NCT01195038

Immunogenicity and Safety Study of a Booster Vaccination With a Recombinant H5N1 Influenza HA Vaccine in Primed Adults

A Multicenter, Open-Label Study to Assess the Immunogenicity and Safety of a Booster Vaccination With a Recombinant H5N1 Influenza HA Vaccine in Healthy Young Adults Primed With a Two-Vaccination of a Recombinant H5N1 Influenza HA Vaccine

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 87 (estimated)
• Sponsor: UMN Pharma Inc. · Industry
• Sex: All
• Age: 21 Years – 41 Years
• Healthy volunteers: Accepted

Summary

The study is designed to assess the immunogenicity and safety of one booster vaccination with 45 μg of a recombinant H5N1 influenza (A/Indonesia/05/2005) HA vaccine in healthy young adults, previously primed with a two-vaccination of 3 different doses of a recombinant H5N1 influenza (A/Vietnam/1203/2004) HA vaccine in a priming study (JPIP501-01a, NCT00980447).

Conditions

• Influenza

Interventions

Type	Name	Description
BIOLOGICAL	Recombinant Influenza HA Vaccine (H5N1)	one booster dose of 45 μg rHA derived from A/Indonesia/05/2005 strain

Timeline

• Start date: 2010-10-01
• Primary completion: 2011-01-01
• Completion: 2011-01-01
• First posted: 2010-09-03
• Last updated: 2011-02-08

Locations

2 sites across 1 country: Japan