NCT00664417

Study of Different Formulations of an Intramuscular A/H5N1 Inactivated, Split Virion Influenza Adjuvanted Vaccine

Safety and Immunogenicity of Different Formulations of an Intramuscular A/H5N1 Inactivated, Split Virion Influenza Adjuvanted Vaccine in Healthy Adults

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 375 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

Summary

Following the licensure of sanofi pasteur's 90 µg rgA/Vietnam/1203/2004 pandemic influenza vaccine, efforts to develop a lower antigen dose formulation with improved immunogenicity using adjuvants were initiated. The present study is part of this endeavor. It is primarily a formulation/dose-finding study with a secondary aim at generating safety and immunogenicity data for the final formulation for the development of a pre-pandemic vaccine.

Detailed description

This is a Phase I, observer-blinded, randomized, controlled multicenter, dose-finding study in adult subjects. All vaccines will be administered as a two-dose schedule in (H5N1) immunologically-naïve adults. Immunogenicity and safety will be evaluated after each injection.

Conditions

• Influenza
• Orthomyxoviridae Infections

Interventions

Type	Name	Description
BIOLOGICAL	Monovalent subvirion H5N1 influenza vaccine	0.5 mL, IM, 2 injections, Formulation 1
BIOLOGICAL	Monovalent subvirion H5N1 influenza vaccine	0.5 mL, IM, 2 injections, Formulation 2
BIOLOGICAL	Monovalent subvirion H5N1 influenza vaccine	0.5 mL, IM, 2 injections, Formulation 3
BIOLOGICAL	Monovalent subvirion H5N1 influenza vaccine	0.5 mL, IM, 2 injections, Formulation 4
BIOLOGICAL	Monovalent subvirion H5N1 influenza vaccine	0.5 mL, IM, 2 injections, Formulation 5
BIOLOGICAL	Monovalent subvirion H5N1 influenza vaccine	0.5 mL, IM, 2 injections, Formulation 6
BIOLOGICAL	Monovalent subvirion H5N1 influenza vaccine	0.5 mL, IM, 2 injections, Comparator 1
BIOLOGICAL	Monovalent subvirion H5N1 influenza vaccine	0.5 mL, IM, 2 injections, Comparator 2
BIOLOGICAL	Physiological saline	0.5 mL, IM, 2 injections

Timeline

• Start date: 2008-04-01
• Primary completion: 2009-09-01
• Completion: 2010-08-01
• First posted: 2008-04-23
• Last updated: 2012-04-17

Locations

6 sites across 1 country: United States