NCT00891007已完成2 期
Partially Randomized, Controlled Phase II Study to Evaluate Safety, Dose Response and Immunogenicity of the Measles Vaccine MVA mBN85B in Healthy Children Aged 6 Months to 6 Years
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 2
研究概览
简要总结
Partially randomized, controlled Phase II study to evaluate safety, immunogenicity and dose response of the measles vaccine MVA mBN85B in healthy children aged 6 months to 6 years.
详细描述
Open label study to assess the safety and immunogenicity of MVA-mBN85B in healthy vaccine-naive, measles-naive and measles-experienced children. The study is comprised of three groups with 30 children each. Two groups will receive two subcutaneous (s.c.) immunizations 4 weeks (28±3 days) apart of either either 1 x 10E7 TCID50 (Group A) or 1 x 10E8 TCID50 (Group B) MVA mBN85B. The control group (Group C) will receive two s.c. doses (0.5 ml, 1000 TCID50) of Rouvax® (Sanofi-Pasteur) 24 weeks apart.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 6 Months 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Read, signed and dated informed consent document from one parent/guardian of the child after being advised of the risks and benefits of the study in a language understood by the parent/guardian. This document must be signed prior to performance of any study specific procedure.
- •Male or female child between the age of 6 months to 6 years (Group C: 9 months to 6 years).
- •Prior or no prior measles vaccination indicated on the RTHC.
- •No known exposure to measles within 30 days prior to study entry.
- •No history of measles disease.
- •Negative human immunodeficiency virus antibody test (anti-HIV) and hepatitis B surface antigen (HBsAG).
- •Child is in good health as determined by medical history, physical examination and clinical judgment.
- •Children for whom the investigator reasonably believes its parents/guardian can and will comply with the requirements of the protocol
排除标准
- •Any clinically significant condition that may influence participation in this study, including febrile convulsions.
- •Severe malnutrition as assessed by the investigator by weight for age and clinical criteria.
- •History of splenectomy.
- •Clinically significant anaemia (laboratory and clinical criteria).
- •Having received any vaccinations or planned vaccinations with a live vaccine within 30 days prior to or after study vaccination.
- •Having received any vaccinations or planned vaccinations with a killed vaccine within 14 days prior to or after study vaccination.
- •Administration or planned administration of immunoglobulins and/or any blood products during a period starting from 3 months prior to administration of the vaccine and ending at study conclusion.
- •Use of any investigational or non-registered drug or vaccine other than the study vaccine within 30 days preceding the first dose of the study vaccine, or planned administration of such a drug during the study period.
- •History of any serious medical condition, which in the opinion of the investigator, would compromise the safety of the child.
- •History of or currently active autoimmune disease. Children with vitiligo or thyroid disease on thyroid replacement therapy are not excluded.
- •History of malignancy, especially leukaemia or lymphoma.
- •History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
- •History of anaphylaxis or severe allergic reaction.
- •Known allergy to egg proteins, gelatine, neomycin or gentamycin.
- •Chronic administration (defined as more than 14 days) of systemic high dose immuno-suppressant drugs during a period starting from six months prior to administration of the vaccine and ending at study conclusion. High dose is defined as 2 mg/kg/day or more of prednisolone or its equivalent, or 20 mg/day or more for children who weigh more than 10 kg.
- •Previous participation in an MVA-based vaccination study
研究者
研究点 (2)
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