CTRI/2013/09/004032
已完成
4 期
A Multicentre, Open label, randomised, phase-IV study to evaluate the immunogenicity & safety of a single booster dose of BEs Tetanus Diphtheria (Td) vaccine (adsorbed) administered to healthy Indian children â?¥7 years, Adolescents and Adults who received primary immunisation as compared with a marketed Diphtheria and Tetanus (Td) vaccine - None
概览
- 阶段
- 4 期
- 干预措施
- 未指定
- 疾病 / 适应症
- 未指定
- 发起方
- Biological E Limited
- 入组人数
- 270
- 状态
- 已完成
- 最后更新
- 4年前
概览
简要总结
暂无简介。
研究者
入排标准
入选标准
- •1\.Written informed consent from the subject or subjectâ??s parent/guardian or subjectâ??s legally acceptable representative
- •2\.Informed assent directly from the child/adolescent aged between \>\=7 to \<18 years in addition to consent from subject or his/her LAR, except when the subject is incapable of providing it because of immaturity or cognitive abilities as judged by the Investigator.
- •3\.Healthy Indian subjects of either gender between \>\=7 to \<18 years in child/adolescent age subset and \>\=18 years of age in adult age subset at the time of vaccination.
- •4\.Good clinical condition established by medical history and physical examination (with no acute disease, infection or high temperature \>103\.5°F \[ \>39\.5°C]).
- •5\.History of previous primary immunisation with DTP vaccine at childhood.
- •6\.Willingness of subject or subjectâ??s parent/guardian or their legally acceptable representative not to participate in any other clinical trial during the course of study.
- •7\.Subject or subjectâ??s parent/guardian or subjectâ??s legally acceptable representative willing to comply with the protocol requirements.
- •8\.Subjects who were not receiving any immunosuppressive therapy.
- •9\.Subjects without contraindications or precautionary circumstances.
排除标准
- •1\.History of Tetanus (TT) or Tetanus with reduced diphtheria (Td) booster vaccination within last 5 years.
- •2\.Subjects with acute disease at the time of enrolment, defined as â??presence of a moderate or severe illnessâ??.
- •3\.Life\-threatening or serious cardiac, respiratory, neurologic, gastrointestinal, hepatic, renal, endocrine, haematologic or immunologic disorder.
- •4\.Subjects with thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injection.
- •5\.Pregnant women and women with childbearing potential not following proven contraceptive methods.
- •6\.Subjects on immunosuppressive or immunostimulant therapy.
- •7\.Any confirmed or suspected immunosuppressive or immunodeficient condition.
- •8\.Known case of hypersensitivity to any of the components of Td vaccine.
- •9\.Known history of any serious adverse reaction/event (SAR/SAE) with previous Tetanus and Diphtheria immunizations.
- •10\.Any criteria, which in the opinion of the Investigator, suggests that the subject would not be compliant with the study protocol.
结局指标
主要结局
未指定
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