Epidemiologic Surveillance to Assess Trends in Acute Hepatitis A Among Children in Panama
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Occurrence of confirmed acute hepatitis A cases identified in the selected sentinel hospitals during the study period by age group, area of residence and year of surveillance
研究概览
简要总结
The purpose of this study is to collect epidemiological and clinical data to assess the vaccine impact and occurrence of confirmed acute hepatitis A cases in sentinel hospitals after the introduction of Havrix™ into the Expanded Program of Immunization.
详细描述
This is an observational, prospective, multi-centre, sentinel based study in 3 hospitals in Panama. Hospitals are selected based on population density or hepatitis A disease burden.
The Pan American Health Organization (PAHO) definition for a possible case of acute hepatitis A are used for subjects aged between >1 month and <15 years.
Data regarding clinical and epidemiologic information are collected and serum samples are collected to test hepatitis A markers and determine if infection with hepatitis A virus has recently occurred.
Surveillance will be for a period of approximately 2.5 years from the date of study initiation.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 1 Month 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A male or female between >1 month and <15 years of age at the time of enrolment, being referred to any of the 3 participating sentinel hospitals.
- •Subjects with clinical diagnosis of possible acute hepatitis A.
- •Written informed consent obtained from the parent or guardian of the subject.
- •Subjects for whom a blood sample is collected.
排除标准
- •Subjects with confirmed diagnosis of non-viral hepatitis
结局指标
主要结局
Occurrence of confirmed acute hepatitis A cases identified in the selected sentinel hospitals during the study period by age group, area of residence and year of surveillance
时间窗: average time-frame: 2.5 years
次要结局
- Risk factors for confirmed cases of acute hepatitis A(average time-frame: 2.5 years)
- Frequency of different clinical signs and symptoms of hepatitis A(average time-frame: 2.5 years)
- Occurrence of possible and probable cases of acute hepatitis A virus by age group, area of residence and year of surveillance(average time-frame: 2.5 years)