Comparison of Immunogenicity and Safety of DTP-HB-Hib (Bio Farma) With Pentabio® Vaccine Primed With Recombinant Hepatitis B at Birth Dose (Using Different Source of Hepatitis B), in Indonesian Infants
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 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) with new Hepatitis B bulk
研究概览
简要总结
Comparison of Immunogenicity and Safety of DTP-HB-Hib (Bio Farma) with Pentabio® vaccine Primed with Recombinant Hepatitis B
详细描述
Comparison of Immunogenicity and Safety of DTP-HB-Hib (Bio Farma) with Pentabio® vaccine Primed with Recombinant Hepatitis B at Birth dose (using different source of Hepatitis B), in Indonesian Infants
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
Randomized, double blind, 2 arms parallel group, prospective intervention study This study will do the lot to lot consistency and will be compared to registered product
入排标准
- 年龄范围
- 0 Days 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.
- •Mother with HBsAg positive.
- •Evolving mild, moderate or severe illness, especially infectious diseases or fever (axillary temperature >37.5C on Day 0).
- •Suspected of allergy to any component of the vaccines (e.g. formaldehyde).
- •Suspected of uncontrolled coagulopathy or blood disorders contraindicating intramuscular injection.
- •Newborn suspected of congenital or acquired immunodeficiency (including HIV infection).
- •Received or plans to receive any treatment likely to alter the immune response (intravenous immunoglobulins, blood-derived products or long term corticotherapy (> 2 weeks)).
- •Received other vaccination with the exception of BCG and poliomyelitis.
- •Any abnormality or chronic disease which according to the investigator might interfere with the assessment of the trial objectives.
结局指标
主要结局
To evaluate protectivity of DTP-HB-Hib Vaccine (Bio Farma) with new Hepatitis B bulk
时间窗: 28 days after immunization
Percentage of infants with anti-diphtheria titer and anti-tetanus titer \> 0.01 IU/ml, anti HbsAg titer \> 10 mIU/ml, and anti PRP-T titer \> 0.15 ug/ml 28 days after the last injection of DTP/HB/Hib with different source of Hepatitis B bulk vaccine group.
次要结局
- Geometric mean of anti-HbsAg(28 days after immunization)
- Serological response to Hib/PRP(28 days after immunization)
- Describes antibody response to diphtheria toxoid, tetanus toxoid in both group with the evaluation criteria(28 days after immunization)
- Serological response to the pertussis component (agglutinins)(28 days after immunization)
- Seroconversion(28 days after immunization)