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| Sponsor: | Sinovac Biotech Co., Ltd |
|---|---|
| Collaborator: |
Ministry of Science and Technology of the People´s Republic of China |
| Information provided by: | Sinovac Biotech Co., Ltd |
| ClinicalTrials.gov Identifier: | NCT00356798 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Influenza |
Biological: an inactivated whole virion H5N1 vaccine, adjuvanted |
Phase I |
| Study Type: | Interventional |
| Study Design: | Prevention, Randomized, Double-Blind, Placebo Control, Factorial Assignment, Safety/Efficacy Study |
| Official Title: | The Phase-I Clinical Trial Protocol for the Pandemic Inactivated Influenza Vaccine |
| Estimated Enrollment: | 120 |
| Study Start Date: | December 2005 |
| Estimated Study Completion Date: | April 2006 |
Eligibility| Ages Eligible for Study: | 18 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Abnormal result of laboratory test as below:
Subject has received any of the following substances:
Contacts and Locations| China | |
| China-Japan Friendship Hospital | |
| Beijing, China, 100029 | |
| Principal Investigator: | Jiangtao Lin, MD | China-Japan Friendship Hospital |
More Information
| Study ID Numbers: | PRO-PanFlu-1001 |
| Study First Received: | July 25, 2006 |
| Last Updated: | November 8, 2007 |
| ClinicalTrials.gov Identifier: | NCT00356798 History of Changes |
| Health Authority: | China: State Food and Drug Administration |
|
pandemic influenza H5N1 vaccine |
|
Virus Diseases RNA Virus Infections Respiratory Tract Diseases |
Respiratory Tract Infections Influenza, Human Orthomyxoviridae Infections |