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临床试验/NCT03548233
NCT03548233Unknown不适用

BCG Vaccination Scar Formation in Children Under Five Years :Factors Affecting Its Formation and Subsequent Adverse Effects .

Assiut University0 个研究点目标入组 100 人开始时间: 2021年5月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
100
主要终点
number of children without bcg scar after bcg vaccination and factors that may lead to that nummber of children with adverse effects from bcg vaccine using clinical data about children included in the study

研究概览

简要总结

Study of BCG Vaccination scars of under five years old children . Estimation of the frequency of children without BCG scar after BCG vaccine . Evaluation of factors which may affect scar formation . Tuberculin skin test response in children without BCG scar . Frequency of vaccine adverse effects as injection-site abscess, lymphadenitis, severe local reaction, and disseminated BCG infection.

详细描述

Tuberculosis (TB) is an ancient disease, with evidence of skeletal TB found in mummies in both the Old and New World. The causative agent is Mycobacterium tuberculosis, a fastidious, aerobic, acid-fast bacillus Tuberculosis (TB) remains a major global health problem. It ranks as the second leading cause of death from an infectious disease worldwide, after the human immunodeficiency virus (HIV). The latest estimates by the World Health Organization (WHO) reported that there were 9 million new cases in 2011 and 1.4 million TB deaths . Moreover, it is one of the top 10 causes of global mortality and affects low-income countries in particular. About half a million children (0-14 years old) are ill with TB, and 64,000 children died from the disease in 2011 . In Egypt, TB is considered the third most important public health problem after schistosomiasis and hepatitis C .

TB in children is often missed or overlooked due to non-specific symptoms and difficulties in diagnosis. This has made it difficult to assess the actual magnitude of the childhood TB epidemic, which may be higher than currently estimated.

There is an urgent need for public attention, prioritisation, commitment and funding for this disease that today should never take the life of a child.

Bacillus Calmette-Guérin (BCG) vaccine : a live attenuated vaccine that has been in use since 1921, is the most widely used vaccine worldwide . BCG is efficacious against the most severe forms of tuberculosis (TB) such as tuberculosis meningitis (73% protection) and miliary TB (77% protection) in children younger than 5 years .

It is one of the mandatory vaccines recommended by the ministry of health(MOH) of Egypt.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

年龄范围
6 Months 至 5 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Children between 6 and 60 months of age.

排除标准

  • • Infants with skin lesion on the left forearm.
  • Infant treated with steroids or intravenous immune globulins.
  • Infants with immunodeficiency and malnutrition.
  • Severe sepsis.

结局指标

主要结局

number of children without bcg scar after bcg vaccination and factors that may lead to that nummber of children with adverse effects from bcg vaccine using clinical data about children included in the study

时间窗: one year

bcg vaccination reaction and adverse effects and factors affecting scar formation

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Shimaa Abd elhamid Mahran

principal investigator

Assiut University

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