CTRI/2009/091/000585招募中3 期
Persistence of antibodies after vaccination with GSK Biologicals meningococcal vaccine GSK 134612 in adolescents and young adults.
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 697
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
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 109069.
- •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 109069.
- •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 subjects first visit.
- •Bleeding disorders, such as thrombocytopenia, or subjects on anti-coagulant therapy
- •Subjects who withdrew consent to be contacted for follow-up studies.
研究者
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