NCT00481065

Immunogenicity, Safety and Tolerability of Prepandemic Influenza and Seasonal Influenza Vaccine in Adult Subjects

A Phase II, Randomized, Controlled, Open Label, Single-Center Study to Evaluate the Immunogenicity, Safety and Tolerability of an H5N1-vaccine and a Seasonal Influenza Vaccine in Adult Subjects

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 405 (actual)
• Sponsor: Novartis · Industry
• Sex: All
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

Summary

This study evaluates the immunogenicity, safety and tolerability of an H5N1 vaccine with a seasonal trivalent influenza vaccine, containing the strains recommended by WHO for the 2007 influenza season in the Southern Hemisphere.

Conditions

• Pandemic
• Avian Influenza

Interventions

Type	Name	Description
BIOLOGICAL	MF59-eH5N1
BIOLOGICAL	eTIV_a
BIOLOGICAL	MF59-eH5N1 + eTIV_a

Timeline

• Start date: 2007-04-01
• Primary completion: 2008-12-01
• Completion: 2008-12-01
• First posted: 2007-06-01
• Last updated: 2014-02-03
• Results posted: 2013-02-28

Locations

1 site across 1 country: Colombia