EUCTR2012-005137-37-DE进行中（未招募）不适用
Open-label, non-controlled, multicenter immunogenicity and safety study of MVA-BN® smallpox vaccine in children from birth to less than 12 years of age
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.Children from birth to < 12 years of age (depending on group allocation) in good health as determined by medical history, physical examination and clinical judgment.
- •2.No prior smallpox or Modified Vaccinia Ankara (MVA) based vaccination or known exposure to smallpox prior to trial entry.
- •3.The subject’s parents/guardian have read, signed and dated the informed consent form, having been advised of the risks and benefits of the trial in a language understood by the subject's parents and prior to performance of any trial specific procedures
- •4.No history of chronic or known neurological disease or deficient development history.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 342
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.Any clinically significant condition which in the opinion of the investigator would compromise the safety of the subject, i.e. the risk would outweigh the benefit of receiving the vaccine (i.e. any uncontrolled serious infection, i.e. not responding to antimicrobial therapy; known or suspected impairment of immunologic function; acute disease with or without pyrexia; temperature more than or equal to 38.0°C [more than or equal to100.4°F]; post organ transplant subjects whether or not receiving chronic immunosuppressive therapy; any other history or clinical manifestation of clinically significant haematological, pulmonary, central nervous, cardiovascular or gastrointestinal disorders).
- •2.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 trial conclusion.
- •3.History of or currently active autoimmune disease. Children with vitiligo or thyroid disease on thyroid replacement therapy are not excluded.
- •4.History of malignancy, especially leukaemia or lymphoma.
- •5.History of allergic disease or hypersensitivity likely to be exacerbated by any component of the vaccine.
- •6.History of anaphylaxis or severe allergic reaction.
- •7.Chronic administration (defined as more than 14 days) of systemic high dose immune-suppressant drugs during a period starting from six months prior to administration of vaccine and ending at trial 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.
- •8.Use of any investigational or non-registered drug or vaccine other than the trial vaccine within 30 days preceding the first dose of the study vaccine, or planned administration of such a drug during the trial period.
研究者
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