EUCTR2016-002089-29-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 Given at 6, 10, and 14 Weeks of Age in Infants in India Who Previously Received a Dose of Hepatitis B Vaccine at Birth
Sanofi Pasteur SA0 个研究点目标入组 177 人开始时间: 2016年5月12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
- 177
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 between 42-56 days (6 to 8 weeks) on the day of inclusion
- •2) Born at full term of pregnancy (=37 weeks) and with a birth weight =2.5 kg
- •3) Informed consent form signed by the parent(s) or any 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 HBsAg seronegative mother (documented laboratory result of HBsAg assay from maternal blood sample performed during
- •last trimester of pregnancy available)
- •6) Have received one documented dose of Hep B vaccine and OPV from birth as per national recommendations
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 177
- •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 another clinical trial 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 the first trial vaccination (except BCG vaccine) or planned receipt of any other
- •vaccine within the period from 8 days before to 8 days after each subsequent trial vaccination
- •3) Previous vaccination against the diphtheria, tetanus, pertussis, poliomyelitis (expect the birth dose of OPV as per national
- •recommendations) and hepatitis B (except the birth dose of Hep B vaccine) diseases or Hib infection with the trial vaccine or another
- •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) History of diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B, or Hib infections (confirmed either clinically, serologically or
- •microbiologically)
- •7) Known personal or maternal history of HIV or hepatitis C seropositivity
- •8) 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
- •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 (axillary
- •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)
- •14) Identified as a natural or adopted child of the Investigator, relatives or employee with direct involvement in the proposed study
- •15) History of seizures
研究者
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