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Sponsors and Collaborators: |
Sinovac Biotech Co., Ltd Centers for Disease Control and Prevention, China |
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Information provided by: | Sinovac Biotech Co., Ltd |
ClinicalTrials.gov Identifier: | NCT00660257 |
A single center, non-randomized clinical trial in two-dose primed healthy adults to evaluate the safety and immunogenicity of a booster dose of an inactivated pandemic influenza (H5N1) vaccine (whole-virion, aluminium-adjuvanted).
Condition | Intervention | Phase |
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Pandemic Influenza Vaccine Prevention Pandemic Influenza |
Biological: pandemic influenza vaccine (H5N1 strain NIBRG-14) |
Phase I |
Study Type: | Interventional |
Study Design: | Prevention, Non-Randomized, Double Blind (Subject, Outcomes Assessor), Parallel Assignment |
Official Title: | Safety and Immunogenicity of Booster Dose of An Inactivated,Adjuvanted Whole-Virion Pandemic Influenza (H5N1)Vaccine in Two-Dose Primed Healthy Adults: A Single Center, Non-Randomized Clinical Trial |
Enrollment: | 57 |
Study Start Date: | January 2007 |
Study Completion Date: | March 2008 |
Primary Completion Date: | March 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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No.1: 1.25 ug: Experimental |
Biological: pandemic influenza vaccine (H5N1 strain NIBRG-14)
pandemic influenza vaccine (H5N1 strain NIBRG-14) booster (third) dose: 1.25 ug per dose, intramuscular injection
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No.2: 2.5 ug: Experimental |
Biological: pandemic influenza vaccine (H5N1 strain NIBRG-14)
pandemic influenza vaccine (H5N1 strain NIBRG-14) booster (third) dose: 2.5 ug per dose, intramuscular injection
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No.3: 5.0 ug: Experimental |
Biological: pandemic influenza vaccine (H5N1 strain NIBRG-14)
pandemic influenza vaccine (H5N1 strain NIBRG-14) booster (third) dose: 5.0 ug per dose, intramuscular injection
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No. 4: 10 ug: Experimental |
Biological: pandemic influenza vaccine (H5N1 strain NIBRG-14)
pandemic influenza vaccine (H5N1 strain NIBRG-14) booster (third) dose: 1.25 ug per dose, intramuscular injection
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Ages Eligible for Study: | 19 Years to 61 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Study ID Numbers: | PRO-PanFlu-1002 |
Study First Received: | April 15, 2008 |
Last Updated: | April 16, 2008 |
ClinicalTrials.gov Identifier: | NCT00660257 History of Changes |
Health Authority: | China: State Food and Drug Administration |
Virus Diseases Respiratory Tract Diseases Respiratory Tract Infections Influenza, Human |
Influenza in Birds Healthy Orthomyxoviridae Infections |
Virus Diseases RNA Virus Infections Respiratory Tract Diseases |
Respiratory Tract Infections Influenza, Human Orthomyxoviridae Infections |