PACTR201602001483150尚未招募未知
Immunogenicity and safety study of GSK Biologicals¿ candidate malaria vaccine (SB257049) given at 6, 7.5 and 9 months of age in co-administration with measles, rubella and yellow fever vaccines followed by a booster of the malaria vaccine
适应症
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 入组人数
- 700
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 6 Month(s) 至 6 Month(s)（—）
- 性别
- All
入选标准
- •¿Subjects¿ parent(s)/Legally Acceptable Representative(s) (LAR[s]) who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
- •¿A male or female 6 months of age (from the day the child becomes 6 months of age until the day before the child achieves 7 months of age) at the time of the first vaccination.
- •¿Signed or thumb-printed informed consent obtained from the parent(s)/LAR(s) of the subject. Where parent(s)/LAR(s) are illiterate, the consent form will be countersigned by an independent witness.
- •¿Healthy subjects as established by medical history and clinical examination before entering into the study.
- •¿Previously received three documented doses of diphtheria, tetanus, and whole-cell pertussis, hepatitis B vaccine (DTPwHepB), and a 3-dose course of oral polio vaccine and, if locally recommended, pneumococcal and rotavirus vaccines.
排除标准
- •¿Child in care
- •¿Use of a drug or vaccine that is not approved for that indication other than the study vaccines within 30 days preceding the 1st dose of study vaccine, or planned use during the study period.
- •¿Any medical condition that in the judgment of the investigator would make intramuscular injection unsafe.
- •¿Chronic administration of immunosuppressants or other immunemodifying drugs within 6 months prior to the 1st vaccine dose. For corticosteroids, this will mean prednisone ¿0.5 mg/kg/day, or equivalent. Inhaled and topical steroids are allowed.
- •¿Planned administration/administration of a vaccine not foreseen by the study protocol in the period starting 7 days before the 1st dose of RTS,S/AS01E/measles, rubella and YF vaccines and ending 42 days after last dose of vaccines given at 9 months of age, with the exception of oral polio vaccine which could be given for unforseen public health threat.
- •¿Concurrently participating in another clinical study, at any time during the study period, in which subject has been or will be exposed to an investigational or a noninvestigational vaccine/product.
- •¿Previous vaccination against measles, YF or rubella.
- •¿Previous administration of Vitamin A.
- •¿Moderate or severe malnutrition at screening defined as weight for age Z-score <-2.
- •¿Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
- •¿Family history of congenital or hereditary immunodeficiency.
- •¿History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine(s).
- •¿Major congenital defects or serious chronic illness.
- •¿History of any neurological disorders or seizures.
- •¿Acute disease and/or fever at the time of enrolment.
- •¿Administration of immunoglobulins and/or any blood products within the 3 months preceding the 1st dose of study vaccine or planned administration during the study period
- •¿Same sex twin
- •¿Maternal death
- •¿Previous participation in any other malaria study
研究者
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