EUCTR2012-005815-25-DE进行中（未招募）不适用
A Phase 3b, Single-Center, Open-label Study to Assess the Immunogenicity and Safety of Novartis Meningococcal B Recombinant Vaccine When Administered at a 0, 2-Month Schedule in Healthy at-Risk Adults Aged 18 to 65 Years inclusive.
ovartis Vaccines and Diagnostics S.r.l.0 个研究点开始时间: 2013年5月17日最近更新:
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
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
- •18 – 65 years of age inclusive who have given written informed consent at the time of enrollment;
- •Who are available for all the visits scheduled in the study (i.e., not planning to leave the area before the end of the study period);
- •In good health as determined by medical history, physical examination and clinical judgment of the investigator;
- •Who are or might be routinely exposed to cultures of N. meningitidis serogroup B.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 50
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Pregnancy or nursing (breastfeeding) mothers;
- •Females of reproductive age who have not used or do not plan to use acceptable birth control measures, for the 3 months duration of the study. Oral, injected or implanted hormonal contraceptive, diaphragm, condom, intrauterine device or sexual abstinence are considered acceptable forms of birth control. If sexually active the subject must have been using one of the accepted birth control methods for at least 60 days prior to study entry;
- •Any serious chronic or progressive disease according to judgment of the investigator;
- •Individuals with history of any progressive or severe neurologic disorder, or seizure disorder. A single episode of febrile convulsion is not an exclusion criteria;
- •History of any serogroup B meningococcal vaccine administration;
- •Previous known or suspected disease caused by N. meningitidis;
- •History of severe allergic reaction after previous vaccinations, or hypersensitivity to any component of the vaccine;
- •Known or suspected autoimmune disease or impairment/alteration of the immune system;
- •Subjects who are not able to comprehend and to follow all required study procedures for the whole period of the study;
- •History or any illness/condition that, in the opinion of the investigator, might interfere with the results of the study or pose additional risk to the subjects due to participation in the study;
- •Any significant chronic infection;
- •Known bleeding diathesis or any condition that may be associated with a prolonged bleeding time;
- •Family members and household members of research staff;
- •Participation in another clinical trial within the last 30 days or planned for during
研究者
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