CTRI/2014/01/004343已完成2 期
A randomized, open label, multicentric, phase II clinical trial to assess the immunogenicity and safety of Measles vaccine (Live) (Freeze-dried) of M/s Cadila Healthcare Ltd. in healthy pediatric subjects aged 9-12 months
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 100
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.Healthy pediatric subjects of either sex aged 9 months to 12 months.
- •2.Informed consent of the parents/guardians and their willingness to be followed up for at least 6 weeks after vaccination of their child.
- •3.Parents/guardians with adequate literacy to fill the diary cards
排除标准
- •1.Subjects with a history of anaphylaxis or serious reactions to vaccines; hypersensitivity to neomycin.
- •2.Subjects with a history of previous measles infection or measles vaccination or if they had been exposed to measles virus within 30 days of trial commencement.
- •3.A history of convulsions, epilepsy or other central nervous system diseases or an acute febrile illness at the time of planned vaccination.
- •4.Any other parenteral vaccine administration within 30 days of initiation of the study or during the study.
- •5.A history of serious chronic illness, major congenital defects, immunosuppression (immunosuppressive illness or therapy).
- •6.Subjects who have received blood products or immunoglobulins parenterally during the preceding 3 months.
- •7.Subjects with any other clinically significant concurrent illness.
研究者
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