NCT00959465

A/H1N1 Immunogenicity and Safety in Adults

An Open Label Phase 1/2 Study to Assess Immunogenicity and Safety of Different Dose Levels of H1N1 Pandemic Influenza Vaccine in Healthy Adults Aged 18 Years and Older

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 408 (actual)
• Sponsor: Alachua Government Services, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The purpose of the study is to obtain immunogenicity and safety data at different dose levels of an investigational H1N1 pandemic influenza vaccine in healthy adults 18 years of age and older.

Conditions

• Influenza
• Pandemic Influenza

Interventions

Type	Name	Description
BIOLOGICAL	H1N1 pandemic influenza vaccine (whole virion, Vero Cell-derived, inactivated)	Two injections at a 21-day interval (Days 1 and 22)

Timeline

• Start date: 2009-08-01
• Primary completion: 2009-11-01
• Completion: 2010-04-01
• First posted: 2009-08-14
• Last updated: 2015-10-09

Locations

5 sites across 2 countries: Austria, Germany