CTRI/2018/12/016692已完成3 期
Phase III Safety and Immunogenicity of an Investigational versus the Licensed Formulation of the Pentavalent Vaccine (DTwP-HepB-Hib) SHAN 5�® when administered as Three Dose Primary Series at 6-8, 10-12 and 14-16 Weeks of Age in Healthy Indian Infants and Safety and Immunogenicity of the Investigational SHAN 5�® Formulation when administered as a Single Booster Dose at 12-24 Months of Age
Shantha Biotechnics Pvt Ltd0 个研究点目标入组 460 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 460
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 Infants (Stage 1):
- •1.Infants between 6-8 weeks of age on the day of enrollment.
- •2.Healthy infants, born at full term of pregnancy (not less than 37 weeks) with a birth weight not less than 2.5 kg
- •3.Informed consent form signed by the parent or by the legally acceptable representative (LAR).
- •4.Subjects and Parent/LAR are able to attend all scheduled visits and to comply with all study procedures.
- •For Toddlers (Stage 2):
- •1.Toddlers aged between 12-24 months of age on the day of enrollment and had received either the investigational or the licensed SHAN 5Ã?® vaccine formulation at 6-8, 10-12 and 14-16 weeks of age during stage 1 of the trial.
- •2.Informed consent form signed by the parent or by the LAR.
- •3.Subjects 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
- •2.Receipt of any vaccine in the 4 weeks preceding the first trial vaccination (except BCG, birth dose OPV and birth dose of Hep B vaccine).
- •3.Planned receipt of any other vaccine within the period from 8 days before to 8 days after each trial vaccination except OPV.
- •4.For Stage 1 only: Previous vaccination against the diphtheria, tetanus, pertussis, hepatitis B (except the birth dose of Hep B vaccine) or Haemophilus influenza type b infection with the trial vaccine or another vaccine.
- •5.For Stage 2 only: Previous booster dose vaccination against diphtheria, tetanus, pertussis, hepatitis B, or Haemophilus influenza type b infection with the trial vaccine or another vaccine.
- •6.Past or current receipt of immunoglobulins, blood or blood-derived products or planned administration during the trial.
- •7.Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, or long-term systemic corticosteroid therapy.
- •8.History of diphtheria, tetanus, pertussis, hepatitis B, or Haemophilus influenza type b infections.
- •9.Known personal or maternal history of HIV or hepatitis B seropositivity.
- •10.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.
- •11.Known thrombocytopenia.
- •12.Bleeding disorder or receipt of anticoagulants in the 3 weeks preceding inclusion, contradicting intramuscular vaccination.
- •13.Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with trial conduct or completion.
- •14.Moderate or severe acute illness/infection (according to investigator judgment) on the day of vaccination or febrile illness on the day of inclusion.
- •15.Identified as a natural or adopted child of the Investigator, relatives or employee with direct involvement in the proposed study.
- •16.Subject with definite seizure disorder and getting anticonvulsant therapy.
研究者
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