Immunogenicity of two dose, two site subcutaneous anti-rabies vaccine as a pre-exposure prophylaxis in children.
试验速览
- 阶段
- 1/2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- 1.Proportion of children with IgG anti rabies virus glycoprotein titres equal to or more than 0.5 EU/ml after 2 doses of subcutaneous Pre-Exposure Rabies Prophylaxis on day 28 in children and adolescents between 2 to 18 years of age.
研究概览
简要总结
Rabies is an infectious zoonotic viral disease that is almost always fatal following the onset of clinical symptoms. It remains a significant cause of mortality in many endemic countries in marginalized populations. World Health Organization (WHO) recommends Intramuscular (IM) or Intradermal (ID) routes of administration for Antirabies vaccine for Preexposure prophylaxis (PrEP) and Postexposure prophylaxis (PEP).Given the importance of preexposure prophylaxis of rabies in resource poor settings, it becomes inevitable to explore a cost friendly and technically feasible route of administration in these settings. Intramuscular route is costly and Intradermal route needs expertise to administer both of which are scarce in a country like India especially in peripheral and rural settings.Subcutaneous route doesn’t require highly skilled personnel as compared to ID route and can be administered even by ground level health care workers.
This is a single arm interventional study in assessing the immunogenicity of two dose two site Subcutaenous route of Antirabies vaccine as a Preexpsoure prophylaxis with primary outcome of protective titres of Antirabies Virus glycoprotein on day 28 and secondary outcome being protective titres on day 90 and proportion of subjects having adverse effects after vaccination.
This Study provides the necessary data in the utility of Subcutaneous route of Antirabies vaccine in resource poor settings.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 2.00 Year(s) 至 18.00 Year(s)（—）
- 性别
- All
入选标准
- •Children and Adolescents between 2 to 18 years presenting to Lok Nayak Hospital OPD for minor ailments.
排除标准
- •Children with prior rabies immunization or history of animal bite.
- •Children with animal bite during the study period.
- •Children with known chronic illnesses.
- •Children receiving any vaccine less than a month ago.
- •Children with known Allergy to any of the components of the vaccine.
结局指标
主要结局
1.Proportion of children with IgG anti rabies virus glycoprotein titres equal to or more than 0.5 EU/ml after 2 doses of subcutaneous Pre-Exposure Rabies Prophylaxis on day 28 in children and adolescents between 2 to 18 years of age.
时间窗: On Day 28+7 | where Day 0 is the day of first dose of Antirabies vaccine
次要结局
- 1. Proportion of children with IgG anti rabies virus glycoprotein titres equal to or more than 0.5 EU/ml after 2 doses of subcutaneous Pre-Exposure Rabies Prophylaxis on day 90 in children & adolescents between 2 to 18 years of age.(2. Proportion of subjects having various kinds of adverse effects after two dose two site subcutaneous preexposure prophylaxis regimen using rabies cell culture vaccine.)
研究者
Suriyanarayanan R
Maulana Azad Medical College