drugset / Trial / NCT00545701

Immunogenicity and Safety of an Intramuscular A/H5N1 Inactivated, Split Virion Pandemic Influenza Vaccine in Adults

NCT00545701 ↗

Phase 2 Completed 100 enrolled Sanofi Pasteur, a Sanofi Company
Non-randomizedSingle-groupOpen-labelPrevention

Summary

The trial is a Phase II, open-label trial in healthy subjects aged 18 to 60 years to support the immunogenicity data from previous clinical studies. Objectives: * To describe the immune response 21 days after each vaccination. * To describe the safety profiles following each vaccination.

Timeline

Start
2007-10
Primary completion
2008-06
Completion
2008-09

Drugs

EvaluationDrugModalityDoseRoute
Subject A/H5N1 inactivated, split-virion influenza virus Vaccine 0.5 ml Intramuscular

Indications