ISRCTN16993271已完成未知
The effect of live attenuated inactivated influenza vaccine on experimental human pneumococcal carriage: a randomised controlled trial
Royal Liverpool and Broadgreen University Hospitals NHS Trust0 个研究点目标入组 314 人开始时间: 2015年9月4日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 314
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
- •Participants will be eligible to participate in this study provided they:
- •1. Have capacity to give informed consent
- •2. Aged 18-50 yrs - ages chosen to minimise the risk of pneumococcal infection
- •3. Speak fluent English to ensure a comprehensive understanding of the research project and their proposed involvement, in order to minimise any communication issues to maximise participant safety
排除标准
- •1. Currently involved in another study unless observational or in follow-up phase (noninterventional)
- •2. Received any influenza vaccine in the last 2 years
- •3. Egg allergy (as per influenza vaccines patient leaflet)
- •4. Previous significant adverse reaction to any vaccination/immunisation
- •5. Close contact with at risk individuals (children under 5 years, immunosuppressed adults, elderly, chronic ill health) – to minimise risk of pneumococcal transmission and transmission of virus for those receiving the LAIV
- •6. Current regular smoker (smokes daily)
- •7. Significant smoking history [defined as someone who has previously smoked more than 20 cigarettes per day for 10 years or the equivalent (>10 pack yrs)] – to minimise risk of bronchoscopy or pneumococcal disease
- •8. Asthma (on regular medication) or respiratory disease – to minimise risk of bronchoscopy or pneumococcal disease
- •9. Pregnant to minimise the risk of pneumococcal disease
- •10. Women of childbearing potential (WOCBP) who are not deemed to have sufficient, effective birth control in place for 1 month prior to vaccination and 1 month after the final vaccination
- •11. Allergic to penicillin/amoxicillin/ gentamicin
- •12. On medication that may affect the immune system in any way e.g. steroids, steroid nasal spray
- •13. Are regularly taking acetylsalicylic acid (aspirin) – as per LAIV guidance to reduce the risk of Reye’s syndrome
- •14. Been involved in a clinical trial involving EHPC over the last 3 years
- •15. Unable to give fully informed consent
- •16. Current acute severe febrile illness - to avoid vaccination and inoculation in participants that may have current infection
研究者
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