EUCTR2015-001539-19-Outside-EU/EEA进行中（未招募）不适用
A Phase IIb randomized, double-blind, controlled study of the safety, immunogenicity and proof-of-concept of RTS,S/AS02D, a candidate malaria vaccine, when incorporated into an Expanded Program on Immunization (EPI) regimen that includes DTPw/Hib in infants living in a malaria-endemic region. - MALARIA-040
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
- 340
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.
- •Written or oral, signed or thumb-printed and witnessed informed consent obtained from the parent(s)/guardian(s) of the child.
- •Subjects who the investigator believes that their par-ents/guardians can and will comply with the requirements of the protocol (e.g. return for follow-up visits).
- •Born to a mother who is HBsAg negative.
- •Born to a mother who is HIV negative.
- •Born after a normal gestation period (between 36 and 42 weeks).
- •Subjects who live within a 5 km radius of a dispensary.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 340
- •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 enrollment.
- •Serious acute or chronic illness determined by clinical or physical examination and laboratory screening tests.
- •Laboratory screening tests out of range for haemoglobin, total white cell count, platelets, alanine aminotransferase and creatinine.
- •Previous vaccination with diphtheria, tetanus, pertussis (whole-cell or acellular), Haemophilus influenzae type b or hepatitis B vaccines.
- •BCG administration within one week of proposed administration 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 within the three months preceding 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.
- •Previous participation in any other malaria vaccine trial.
- •Simultaneous participation in any other clinical trial.
- •Same sex twin.
- •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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