CTRI/2011/091/000099已完成4 期
Sero-surveillance to assess Rubella susceptibility and assessment of immunogenicity andreactogenicity of Rubella vaccine (R-Vac®) in female students aged 18-24 years, of Symbiosis International University ( SIU).
Serum Institute of India Research Foundation Pune Hadapsar Pune0 个研究点目标入组 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
- 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. Female students aged 18-24 years at the time of enrollment.
- •2. Free of obvious health problems as established by medical history & clinical examination
- •before entering into the study.
- •3. Written, Explained, Signed informed consent.
排除标准
- •1. Use of any investigational or non-registered drug or vaccine other than the study vaccine during the study period.
- •2. Administration of immunoglobulin or any blood products in last 3 months.
- •3. History of significant and persistent hematological, hepatic, renal, cardiac, respiratory,
- •neurological disorders or seizure.
- •4. Axillary temperature ≥ 38.5 ° C.
- •5. Confirmed immunosuppression including HIV infection.
- •6. Major congenital or hereditary immunodeficiency.
- •7. Simultaneous participation in any other clinical study.
研究者
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