EUCTR2012-005695-34-Outside-EU/EEA进行中（未招募）不适用
A Phase II randomized, open, controlled study of the safety and immunogenicity of GlaxoSmithKline Biologicals’ candidate Plasmodium falciparum malaria vaccine RTS,S/AS01E, when incorporated into an Expanded Program on Immunization (EPI) regimen that includes DTPwHepB/Hib, OPV, measles and yellow fever vaccination in infants living in malaria-endemic regions. - MALARIA-050
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
- 511
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
- •-A male or female infant between 6 and 10 weeks of age at the time of first vaccination.
- •-Signed or thumb-printed informed consent obtained from the parent(s)/guardian(s) of the child. Where parent(s)/guardian(s) are illiterate, the consent form will be countersigned by a witness.
- •-Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol (e.g. return for follow-up visits) should be enrolled in the study.
- •-Subjects who have received one previous dose of OPV and BCG.
- •-Subjects who are born after a normal gestation period (between 36 and 42 weeks).
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 511
- •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
- •-Acute disease at the time of enrolment.
- •-Serious acute or chronic illness determined by clinical or physical examination and laboratory screening tests.
- •-Laboratory screening tests out of range, specifically: ALT and creatinine above acceptable limit; Hemoglobin, Platelet count and Total white cell count below acceptable limit.
- •-Previous vaccination with diphtheria, tetanus, pertussis (whole-cell or acellular), Hemophilus influenzae type b or hepatitis B vaccines.
- •-BCG administration within one week of proposed administration of a study vaccine.
- •-OPV administration within four weeks of proposed administra-tion of a study vaccine.
- •-Planned administration/administration of a vaccine not foreseen by the study protocol within 30 days of the first dose of vaccine(s).
- •-Use of any investigational or non-registered drug or vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period.
- •-Administration of immunoglobulins, blood transfusions or other blood products since birth to the first dose of study vaccine or planned administration 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.
- •-Simultaneous participation in any other clinical trial.
- •-Twins (to avoid misidentification).
- •-Maternal death.
- •-History of allergic reactions (significant IgE-mediated events) or anaphylaxis to previous immunizations.
- •-History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
- •-Any other findings that the investigator feels would increase the risk of having an adverse outcome from participation in the trial.
研究者
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