Study Interchangeability Hep-B Vaccine Administered at Birth Dose
Randomized, Double-Blind, Interchangeability Study of In-House Recombinant Hepatitis B (Bio Farma) at Birth Dose Followed by RRegistered DTwP-HepB-IPV-Hib (HEXASIIL) Vaccine in Indonesian Infants
This trial is a randomized, double-blind, two arms parallel groups, prospective intervention study.
研究概览
详细说明
This trial is a randomized, double-blind, two arms parallel groups, prospective intervention study.
Approximately 270 newborns will be enrolled in this trial, divided into 2 arms, with the ratio 1:1. The subject will receive one dose of In-House Recombinant Hepatitis B at birth or registered monovalent Hepatitis B as a control then followed by registered DTwP-HepB-IPVHib (HEXASIIL) vaccine
研究类型
注册 (估计的)
阶段
- 第三阶段
联系人和位置
学习联系方式
- 姓名：Rini Mulia Sari, MD
- 电话号码：14102 +622033755
- 邮箱：rini.mulia@biofarma.co.id
研究联系人备份
- 姓名：Mita Puspita, MD
- 电话号码：5045 +622033755
- 邮箱：mita.puspita@biofarma.co.id
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Healthy, full term, newborn infants.
- Infant born between 37-42 weeks of pregnancy.
- Infant weigh between 2500 - 4000 gram at birth.
- Father, mother or legally acceptable representative properly informed about the study and having signed the informed consent form.
- Parents will commit themselves to comply with the indications of the investigator and with the schedule of the trial.
Exclusion Criteria:
- Infants concomitantly enrolled or scheduled to be enrolled in another trial.
- Infants evolving moderate or severe illness, especially infectious diseases or fever (axillary temperature ≥ 37.5°C on Day 0).
- Infants suspected of uncontrolled coagulopathy or blood disorders contraindicating intramuscular injection, based on anamnesis.
- Infants received or plans to receive any treatment likely to alter the immune response intravenously (immunoglobulins, blood-derived products or long term corticotherapy (> 2 weeks)).
- Infants received other vaccinations with the exception of BCG, poliomyelitis, rotavirus, and PCV.
- Infants with HbsAg and HIV positive (from cord blood)
- Mother suspected of immunodeficiency disease based on anamnesis
学习计划
研究是如何设计的？
设计细节
- 主要用途：预防
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Hep B vaccine in-house
0,5 ml of In-house Recombinant Hepatitis B (Bio Farma) vaccine injected at birth |
0,5 ml In-House Recombinant Hepatitis B (Bio Farma) vaccine injected approximately at birth. The vaccines will be injected intramuscularly into the right anterolateral thigh |
|
有源比较器：Registered Hep B vaccine
0,5 ml of Regstered Hepatitis B (Bio Farma) vaccine injected at birth |
0,5 ml Registered Recombinant Hepatitis B (Bio Farma) vaccine injected approximately at birth. The vaccines will be injected intramuscularly into the right anterolateral thigh |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Protectivity of primary series In-House Recombinant Hepatitis B vaccine
大体时间：28 days after administration of third dose of DTwP-HepB-IPV-Hib (HEXASIIL) vaccine
|
Percentage of subjects with anti HBsAg > 10mIU/ml after the completion of the primary series of recombinant hepatitis B and Registered DTwP-HepB-IPV-Hib (HEXASIIL) vaccine for each group |
28 days after administration of third dose of DTwP-HepB-IPV-Hib (HEXASIIL) vaccine
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Immunogenicity of birth dose In-House Recombinant Hepatitis B vaccine
大体时间：28 days after administration of Hep B birth dose vaccine
|
GMT and percentage of infants with increasing antibody titer ≥ 4 times and/ or percentage of infants with transition of seronegative to seropositive after birth dose Hep B vaccine |
28 days after administration of Hep B birth dose vaccine
|
|
Immunogenicity of In-House recombinant Hepatitis B vaccine after the completion of Registered DTwP-HepB-IPV-Hib (HEXASIIL) vaccine
大体时间：28 days after the third dose of DTwP-HepB-IPV-Hib (HEXASIIL) vaccine
|
GMT and percentage of infants with increasing antibody titer ≥ 4 times and/ or percentage of infants with transition of seronegative to seropositive after completion of Registered DTwP-HepB-IPV-Hib (HEXASIIL) vaccine |
28 days after the third dose of DTwP-HepB-IPV-Hib (HEXASIIL) vaccine
|
|
Safety of In-House Recombinant Hepatitis B vaccine
大体时间：30 minutes, 7 days, 28 days after each dose
|
Percentage of subjects with solicited and unsolicited adverse events after each dose |
30 minutes, 7 days, 28 days after each dose
|
|
Serious Adverse Events
大体时间：28 days after third dose of Registered DTwP-HepB-IPV-Hib (HEXASIIL) vaccine administration
|
Percentage of infants with at least one serious adverse events |
28 days after third dose of Registered DTwP-HepB-IPV-Hib (HEXASIIL) vaccine administration
|
合作者和调查者
赞助
调查人员
- 首席研究员：Rodman Tarigan Girsang, MD、Faculty of Medicine, Padjadjaran University, Bandung
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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