EUCTR2012-000282-20-Outside-EU/EEA进行中（未招募）不适用
A phase III, randomized, open, controlled, multicenter primary vaccination study to demonstrate the non inferiority of the immunogenicity of meningococcal vaccine GSK134612 given intramuscularly versus Mencevax™ ACWY given subcutaneously to healthy subjects aged 11 through 17 years - MenACWY-TT-036
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
- 1,025
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 they and/or their parents/guardians can and will comply with the requirements of the protocol.
- •- A male or female between, and including, 11 and 17 years of age at the time of the vaccination.
- •- Written informed assent/consent obtained from the subject/ from the parent or guardian of the subject.
- •-Healthy subjects as established by medical history and clinical examination before entering into the study.
- •-Previously completed routine childhood vaccinations to the best of the subject's/the subject's parent's/guardian's knowledge.
- •-If the subject is female, she must be of non-childbearing potential, or if she is of childbearing potential, she must practice adequate contraception for 30 days prior to vaccination, have a negative pregnancy test and continue such precautions for two months after vaccination.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 1025
- •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 within the last five years.
- •- Previous vaccination with meningococcal polysaccharide conjugate vaccine of serogroup 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.
- •- A family history of congenital or hereditary immunodeficiency, until the immune competence of the potential vaccine recipient is demonstrated.
- •- 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 dose of study vaccine or planned administration during the study period.
- •- Pregnant or lactating female.
- •- History of chronic alcohol consumption and/or drug abuse.
- •- Female planning to become pregnant or planning to discontinue contraceptive precautions.
研究者
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