CTRI/2016/11/007434已完成1 期
Safety and Immunogenicity of a Hexavalent Vaccine (DTwP-HepB-Hib-IPV) in Toddlers and Infants.
Shantha Biotechnics Pvt Ltd a Sanofi Company0 个研究点目标入组 195 人开始时间: 待定最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 195
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
- •For Toddlers
- •1. Children between 15-18 months of age whose Parents/ LAR has signed the written informed consent prior to the study inclusion.
- •2. Children with good general health as determined by the medical history, physical examination and clinical judgment of the investigator.
- •3. Children who have completed primary immunization series against
- •Diphtheria, tetanus, pertussis, hepatitis b, Haemophilus influenza type b infections and poliomyelitis and have not received the booster dose scheduled at 15-18 months of age.
- •4. Subject and Parent/LAR are able to attend all scheduled visits and to comply with all study procedures.
- •For Infants
- •1. Infants between 6-8 weeks of age (42 to 56 days, both days inclusive) on the day of enrollment.
- •2. Born at full term of pregnancy (more than or equal to 37 weeks) with a birth weight more than or equal to 2.5 kg.
- •3. Infants who have received the birth dose of OPV, Hep B vaccine and BCG vaccine at least 4 weeks before the first trial vaccination.
- •4. Informed consent form signed by Parent or LAR.
- •5. Subject and Parent/LAR are able to attend all scheduled visits and to comply with all study procedures.
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.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.
- •3.Chronic illness at a stage that could interfere with trial conduct or completion, in the opinion of the Investigator.
- •4.Blood or blood-derived products received in the 30 days or current or planned administration during the trial.
- •5.History of diphtheria, pertussis, tetanus, Haemophilus influenzae type b, or Hep B, or poliomyelitis, infection(s) (confirmed either clinically, serologically or microbiologically).
- •6.Known personal or maternal history of Human Immunodeficiency Virus (HIV), hepatitis B (HBsAg) or hepatitis C seropositivity.
- •7.Known thrombocytopenia, as reported by the parent/ LAR.
- •8.Bleeding disorder or receipt of anticoagulants in the 3 weeks preceding inclusion.
- •9.Moderate or severe acute illness/infection (according to Investigator judgment) on the day of vaccination or febrile illness on the day of inclusion
- •10.Identified as a natural or adopted child of the Investigator, relatives or employee with direct involvement in the proposed study.
- •11.History of seizures or encephalopathy.
- •Specific to Toddlers:
- •12.Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within preceding 6 months or long-term systemic corticosteroids therapy
- •13.Receipt of any vaccine in the 4 weeks preceding the trial vaccination or planned receipt of any vaccine during trial participation.
- •Specific to Infants
- •14. Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy; or long-term systemic corticosteroids therapy.
- •15. Receipt of any vaccine in the 4 weeks preceding the first trial vaccination.
- •16. Planned receipt of any other vaccine within the period from 8 days before to 8 days after each trial vaccination.
- •17. Previous vaccination (except the birth dose of OPV and Hep B vaccine) or planned receipt of any vaccine against the diphtheria, tetanus, pertussis, hepatitis B disease, Haemophilus influenzae type b infection or poliomyelitis, apart from trial vaccines in the 4 weeks following trial vaccination.
研究者
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