EUCTR2016-000290-20-Outside-EU/EEA进行中（未招募）1 期
Phase IIb randomized, open-label, controlled, multi-center study of the efficacy, safety and immunogenicity of GSK Biologicals’ candidate malaria vaccine RTS,S/AS01E evaluating schedules with or without fractional doses, early Dose 4 and yearly doses, in children 5-17 months of age living in sub-Saharan Africa - MALARIA-094
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 1,500
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’ parent(s)/LAR(s) who, in the opinion of the investigator, can and will comply with the require-ments of the protocol (e.g. return for follow-up visits).
- •Signed or thumb-printed and witnessed informed consent obtained from the parent(s)/LAR(s) of the subject prior to performance of any study specific procedure. Where parent(s)/LAR(s) are illiterate, the consent form will be countersigned by an independ-ent witness.
- •A male or female between, and including, five and 17 months of age at the time of the first vaccination.
- •Healthy subjects as established by medical history and clinical examination before entering into the study.
- •Previously received three documented doses of diph-theria, tetanus, pertussis, hepatitis B vaccine (DTPHepB), and at least three doses of oral polio vaccine.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 1500
- •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
- •Child in care.
- •Use of a drug or vaccine that is not approved for that indication (by one of the following regulatory authorities: Food and Drug Administration [FDA; USA] or European Union member state or WHO [with respect to prequalifi-cation]) other than the study vaccines during the period starting 30 days before the first dose of study vaccines (Day -29 to Day 0), or planned use during the study period.
- •Any medical condition that in the judgment of the investigator would make intramuscular injection unsafe.
- •Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs during the period starting six months prior to the first vaccine dose. For corticosteroids, this will mean prednisone (0.5 mg/kg/day (for pediatric subjects) or equivalent. Inhaled and topical steroids are allowed.
- •Planned administration/administration of a vaccine not foreseen by the study protocol in the period starting seven days before each dose and ending seven days after each dose of vaccine administration.
- •Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational vaccine/product (pharmaceutical product or device).
- •Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
- •Family history of congenital or hereditary immunodeficiency.
- •History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccines.
- •History of anaphylaxis post-vaccination.
- •History of any, or documented, serious adverse reaction to rabies vaccination.
- •Contraindication to rabies vaccination (Rabipur is contra-indicated in subjects with an history of a severe hyper-sensitivity to any of the ingredients in the vaccine. Note that the vaccine contains polygeline and residues of chicken proteins, and may contain traces of neomycin, chlortetracycline and amphotericin B).
- •Major congenital defects.
- •Serious chronic illness.
- •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).
- •Acute disease and/or fever at the time of enrolment.
- •?Fever is defined as temperature = 37.5C/99.5F for oral, axillary or tympanic route, or = 38.0C/100.4F for rectal route.
- •?Subjects with a minor illness (such as mild diar-rhea, mild upper respiratory infection) without fever may, be enrolled at the discretion of the investigator.
- •Administration of immunoglobulins and/or any blood products during the period starting three months before the first dose of study vaccine or planned administration during the study period.
- •Moderate or severe malnutrition at screening defined as weight for age or weight for height Z-score < -2.
- •Hemoglobin concentration < 8 g/dl at screening.
- •Same sex twins (to avoid misidentification).
- •Maternal death.
- •Prior receipt of an investigational malaria vaccine.
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