CTRI/2024/06/069168尚未招募不适用
Immunogenicity of Single Dose Intradermal Pre-Exposure Rabies Prophylaxis Regimen in Children.
Maulana Azad Medical College and Lok Nayak Hospital1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年6月25日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Proportion of subjects with IgG anti rabies virus glycoprotein titres equal to or more than 0.5 EU/ml 28 days after single dose of Intradermal Pre exposure Rabies Prophylaxis.
研究概览
简要总结
The study is a single arm interventional study titled IMMUNOGENICITY OF SINGLE DOSE INTRADERMAL PRE-EXPOSURE RABIES PROPHYLAXIS REGIMEN IN CHILDREN 1-18 years of age in 40 patients and will be conducted at Maulana Azad Medical college, New delhi.
The primary outcome would be to find out the Proportion of subjects with IgG anti rabies virus glycoprotein titres equal to or more than 0.5 EU/ml 28 days after single dose of Intradermal Pre exposure Rabies Prophylaxis.
The Secondary Outcomes would be to find out-
- Proportion of subjects with IgG anti rabies virus glycoprotein titres equal to or more than 0.5 EU/ml 180 days after single dose of Intradermal Pre exposure Rabies Prophylaxis.
- Proportion and profile of adverse effects in children, following single dose intradermal pre-exposure rabies prophylaxis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
入排标准
- 年龄范围
- 1.00 Year(s) 至 18.00 Year(s)（—）
- 性别
- All
入选标准
- •Children and adolescents aged 1-18 years from OPD / with minor illnesses.
排除标准
- •1.History of receipt of any rabies vaccine in the 2.Past History of animal bite.
- •Previous severe allergic reaction to any of the vaccine components.
- •4.Known history of autoimmune disease, immunodeficiency disorders or chronic diseases.
- •5.History of receipt of any vaccine within 1 month.
- •6.History of dog bite during the study period.
结局指标
主要结局
Proportion of subjects with IgG anti rabies virus glycoprotein titres equal to or more than 0.5 EU/ml 28 days after single dose of Intradermal Pre exposure Rabies Prophylaxis.
时间窗: Baseline
次要结局
- 1.Proportion of subjects with IgG anti rabies virus glycoprotein titres equal to or more than 0.5 EU/ml 180 days after single dose of Intradermal Pre exposure Rabies Prophylaxis..(2.Proportion & profile of adverse effects in children, following single dose intradermal pre-exposure rabies prophylaxis)
研究者
Dr Kanvi Sharma
Maulana Azad Medical College
研究点 (1)
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