ISRCTN45340436已完成未知
Pneumococcal Conjugate Vaccine (PCV-13) and Experimental Human Pneumococcal Carriage Study (EHPC) Study
Royal Liverpool and Broadgreen University Hospitals NHS Trust (UK)0 个研究点目标入组 100 人开始时间: 2013年11月18日最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 100
研究概览
简要总结
2014 results in: T4 Pneumococcal Conjugate Vaccine Reduces Rate, Density And Duration Of Experimental Human Pneumococcal Colonisation: First Human Challenge Testing Of A Pneumococcal Vaccine. Thorax 2014;69:A2 doi:10.1136/thoraxjnl-2014-206260.4 2021 results in https://pubmed.ncbi.nlm.nih.gov/34159375/ (added 24/06/2021)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Adults, male and female aged 18-50 years old (chosen to minimise the risk of pneumococcal infection post inoculation).
- •2. Fluent English spoken (to ensure a comprehensive understanding of the research project and their involvement this is predominately for safety reasons).
排除标准
- •1. Previously received PPV or any PCV vaccines (at any age) ? full vaccine history obtained from General Practitioner as necessary
- •2. Previously lived in a hepatitis A endemic area
- •3. Previously received a complete course of hepatitis A vaccination
- •4. Previous significant adverse reaction to any vaccination/immunisation
- •5. Close contact with at risk individuals (children, immunosuppressed adults, elderly, chronic ill health) ? to minimise risk of pneumococcal transmission
- •6. Current smoker or significant smoking history (>10 pack yrs) ? to minimise risk of pneumococcal infection and optional bronchoscopy
- •7. Asthma (on regular medication) or respiratory disease ? to minimise risk of bronchoscopy or pneumococcal infection
- •8. Pregnancy ? to minimise risk of pneumococcal infection and no safety data exists for either vaccine in pregnancy
- •9. Breast-feeding mothers no ? safety data exists for either vaccine in pregnancy
- •10. Women of child-bearing potential (WOCBP) who are deemed not 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
- •12. Involved in another clinical trial unless observational or in follow-up (non-interventional) phase
- •13. Previously been involved in a clinical trial involving experimental human pneumococcal carriage
- •14. Unable to give fully informed consent
- •15. Medication that may affect the immune system (e.g. steroids, steroid nasal spray)
- •16. Current acute severe febrile illness at the time of vaccination/inoculation.
研究者
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