PACTR201401000363170已完成未知
Safety and immunogenicity of a heterologous prime-boost vaccine strategy with AdCh63 ME-TRAP and MVA ME-TRAP in infants in a malaria endemic area
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 36
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
- 年龄范围
- 10 Month(s) 至 12 Month(s)（—）
- 性别
- All
入选标准
- •For Stage 1: Healthy male and female infants aged 5-12 months at the time of enrolment with consenting parents.
- •For Stage 2: Healthy male and female infants aged 10 weeks at the time of enrolment with consenting parents.
排除标准
- •Any of the following constitutes an exclusion criterion:
- •¿Clinically significant history of skin disorder (psoriasis, contact dermatitis etc.), allergy, symptomatic immunodeficiency, cardiovascular disease, respiratory disease, endocrine disorder, liver disease, renal disease, gastrointestinal disease, neurological illness.
- •¿Severe malnutrition.
- •¿History of allergic disease or reactions likely to be exacerbated by any component of the vaccines, e.g. egg products, Kathon, neomycin, betapropiolactone.
- •¿History of splenectomy
- •¿Haemoglobin less than 8.0 g/dL, where judged to be clinically significant in the opinion of the investigator
- •¿Serum Creatinine concentration greater than 70 ¿mol/L, where judged to be clinically significant in the opinion of the investigator
- •¿Serum ALT concentration greater than 45 U/L, where judged to be clinically significant in the opinion of the investigator
- •¿Blood transfusion within one month of enrolment.
- •¿History of vaccination with previous experimental malaria vaccines.
- •¿Administration of any other vaccine or immunoglobulin less than two weeks before vaccination with the IMPs
- •¿Current participation in another clinical trial, or within 12 weeks of this study.
- •¿Any other finding which in the opinion of the investigators would increase the risk of an adverse outcome from participation in the trial.
- •¿Likelihood of travel away from the study area
- •¿Maternal HIV infection
- •¿Positive malaria antigen test at screening
- •¿Failure to have received, prior to enrolment, the routine EPI vaccinations due according to the Gambian EPI schedule.
研究者
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