A Clinical Trial With Influenza A/H1N1 Vaccines
Summary
A single center, stratified, randomized and double-blind phase IV clinical trial is to be conducted in healthy elders (equal to or more than 61 years), adults (18-60 years), adolescents (12-17 years) and children (3-11 years) to evaluate the safety and immunogenicity of Sinovac's split-virion or whole-virion novel influenza A (H1N1) vaccines.
Study Design
Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Conditions
Influenza
Intervention
split-virion, adjuvanted H1N1 vaccine of 7.5 μg per dose, split-virion, adjuvanted H1N1 vaccine of 15 μg per dose, split-virion, non-adjuvanted H1N1 vaccine of 15 μg per dose, split-virion, non-adjuvanted H1N1 vaccine of 30 μg per dose, whole-virion,
Location
Beijing Centers for Diseases Control and Prevention
Beijing
China
Status
Completed
Source
Sinovac Biotech Co., Ltd
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00956111
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Split-brain Procedure
Complete severing of the CORPUS CALLOSUM. In humans it is usually performed to treat medically intractable, multifocal EPILEPSY. EXPERIMENTAL ANIMAL MODELS of split brain preparations are used in research.
Kininogens
Endogenous peptides present in most body fluids. Certain enzymes convert them to active KININS which are involved in inflammation, blood clotting, complement reactions, etc. Kininogens belong to the cystatin superfamily. They are cysteine proteinase inhibitors. HIGH-MOLECULAR-WEIGHT KININOGEN; (HMWK); is split by plasma kallikrein to produce BRADYKININ. LOW-MOLECULAR-WEIGHT KININOGEN; (LMWK); is split by tissue kallikrein to produce KALLIDIN.
Viral Structures
The structural parts of the VIRION.
Exons
The parts of a transcript of a split GENE remaining after the INTRONS are removed. They are spliced together to become a MESSENGER RNA or structural RNA.
Fat Necrosis
A condition in which the death of adipose tissue results in neutral fats being split into fatty acids and glycerol.
Clinical Trials
A Clinical Trial of Split-virion Influenza A/H1N1 Vaccines
A single center, Open-Label phase IV clinical trial is to be conducted in healthy elders (equal to or more than 61 years to evaluate the immunogenicity and safety of Sinovac's 15μg H1N1 i...
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A Study of the Immunogenicity of Swine-origin A/H1N1 Influenza Vaccine in Healthy Adults
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The purpose of this study is to generate data on immunogenicity and safety of the monovalent H1N1 vaccine in support of the development and registration. Primary objectives: - T...
PubMed Articles
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