EUCTR2016-002873-36-Outside-EU/EEA进行中（未招募）1 期
Immunogenicity and Safety of Sanofi Pasteur's DTaP-IPV-Hep B-PRP-T Combined Vaccine at 2, 4, and 6 Months of Age versus Sanofi Pasteur's DTaP-IPV//PRP~T Combined Vaccine at 2, 4, and 6 Months of Age + Hep B Vaccine at 1 and 6 Months of Age, in South Korean Infants Primed with Hep B at Birth
Sanofi Pasteur SA0 个研究点目标入组 310 人开始时间: 2016年7月8日最近更新:
适应症
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
- 310
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
- •An individual must fulfill all of the following criteria in order to be eligible for trial enrollment:
- •1) Aged 30 to 40 days on the day of the first study visit
- •2) Born at full term of pregnancy (=37 weeks) and with a birth weight =2.5 kg
- •3) Informed consent form has been signed and dated by the parent(s) or other legally acceptable representative
- •4) Subject and parent/legally acceptable representative are able to attend all scheduled visits and to comply with all trial procedures
- •5) Born to known hepatitis B surface antigen (HBsAg) seronegative mother: documented HBsAg negative status during the last trimester of pregnancy (or post-birth) or documented HBsAg negative and HBsAb positive status before last trimester of pregnancy
- •6) Have received one documented dose of Hep B vaccine at birth according to the national recommendations
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 310
- •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
- •An individual fulfilling any of the following criteria is to be excluded from trial enrollment:
- •1) Participation in the 4 weeks preceding the trial inclusion or planned participation during the present trial period in another clinical trial
- •investigating a vaccine, drug, medical device, or medical procedure
- •2) Receipt of any vaccine in the 4 weeks preceding any trial vaccination (except Bacille Calmette Guerin [BCG] vaccine) or planned receipt of any vaccine in the 8 days following any trial vaccination
- •3) Previous vaccination against diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B (except the dose of Hep B vaccine given at birth) diseases or Haemophilus influenzae type b infection with either the trial vaccine or another vaccine
- •4) Past or current receipt of immune globulins, blood or blood-derived products or planned administration during the trial
- •5) Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, since birth; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks since birth)
- •6) Known personal or maternal history of Human Immunodeficiency Virus (HIV) or hepatitis C seropositivity
- •7) History of diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B, or Haemophilus influenzae type b infection, confirmed either clinically,
- •serologically, or microbiologically
- •8) Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccines used in the trial or to a vaccine containing any of the same substances
- •9) Known thrombocytopenia, as reported by the parent/legally acceptable representative
- •10) Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular vaccination
- •11) In an emergency setting, or hospitalized involuntarily
- •12) Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with trial conduct or completion
- •13) Moderate or severe acute illness/infection (according to investigator judgment) on the day of vaccination or febrile illness (temperature =38.0°C). A prospective subject should not be included in the study until the condition has resolved or the febrile event has subsided.
- •14) Identified as a natural or adopted child of the Investigator or employee with direct involvement in the proposed study
- •15) History of seizures
研究者
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