Comparison of Immunogenicity and Safety of DTP-HB-Hib Using New Hepatitis B Bulk (Bio Farma) With Pentabio® Vaccine Primed With Recombinant Hepatitis B at Birth Dose Using New Hepatitis B Bulk (Bio Farma), in Indonesian Infants
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 发起方
- PT Bio Farma
- 入组人数
- 220
- 试验地点
- 3
- 主要终点
- To evaluate protectivity of DTP-HB-Hib Vaccine (Bio Farma) using new Hepatitis B bulk (Bio Farma)
研究概览
简要总结
This bridging study is a randomized, double-blind, two arms parallel group, prospective intervention study. The primary objective of this study is to evaluate protectivity of DTP-HB-Hib Vaccine (Bio Farma) using new Hepatitis B bulk (Bio Farma).
详细描述
This bridging study is a randomized, double blind, two arms parallel groups, prospective intervention study. Total 220 infants, 0-3 days old will be involved in this study. The subject will be divided into 2 groups, 110 subjects are the investigational group and 110 subjects are the active comparator group.
The objective of this study is to evaluate protectivity of DTP-HB-Hib Vaccine (Bio Farma) using new Hepatitis B bulk (Bio Farma) and to asses the safety of DTP-HB-Hib Vaccine (Bio Farma) and Recombinant Hepatitis B Vaccine using new Hepatitis B bulk (Bio Farma).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
盲法说明
Double (Participant, Investigator) Observer Blind : Investigational Product and Active Comparator are masking Lot number is masking
入排标准
- 年龄范围
- 1 Day 至 3 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy, full term, newborns infants.
- •Infant born after 37-42 weeks of pregnancy.
- •Infant weighing 2500 gram or more 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.
排除标准
- •Child concomitantly enrolled or scheduled to be enrolled in another trial.
- •Child evolving moderate or severe illness, especially infectious diseases or fever (axillary temperature 37.5 celcius degrees on Day 0).
- •Child suspected of allergy to any component of the vaccines (e.g. formaldehyde), based on anamnesis.
- •Child suspected of uncontrolled coagulopathy or blood disorders contraindicating intramuscular injection, based on anamnesis
- •Newborn suspected of congenital or acquired immunodeficiency, based on anamnesis
- •Child received or plans to receive any treatment likely to alter the immune response intravenous (immunoglobulins, blood-derived products or long term corticotherapy (> 2 weeks)).
- •Child received other vaccination with the exception of BCG and poliomyelitis.
- •Child has any abnormality or chronic disease which according to the investigator might interfere with the assessment of the trial objectives.
- •Mother with HbsAg and HIV positive (by rapid test within 30 days prior subject's birth)
- •Mother suspected of immunodeficiency disease based on anamnesis
研究组 & 干预措施
Recombinant Hep B new Bulk + Penta with Recombinant HepB new Bulk
1 dose Recombinant Hepatitis B new Bulk vaccine at birth + 3 doses Pentavalent with Recombinant HepB new Bulk vaccine
干预措施: Recombinant Hepatitis B new Bulk vaccine (Biological)
Recombinant Hep B new Bulk + Penta with Recombinant HepB new Bulk
1 dose Recombinant Hepatitis B new Bulk vaccine at birth + 3 doses Pentavalent with Recombinant HepB new Bulk vaccine
干预措施: DTP-HB-Hib with Recombinant Hepatitis B new Bulk vaccine (Biological)
Hep B (Registered) + Pentabio (Registered)
1 dose Recombinant Hepatitis B vaccine (Registered) + 3 doses Pentabio with Recombinant HepB new Bulk vaccine
干预措施: Recombinant Hepatitis B vaccine (Registered BioFarma) (Biological)
Hep B (Registered) + Pentabio (Registered)
1 dose Recombinant Hepatitis B vaccine (Registered) + 3 doses Pentabio with Recombinant HepB new Bulk vaccine
干预措施: Pentabio (Biological)
结局指标
主要结局
To evaluate protectivity of DTP-HB-Hib Vaccine (Bio Farma) using new Hepatitis B bulk (Bio Farma)
时间窗: 28 days
Percentage of infants with anti-diphtheria titer and anti-tetanus titer more than 0.01 IU/ml, anti HbsAg titer more than 10 mIU/ml, and anti PRP-TT titer more than 0.15 microgram/ml 28 days after the last injection of DTP-HB-Hib using new Hepatitis B bulk (Bio Farma) vaccine group.
次要结局
- To asses the local and systemic reactions within 30 minutes to 7 days after immunization(7 days)
- To asses the local and systemic reactions within 7 days to 28 days after immunization(28 days)
- To asses the local and systemic reactions within 30 minutes(30 minutes)
- To asses the serious adverse event(28 days)