Randomized, Double Blinded, Placebo Control Clinical Trial of Pandemic Influenza Inactive Vaccine on Healthy Subjects
Based on pre-clinical trial data and principle of GCP, the objective of phase I clinical trial is to evaluate safety and immunogenicity of Pan-flu vaccine, an inactivated whole virion H5N1 vaccine with aluminium hydroxide adjuvant.
Biological: an inactivated whole virion H5N1 vaccine, adjuvanted
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Primary Purpose: Prevention
|Official Title:||The Phase-I Clinical Trial Protocol for the Pandemic Inactivated Influenza Vaccine|
- To evaluate the safety of pandemic inactivated influenza vaccine by different does.
- To evaluate the immunogenicity of pandemic inactivated influenza vaccine by different does.
|Study Start Date:||December 2005|
|Estimated Study Completion Date:||April 2006|
|China-Japan Friendship Hospital|
|Beijing, Beijing, China, 100029|
|Principal Investigator:||Jiangtao Lin, MD||China-Japan Friendship Hospital|