CTRI/2009/091/000615已完成4 期
A Phase IV, Open Label, Randomized, Parallel Group, Multicentre Clinical Study To Determine And Compare Reactogenicity Of Pentavac Vaccine (DTP-HB+Hib) of SIIL with Tritanrix-HB-HIB of GSK in Indian infants.
Serum Institute of India Research Foundation0 个研究点目标入组 1,500 人开始时间: 待定最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 1,500
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 vaccination2)Parents/Legal Guardian of subject willing to give written informed consent 3)Parents/Legal Guardian 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 2) Infant with congenital or acquired immunodeficiency, malignancy or receiving immunosuppressive therapy 3)Infant with history of allergy or systemic hypersensitivity to any of the vaccine component 4)Infant with chronic illness. 5)Infant who receive blood or blood?derived products in the past. 6)Known history of a bleeding disorder. 7)History of any neurological disorder or history of seizure (febrile or afebrile), or encephalopathy, encephalitis, hypotonic-hyporesponsive episode.
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