EUCTR2013-003267-55-PL进行中（未招募）1 期
An international, multicenter, open-label, one-arm study in 150 infants vaccinated with a 3-dose primary series of the DTaP-IPV-Hep B-PRP-T combined vaccine in the Russian Federation and Poland.
Sanofi Pasteur SA0 个研究点目标入组 150 人开始时间: 2015年7月28日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 150
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
- •1) Male and female aged 42 to 56 days (between 6 and 8 weeks of age) on the day of inclusion
- •2) Have received one dose of Hep B vaccine at birth (documented according to national recommendations)
- •3) Born at full term of pregnancy (= 37 weeks) and with a birth weight = 2.5 kg
- •4) Born to known Hep B surface antigen (HBsAg) seronegative mother (documented laboratory result of HBsAg assay from the maternal blood sample during pregnancy is available)
- •5) Informed consent form signed and dated by the parent(s) or any other legally acceptable representative (if applicable*)
- •6) Subject and parent/legally acceptable representative (if applicable) are able to attend all scheduled visits and to comply with all trial procedures
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 150
- •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
- •1) Previous vaccination against the diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B diseases (accept Hep B given at birth), or Haemophilus Influenzae type B infection with the trial vaccine or another vaccine
- •2) Acute illness of any severity on the day of inclusion or febrile illness (rectal temperature = 38°C) on the day of inclusion (a prospective subject should not be included in the study until the condition has resolved or the febrile event has subsided
- •3) Participation in the 4 weeks preceding the first trial vaccination or planned participation during the present trial period in another clinical trial investigating a vaccine, drug, medical device, or medical procedure
- •4) Receipt of any vaccine in the 4 weeks preceding the first trial vaccination (except Bacille Calmette Guerin [BCG] vaccine) or planned receipt of any other vaccine within the period from 8 days before to 8 days after each subsequent trial vaccination
- •5) Past or current receipt of immune globulins, blood or blood-derived products or planned administration during the trial
- •6) Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 3 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months)
- •7) History of diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B, or Haemophilus influenzae type b infections (confirmed either clinically, serologically or microbiologically)
- •8) Known personal or maternal history of HIV or hepatitis C seropositivity
- •9) Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the trial vaccine or a vaccine containing the same substances (the list of vaccine components is included in the Investigator’s Brochure/Summary of Product Characteristics)
- •10) Known thrombocytopenia in medical history, contraindicating intramuscular vaccination
- •11) Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular vaccination
- •12) In an emergency setting, or hospitalized involuntarily
- •13) Chronic illness in medical history that, in the opinion of the investigator, is at a stage where it might interfere with trial conduct or completion (may include, but is not limited to, cardiac, renal or auto-immune disorders, diabetes, psychomotor diseases, and known congenital or genetic diseases)
- •14) Identified as a natural or adopted child of the Investigator, relatives or employee with direct involvement in the proposed study
- •15) Known history of seizures
- •16) Known uncontrolled neurologic disorder (including epilepsy)
研究者
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