PER-120-07已完成未知
Immunogenicity Study of DTaP-IPV-Hep B-PRP~T Combined Vaccine in Comparison to Infanrix®Hexa, at 2-4-6 Months of Age in Healthy Peruvian Infants
适应症
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
- •Infants two months of age (OS at 71 days of age) on the day of inclusion, of both sexes.
- •Born at term (> 37 weeks) and with a birth weight> 2.5 kg.
- •Negative mother for hepatitis B surface antigen (HBsAg) in the last trimester of pregnancy (from> 29 weeks of amenorrhea) or in the 4 weeks after delivery.
- •Informed consent form signed by both parents. If one or both parents are under 18 years of age, the subject´s grandparents must also sign. You must also sign an independent witness if the parents / grandparents are illiterate.
- •Ability to attend all scheduled visits and complete all study procedures.
- •Have received the BCG vaccine between birth and month of life, according to the national immunization schedule.
排除标准
- •Participation in another clinical study in the 4 weeks prior to the first vaccination of the study.
- •Planned participation in another clinical study during the period of this study.
- •Known systemic hypersensitivity to any component of the vaccine, or a history of life-threatening reactions by administration of the study vaccine or a vaccine containing the same substances.
- •Congenital or acquired immunodeficiency, or immunosuppressive therapies such as therapy with long-term systemic corticosteroids (more than 2 weeks) in the last four weeks
- •Chronic disease in a stage that could interfere with the completion or completion of the study.
- •Administration of blood or blood products from birth.
- •Any vaccination applied in the 4 weeks prior to the first vaccination of the study.
- •Any planned vaccination during the study (up to V06), except for study vaccines, rotavirus vaccine and conjugated pneumococcal vaccines.
- •Documented history of infections due to pertussis, tetanus, diphtheria, poliomyelitis, hepatitis B or Haemophilus influenzae type b (clinically, serologically or microbiologically confirmed).
- •Prevaccination against pertussis, tetanus, diphtheria, polio, hepatitis B or Haemophilus influenzae type b infections.
- •Personal or mother´s known background of seropositive status to human immunodeficiency virus, hepatitis B or hepatitis C.
- •Known thrombocytopenia or bleeding disorder for which an FM application is contraindicated.
- •History of seizures.
- •Febrile illness (temperature> 38.0 ° C) or acute on the day of inclusion.
研究者
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