Study of immunogenicity of Hepatitis B vaccine in Human Immunodeficiency Virus (HIV) infected children: a randomized controlled trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- To compare the efficacy of standard dose vs. double dose of Hepatitis B vaccination in HIV infected Children
研究概览
简要总结
This study is a randomized, single blind, parallel group, single centre trial comparing the efficacy and safety of standard dose vs. double dose of Hepatitis B vaccine given with a schedule of 0,1 and 6 months in 60 human immunodeficiency virus (HIV) infected children conducted at Antiretroviral Therapy (ART) centre and deptt of pediatrics at Moti Lal Nehru Medical College, Allahabad, Uttar Pradesh, India. The primary outcome measure is to compare the efficacy of standard dose vs. double dose of Hepatitis B vaccination in HIV infected children. The secondary outcome measures are to correlate seroprotection after Hepatitis B vaccination in HIV infected children with age, sex of patients, CD4 counts and HAART at vaccination.
研究设计
- 研究类型
- Interventional
- 分配方式
- Permuted block randomization, fixed
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Month(s) 至 18.00 Year(s)（—）
- 性别
- All
入选标准
- •HIV infected children (diagnosed as per NACO guidelines) HBsAg nonreactive.
排除标准
- •Received ≥1 dose of Hepatitis B vaccine in past Critically ill/moribund patients Consent not given.
结局指标
主要结局
To compare the efficacy of standard dose vs. double dose of Hepatitis B vaccination in HIV infected Children
时间窗: 12 weeks after complete vaccination
次要结局
- To correlate seroprotection after Hepatitis B vaccination in HIV infected children with age, sex of patients, CD4 counts and HAART at vaccination(12 weeks after complete vaccination)