EUCTR2012-000283-23-Outside-EU/EEA进行中（未招募）不适用
A phase III, open, randomized, controlled primary vaccination study to demonstrate the non-inferiority of meningococcal vaccine GSK134612 given intramuscularly versus Mencevax™ ACWY given subcutaneously to healthy subjects aged 2 through 10 years of age - MenACWY-TT-038
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
- 1,504
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 or guardians can and will comply with the requirements of the protocol.
- •- A male or female between, and including, 2 and 10 years of age at the time of vaccination.
- •- Written informed consent obtained from the parent or guardian of the subject.
- •- Free of obvious health problems as established by medical history and clinical examination before entering into the study.
- •- Previously completed routine childhood vaccinations to the best of his/her parents'/guardians' knowledge.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 1504
- •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
- •- Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
- •- Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
- •- Planned administration/ administration of a vaccine not foreseen by the study protocol within one month of the dose of vaccine.
- •- Previous vaccination with meningococcal polysaccharide vaccine of serogroup A, C, W-135 and/or Y (for subjects below 6 years) or within the last five previous years (for subjects 6 years old or above).
- •- Previous vaccination with meningococcal polysaccharide conjugate vaccine of serogroups A, C, W-135 and/or Y.
- •- Previous vaccination with tetanus toxoid within the last month.
- •- History of meningococcal disease.
- •- Any confirmed or suspected immunosuppressive or immunodeficient condition (congenital or secondary), including human immunodeficiency virus (HIV) infection, based on medical history and physical examination..
- •- History of reactions or allergic disease likely to be exacerbated by any component of the vaccine(s).
- •- Major congenital defects or serious chronic illness.
- •- Acute disease at the time of enrolment.
- •- Administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine or planned administration during the study period.
研究者
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