CTRI/2013/05/003670Other4 期
A Phase IV, Non-Inferiority, Observer blind, Randomized Clinical Study Comparing Safety and Immunogenicity of DTP-HB-HIB Vaccination by Disposable-Syringe Jet Injector to Vaccination by Needle and Syringe in Healthy Infants in India.
Serum Institute of India Ltd0 个研究点目标入组 340 人开始时间: 待定最近更新:
试验速览
- 阶段
- 4 期
- 状态
- Other
- 发起方
- 入组人数
- 340
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)Normal healthy infants of age 6-8 weeks at the time of the first vaccination
- •2)Born after a normal gestation period (36-42 weeks).
- •3)Parents/legal guardians of subjects willing to give written informed consent and willing to comply with study protocol.
- •4)Free of obvious health problems as established by medical history and screening evaluation including clinical examination.
- •5)The participant should be the resident of study area.
排除标准
- •1)Infant subject participating in other clinical trial or planned participation in another clinical trial during the present trial period
- •2)Infant with congenital or acquired immunodeficiency, malignancy or receiving immunosuppressive therapy such as systemic corticosteroids therapy.
- •3)Infant with history of allergy or systemic hypersensitivity to any of the vaccine component or history of a life-threatening reaction to the trial vaccine or a vaccine containing the same substances.
- •4)Infant with any chronic illness including hepatic, renal, respiratory, CVS, endocrine and neurological illness.
- •5)Infants who have receive blood or bloodâ??derived products in the past.
- •6)History of diphtheria, tetanus, pertussis, and hepatitis B or Haemophilus influenza type b (confirmed either clinically, serologically or microbiologically).
- •7)Previous history of vaccination against the diphtheria, tetanus, pertussis or Hib or hepatitis B.
- •8)Known history of a bleeding disorder contraindicating intramuscular vaccination
- •9)History of any neurological disorder or history of seizure (febrile or afebrile), or encephalopathy, encephalitis, hypotonic-hyporesponsive episode.
- •10)History of febrile illness at the time of inclusion is a temporary exclusion criterion.
- •11)Acute or chronic, clinically significant pulmonary, endocrine, autoimmune, cardiovascular, metabolic, hepatic or renal functional abnormality, as determined by medical history, and physical examination tests, which in the opinion of the investigator, might interfere with the study objectives
- •12)Infant with any other condition, which, in the opinion of the investigator would jeopardize the safety or rights of the infant participating in the study or making it unlikely the subject could complete the protocol.
研究者
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