ISRCTN89141709已完成不适用
Open label, randomised, parallel-group, multi-centre study to evaluate the safety, tolerability and immunogenicity of Baxter H1N1 vaccine and GlaxoSmithKline H1N1 vaccine in children 6 months to 12 years of age
niversity of Oxford (UK)0 个研究点目标入组 1,000 人开始时间: 2009年9月24日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,000
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Baby or child (both males and females) aged between 6 months to 12 years of age (i.e., to day before 13th birthday)
- •2. For whom a parent/legal guardian has given written informed consent after the nature of the study has been explained
- •3. Available for all the visits scheduled in the study
- •4. Willingness to complete all study procedures
排除标准
- •1. History of any vaccine against novel influenza A strain H1N1 (based on verbal confirmation from parent/guardian)
- •2. Previous laboratory confirmed case of novel influenza A strain H1N1 or treatment with oseltamivir or zanamivir for novel influenza A strain H1N1 (n.b. a child commenced on treatment with oseltamivir or zanamivir for novel influenza A strain H1N1 whose treatment was stopped following negative microbiological tests for H1N1 on nasal swabs would be allowed to enrol in the study)
- •3. History of severe allergic reaction after previous vaccinations or hypersensitivity to any H1N1 vaccine component
- •4. Current egg allergy
- •5. Known or suspected impairment/alteration of the immune system
- •6. Disorders of coagulation
- •7. Immunosuppressive therapy, use of systemic corticosteroids for more than 1 week within the 3 months prior to enrolment
- •8. Receipt of blood, blood products and/or plasma derivatives or any immunoglobulin preparation within 3 months prior to enrolment
- •9. Intent to immunise with any other vaccine(s) against novel influenza A strain H1N1 throughout the study period
- •10. Participation in another clinical trial of an investigational medical product
- •11. Any condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives. Children with chronic, stable medical illnesses that do not result in immunosuppression (e.g., cerebral palsy, epilepsy, cystic fibrosis, congenital heart disease) will be allowed to participate in the study, unless these conditions will in some way interfere with the completion of study procedures. Children with conditions that may alter the immune response to vaccines (e.g., Trisomy 21) or will affect the ability to accurately describe adverse events (e.g., children over 5 years of age but with severe learning difficulties) will be excluded
研究者
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Open Label, Randomized, Parallel-Group, Multi-Center Study to Evaluate the Safety, Tolerability and Immunogenicity of Baxter H1N1 vaccine and GlaxoSmithKline H1N1 vaccine in children 6 months to 12 years of age. - Head-to-head comparison of two H1N1 swine influenza vaccines in childreEUCTR2009-014719-11-GBniversity of Oxford