NCT00914771

Safety and Immunogenicity of Two Doses, Administered Three Weeks Apart, of Two Monovalent H5N1 Influenza Vaccines Containing 2 Doses of H5N1 Influenza Antigen, in Non-elderly Adult and Elderly Subjects

A Phase II, Randomized, Controlled, Double-blind, Multi-center, Study to Evaluate Safety and Immunogenicity of Two Doses, Administered Three Weeks Apart, of Two Monovalent H5N1 (Surface Antigen Adjuvanted With MF59C.1) Influenza Vaccines Containing 3.75 µg or 7.5 μg of H5N1 Influenza Antigen, in Non-elderly Adult and Elderly Subjects

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 722 (actual)
• Sponsor: Novartis Vaccines · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This study aims to demonstrate the non-inferiority of two doses of H5N1 influenza antigen in non-elderly and elderly adult subjects in order to submit an extension application for a lower dose of Focetria.

Conditions

• Pandemic H5N1 Influenza

Interventions

Type	Name	Description
BIOLOGICAL	H5N1 pandemic Influenza vaccine 3.75µg	2 doses of monovalent MF59-adjuvanted H5N1 pandemic vaccine containing 3.75µg H5N1 antigen
BIOLOGICAL	H5N1 pandemic Influenza vaccine 7.5µg	2 doses of monovalent MF59-adjuvanted H5N1 pandemic vaccine containing 7.5µg H5N1 antigen

Timeline

• Start date: 2009-09-01
• Primary completion: 2009-12-01
• Completion: 2009-12-01
• First posted: 2009-06-05
• Last updated: 2015-10-12

Locations

12 sites across 2 countries: Poland, Turkey (Türkiye)