CTRI/2013/09/003997招募中3 期
Immunogenicity and Safety of Sanofi Pasteurâ??s DTaP-IPV-Hep B-PRP-T Combined Vaccine Given at 6, 10 and 14 Weeks of Age in Infants from 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: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 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
入排标准
入选标准
- •1) Aged between 42-56 days (6 to 8 weeks) on the day of inclusion.
- •2) Born at full term of pregnancy (greater or equal to 37 weeks) and with a birth weight greater or equal to 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 hepatitis B surface antigen (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 oral poliovirus vaccine (OPV) from birth as per national recommendations.
排除标准
- •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 Bacillus 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.
- •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 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) History of diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B, or Hib infections (confirmed either clinically, serologically or microbiologically).
- •7) Known personal or maternal history of Human Immunodeficiency Virus (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 greater or equal to 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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