EUCTR2012-004060-22-Outside-EU/EEA进行中（未招募）不适用
A phase II, open, controlled, multicenter study to evaluate the long-term antibody persistence at 1, 3 and 5 years after the administration of a four dose vaccination series of Hib-MenCY-TT vaccine compared to ActHIB in subjects given a four dose vaccination series in study Hib-MenCY-TT-005/006. - Hib-MenCY-TT-013 EXT:006 Y1/Hib-MenCY-TT-014 EXT:006 Y3/Hib-MenCY-TT-015 EXT:006 Y5
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 443
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
- •Healthy male and female children who completed the previous four dose vaccination series study (NCT00129129). The age of the child at the 3 post-fourth dose timelines are as follows:
- •Year 1: 22 to 36 months of age.
- •Year 3: 44 to 60 months of age.
- •Year 5: 5 years post-dose 4 +/- 8 weeks
- •Written informed consent obtained from the parent or guardian of the subject.
- •Healthy subjects as established by medical history and clinical examination before entering into the study
- •Having completed the fourth dose vaccination of study Hib-MenCY-TT-005/006
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 487
- •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
- •Children should not have:
- •received more than 4 doses of Hib or meningococcal serogroup C and Y vaccine
- •had a history of H. influenzae type b, meningococcal serogroup C and Y diseases.
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