Age: 18 Years – 59 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to obtain immunogenicity and safety data of two different dose levels of an H5N1 pandemic influenza vaccine in a healthy Japanese adult population aged 18 to 59 years.

Conditions

• H5N1 Influenza

Interventions

Type	Name	Description
BIOLOGICAL	H5N1 (pre-)pandemic influenza vaccine (whole virion, Vero Cell derived, inactivated)	Intramuscular injection into the musculus deltoideus or subcutaneous injection in the upper arm

Timeline

• Start date: 2011-06-01
• Primary completion: 2011-08-01
• Completion: 2012-05-01
• First posted: 2011-06-27
• Last updated: 2015-10-09

Locations

3 sites across 1 country: Japan