drugset / Trial / NCT00664417

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

NCT00664417 ↗

Phase 1 Completed 375 enrolled Sanofi
RandomizedParallel-groupSingle-blindPrevention

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.

Timeline

Start
2008-04
Primary completion
2009-09
Completion
2010-08

Drugs

EvaluationDrugModalityDoseRoute
Comparator Monovalent subvirion H5N1 influenza vaccine Vaccine 0.5 ml Intramuscular

Indications