EUCTR2006-000518-19-ES进行中（未招募）不适用
A Phase III, open, multicentre study to assess the long-term persistence of a booster dose of GSK Biologicals? Hib-MenC conjugate vaccine compared to a booster dose of Infanrix? hexa (combined diphtheria-tetanus-acellular pertussis-hepatitis B-inactivated polio-Hib vaccine) when given to 14-month-old subjects who were primed in study 217744/097 (DTPa-HBV-IPV-097) and boosted in study Hib-MenC-TT-010 BST: DTPa-HBV-IPV-097. - Hib-MenC-TT-022 EXT 010 M18; 023; 024; 025; 026
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
- 184
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
- •?Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol
- •?A male or female in their third year of life at the time of the study initiation for the subjects who enter the study at Visit 1. The subjects who enter the study at Visit 2 should be in their fourth year of life at the time of study initiation
- •?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 booster vaccination study Hib-MenC-TT-010 BST:DTPA-HBV-IPV-097.
- •?Subjects who are part of the Meningitec? control group and who were not enrolled at Visit 1 can be enrolled at Visit 2 if they have completed the booster vaccination study Hib-MenC-TT-010 BST:DTPA-HBV-IPV-097 and if they have received a fourth dose of Meningitec? in their second year of life, after the booster study Hib-MenC-TT-010 BST:DTPA-HBV-IPV-097.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 184
- •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
- •?Previous administration of a booster dose of Hib or meningococcal serogroup C except booster study vaccines during the study Hib-MenC-TT-010 BST:DTPA-HBV-IPV-097. Subjects who received a 4th dose of Meningitec? should be included in the study.
- •?History of H. influenzae type b, meningococcal serogroup C diseases
研究者
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