BCG Vaccination Scar Formation in Children Under Five Years :Factors Affecting Its Formation and Subsequent Adverse Effects .
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
- 是
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
Shimaa Abd elhamid Mahran
principal investigator
Assiut University
