CTRI/2009/091/000616已完成4 期
A Phase IV, Open label, Randomised, Comparative, Parallel group, Clinical Study to Evaluate the immunogenicity and Safety of two different formulations of Haemophilus Influenzae Type-B Vaccine (SII HibPRO) of Serum Institute of India Limited in Indian Infants.
Serum Institute of India Ltd0 个研究点目标入组 218 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
- 218
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 first vaccination 2) Parents of subject willing to give written informed consent 3) Free of obvious health problems as established by medical history and physical examination.
排除标准
- •1) Infant subject participating in other clinical trial. 2) Infant with congenital or acquired immunodeficiency, malignancy or receiving immunosuppressive therapy. 3) Infant with history of allergy or systemic hypersensitivity. 4) Infant with any chronic illness. 5)Infant who received blood or blood derived products in the past. 6) Known history of a bleeding disorder 7) Any other condition that in the opinion of the investigator would jeopardize the safety or rights of the subject participating in the study or making it unlikely the subject could complete the protocol 8) History of febrile illness is a temporary exclusion criterion.
研究者
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