EUCTR2012-005718-20-Outside-EU/EEA进行中（未招募）不适用
A phase 2, open, randomized, controlled, multi-center study to evaluate the safety and immunogenicity of 7 infant immunization schedules of the RTS,S/AS01E candidate vaccine against P. falciparum. - MALARIA-057 PRI
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
- 480
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 infant between 1 and 7 days (inclusive) of age (where day 1 is day of birth).
- •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 par-ents/guardians can and will comply with the requirements of the protocol (e.g. return for follow-up visits) should be enrolled in the study.
- •Born to a mother negative for human immunodeficiency virus (HIV) antibody and hepatitis B surface antigen.
- •Subjects who are born after a normal gestation period (between 37 and 42 weeks) (Gestational age will be de-termined by carrying out a clinical assessment on infants according to the principles set out by Dubowitz (1970) in the first 5 days of life).
- •A minimum weight of 2.5 kg.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 480
- •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 or chronic illness determined by clinical or physical examination and laboratory screening tests including, but not limited to:
- •- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
- •- A family history of congenital or hereditary immu-nodeficiency.
- •- Major congenital defects.
- •- History of any neurological disorders or seizures.
- •Laboratory screening tests out of normal ranges/limits defined per protocol.
- •Previous vaccination with diphtheria, tetanus, pertussis (whole-cell or acellular), Haemophilus influenzae type b, hepatitis B, BCG tuberculosis, measles or oral polio vac-cines.
- •Planned administration/administration of a licensed vaccine (i.e. a vaccine that is approved by one of the following authorities: FDA or EU member state or WHO [with respect to prequalification]) not foreseen by the study protocol within 7 days of the first dose of study vaccine.
- •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 vaccine starting at birth 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 since birth.
- •Simultaneous participation in any other clinical trial.
- •Same-sex twins (to avoid misidentification).
- •Maternal death.
- •History of allergic reactions (significant immunoglobulin E (IgE)-mediated events) or anaphylaxis to previous immunizations.
- •History of allergic disease or reactions likely to be exac-erbated by any component of the vaccine.
- •Children will not be enrolled if any maternal, obstetrical or neonatal event that has occurred might, in the judgment of the investigator, result in increased neonatal/infant morbidity
- •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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