Persistence of Antibodies After Vaccination With GSK Biologicals' Meningococcal Vaccine GSK134612 in Adolescents and Young Adults
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 697
- 试验地点
- 6
- 主要终点
- Number of Seroprotected Subjects Against the Vaccine Meningococcal Serogroups
研究概览
简要总结
Subjects were previously vaccinated at 11 to 17 years of age. This extension phase starts 24 months after vaccination and the subjects who were vaccinated in the primary study will be enrolled in this extension phase. No new subjects will be enrolled.
详细描述
Subjects were previously vaccinated at 11 to 17 months of age with GSK Biologicals' meningococcal vaccine 134612 or with Mencevax™. This extension phase starts 24 months after vaccination and the subjects who were vaccinated in the primary study will be enrolled in this extension phase. No new studies will be enrolled. The subjects will have 4 blood samples taken: at 24, 36, 48 and 60 months after vaccination.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 11 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects who the investigator believes that they and/or their parent(s)/guardian(s) can and will comply with the requirements of the protocol should be enrolled in the study.
- •A male or female having been vaccinated with a meningococcal vaccine in the primary study
- •Written informed consent obtained from parent(s)/guardian(s) of the subject and written informed assent obtained from the subject if the subject is less than 18 years of age, or written informed consent obtained from the subject if the subject has achieved the 18th birthday.
- •Healthy subjects as established by medical history and clinical examination before entering into the study.
排除标准
- •Use of any investigational or non-registered product (drug or vaccine) within 30 days preceding the subject's first visit.
- •History of meningococcal disease; such cases will be documented.
- •Administration of a meningococcal polysaccharide or a meningococcal polysaccharide conjugate vaccine since previous vaccination in study
- •Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history.
- •Administration of immunoglobulins and/or any blood products within the three months preceding the subject's first visit.
- •Bleeding disorders, such as thrombocytopenia, or subjects on anti-coagulant therapy
- •Subjects who withdrew consent to be contacted for follow-up studies.
结局指标
主要结局
Number of Seroprotected Subjects Against the Vaccine Meningococcal Serogroups
时间窗: At Month 60 post primary dose
A seroprotected subject was defined as a subject who had anti-meningococcal serogroups A (MenA), C (MenC), W-135 (MenW-135) and Y (MenY) antibody titers equal to or above (≥) the cut-off value of 1:8. The persistence of serum bactericidal antibodies was evaluated using baby rabbit complement (rSBA) titers. The blood analyses for this timepoint were performed solely at the Public Health of England's (PHE) laboratory.
次要结局
- Antibody Concentrations Against the Vaccine Polysaccharides(At Month 24 post primary dose)
- Number of Seropositive Subjects Against the Vaccine Meningococcal Serogroups(At Months 24, 36, 48 and 60 post primary dose)
- Number of Subjects With Antibody Concentrations Against the Vaccine Polysaccharides(At Month 24 post primary dose)
- Antibody Titers Against the Vaccine Meningococcal Serogroups(At Months 24, 36, 48 and 60 post primary dose)