EUCTR2012-005816-25-FI进行中（未招募）1 期
A phase III, open, multi-centre, controlled study to evaluate the long-term antibody persistence at 2, 3, 4, 5 and 6 years after a booster dose of meningococcal serogroup A, C, W-135, Y- tetanus toxoid conjugate vaccine (MenACWY-TT) or Meningitec® administered in healthy 5-year-old children in study MENACWY-TT-048 EXT: 039 Y2, 3, 4, 5 (112036), who were primed with thesame vaccine in study MENACWY-TT-039 (109670) at 12 through 23 months of age. - C0921001 (MENACWY-TT-102 EXT: 048 Y2, 3, 4, 5, 6)
Pfizer Inc (235 East 42nd Street, New York, New York 10017)0 个研究点目标入组 248 人开始时间: 2013年5月17日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 248
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
- •All subjects must satisfy ALL the following criteria at study entry:
- •Subjects’ parent(s)/Legally Acceptable Representative(s) [LAR(s)] who, in the opinion of the investigator, can and will comply with the requirements of the protocol (e.g. return for follow-up visits).
- •A male or female who has received primary and booster vaccination with the MenACWY-TT or Meningitec vaccines in studies MENACWY-TT-039 (109670) and MENACWY-TT-048 EXT: 039 Y2, 3, 4, 5 (112036), respectively.
- •Written informed consent obtained from the parent(s)/LAR(s) of the subject.
- •Healthy subjects as established by medical history and clinical examination before entering into the study.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 248
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range 0
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •The following criteria should be checked at the time of study entry. If ANY exclusion criterion applies, the subject must not be included in the study:
- •Child in care
- •History of meningococcal disease.
- •Administration of a meningococcal polysaccharide or a meningococcal polysaccharide conjugate vaccine outside of studies MENACWY-TT-039 (109670) and MENACWY-TT-048 EXT: 039 Y2, 3, 4, 5 (112036).
- •Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
- •Bleeding disorders, such as thrombocytopenia, or subjects on anti-coagulant therapy.
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