EUCTR2012-005716-26-Outside-EU/EEA进行中（未招募）不适用
A phase III, double blind (observer-blind), randomized, controlled multi-center study to evaluate, in infants and children, the efficacy of the RTS,S/AS01E candidate vaccine against malaria disease caused by P. falciparum infection, across diverse malaria transmission settings in Africa. - MALARIA-055 PRI
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
- 15,458
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
- •All subjects must satisfy the following criteria at study entry:
- •-A male or female child of 5-17 months (inclusive) of age at time of first vaccination, or between 6-12 weeks (inclusive) of age at time of first vaccination and NOT have already received a dose of vaccine against diphtheria, tetanus or pertussis or Hemophilus influenzae type B and must be > 28 days of age at screening.
- •-Signed informed consent or thumb-printed and witnessed informed consent obtained from the parent(s)/guardian(s) of the child.
- •-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.
- •All subjects must satisfy the following criteria at the start of the extension phase:
- •-Subjects who were enrolled and who received at least one vaccine dose in the primary trial phase.
- •-Subjects who were present for Visit 35 on or before 30 Sep-tember 2013.
- •-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.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 15458
- •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
- •The following criteria should be checked at the time of study entry. If any apply, the subject must not be included in the study:
- •-Acute disease at the time of enrolment (acute disease is de-fined as the presence of a moderate or severe illness with or without fever). All vaccines can be administered to persons with a minor illness such as diarrhea, mild upper respiratory infection with or without low-grade febrile illness, i.e. axillary temperature < 37.5°C).
- •-Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
- •-Anemia defined as: hemoglobin < 5.0 g/dL or hemoglobin < 8 g/dL associated with clinical signs of heart failure or severe respiratory distress.
- •-Major congenital defects.
- •-History of allergic reactions, significant IgE-mediated events or anaphylaxis to previous immunizations.
- •-Children with a past history of a neurological disorder or atypical febrile seizure (a febrile seizure is atypical if it meets one of the following criteria: not associated with fever; lasts > 5 minutes; focal (not generalized); followed by transient or persistent neurological abnormality; occurs in a child < 6 months of age).
- •Children with malnutrition requiring hospital admission.
- •Children currently meeting the criteria for HIV disease of Stage III or Stage IV severity as defined by the World Health Organi-zation [WHO, 2005]. NB: a previous history of having Stage III or Stage IV HIV disease is NOT an exclusion criterion.
- •-History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
- •-Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to a drug or vaccine that is not licensed for that indication (by one of the following authorities: FDA or EU member state or WHO [with respect to prequalification]) with the exception of studies with the objective of improving the drug treatment or clinical management of severe malaria disease.
- •-Use of a drug or vaccine that is not approved for that indication (by one of the following authorities: FDA or EU member state or WHO [with respect to prequalification]) other than the study vaccines within 30 days preceding the first dose of study vaccine, or planned use during the study period.
- •-Previous participation in any other malaria vaccine trial.
- •-Receipt of a vaccine within the preceding 7 days
- •-Any other findings that the investigator feels would increase the risk of having an adverse outcome from participation in the trial.
- •-Any other findings that the investigator feels would result in data collected being incomplete or of poor quality.
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