PER-064-05已完成未知
ARGE SCALE ASSAY OF A COMBINED VACCINE DTAP-IPV-IPV-HB-PRP-T COMPARED WITH TRITANRIX-HEPB / HIB ™ AND AN OPV VACCINE ADMINISTERED AT 2, 4 AND 6 MONTHS OF AGE IN LATIN AMERICAN CHILDRE
试验速览
- 阶段
- 未知
- 状态
- 已完成
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
- 0 至 0（—）
入选标准
- •1) Children 2 months of age (50 to 71 days of age inclusive) on the day of inclusion.
- •2) Born at full term (> 37 weeks) and with a birth weight> 2.5 kg.
- •3) Informed consent form signed by one or both parents or by the legal representative.
- •4) Possibility of attending all scheduled visits and complying with all study procedures.
- •5) Compliance with the national immunization schedule for the 2 first months of life.
排除标准
- •1) Participation in another clinical study in the 4 weeks prior to the first vaccination of the study.
- •2) Participation planned in another clinical study during the present clinical study.
- •3) Congenital or acquired immunodeficiency, immunosuppressive therapies.
- •4) Individuals from the child s environment who have congenital or acquired immunodeficiency.
- •5) Systemic hypersensitivity to any of the components of the vaccine, or a history of life-threatening reactions by administration of the study vaccine or a vaccine containing the same substances.
- •6) Chronic disease in a stage that could interfere with the completion or completion of the study.
- •7) Administration of blood or blood products from birth.
- •8) Any vaccination applied in the 4 weeks prior to the first vaccination of the study.
- •9) Vaccination planned in the 4 weeks following the vaccination of the study.
- •10) Documented history of infections due to pertussis, tetanus, diphtheria, polio, Haemophilus influenzae type b or hepatitis B.
- •11) Mother with a known seropositive result of HTV or hepatitis C, or known carrier of hepatitis B surface antigen.
- •12) Prevaccination against infections due to pertussis, tetanus, diphtheria, poliomyelitis or Haemophilus influenzae type b.
- •13) Coagulopathy, thrombocytopenia or bleeding disorder for which an IM application is contraindicated.
- •14) History of seizures.
- •15) Febrile or acute illness at the day of inclusion.
研究者
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