Long Term Hepatitis A Virus (HAV) Antibody Persistence in Children Vaccinated With 1 Dose and Those Vaccinated With 2 Doses of Havrix in Panama
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,201
- 试验地点
- 4
- 主要终点
- Number of Subjects With Anti-hepatitis A Virus (HAV) Seropositivity Status at Approximately 8 Years Following Last Administered Havrix Dose
研究概览
简要总结
The purpose of this study is to evaluate the persistence of hepatitis A antibodies, approximately 8 years and 10 years post vaccination with the complete series of Havrix (2 doses) and the partial series completion (1 dose).
详细描述
The study comprises of two independent cross-sectional surveys (Year 8 and Year 10). The first cross-sectional serosurvey will evaluate the long term persistence of immunity approximately 8 years post vaccine administration and the second cross-sectional study will evaluate long term persistence, approximately 10 years post vaccine administration.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 8 Years 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects whose parent(s)/ LAR(s), in the opinion of the investigator, can and will comply with the requirements of the protocol.
- •Written informed assent/consent obtained from the subject or subject's parent(s)/ LAR(s) of the subject.
- •Available HAV vaccination records.
- •Children who have received either 1 or two doses of Havrix at selected health centres of Panama.
- •Children with ≥ 7 years and < 10 years between last dose and Persistence Visit 1 (Year 8) and children ≥ 10 years and < 13 years between last dose and Persistence Visit 1' (Year 10).
排除标准
- •Child in care.
- •Subjects with history of vaccination with other hepatitis A vaccines other than Havrix.
- •Subjects with known past history of hepatitis A infection, both without vaccination and after they received the last dose of Havrix (1 dose or the complete 2 dose schedule).
结局指标
主要结局
Number of Subjects With Anti-hepatitis A Virus (HAV) Seropositivity Status at Approximately 8 Years Following Last Administered Havrix Dose
时间窗: At approximately 8 years after the last administered vaccine dose
Subjects are defined as being seropositive if their anti-HAV antibody concentration is equal to or above (≥) 15 milli-international unit/milliliter (mIU/mL).
Number of Subjects With Anti-HAV Seropositivity Status at Approximately 10 Years Following Last Administered Havrix Dose
时间窗: At approximately 10 years after the last administered vaccine dose
Subjects are defined as being seropositive if their anti-HAV antibody concentration is equal to or above (≥) 15 mIU/mL.
次要结局
- Anti-HAV Antibody Concentrations at Approximately 8 Years Following Last Administered Havrix Dose(At approximately 8 years after the last administered vaccine dose)
- Anti-HAV Antibody Concentrations at Approximately 10 Years Following Last Administered Havrix Dose(At approximately 10 years after the last administered vaccine dose)
- Number of Subjects With Anti-HAV Antibody Concentration ≥ 15 mIU/mL at Approximately 8 Years Following Last Administered Havrix Dose - Exploration of Non-inferiority of the 1-dose Schedule Compared to the 2-dose Schedule of Havrix(At approximately 8 years after the last administered vaccine dose)
- Number of Subjects With Anti-HAV Antibody Concentrations ≥ 15 mIU/mL at Approximately 10 Years Following Last Administered Havrix Dose - Exploration of Non-inferiority of the 1-dose Schedule Compared to the 2-dose Schedule of Havrix(At approximately 10 years after the last administered vaccine dose)