Phase 3 of Protectivity and Safety of DTP/HB/Hib (Bio Farma) Vaccines in Infants, Batch Consistency, Multi Center Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- PT Bio Farma
- 入组人数
- 600
- 试验地点
- 6
- 主要终点
- Protectivity of DTP/HB/Hib (Bio Farma) vaccine
研究概览
简要总结
The objectives of this study were to analyze the immunogenicity and reactogenicity of DTP/HB/Hib (Bio Farma) combination vaccine.
详细描述
This trial was randomized, double blind, prospective intervention and multi centers. Total 600 subject (6-11 weeks of ages) followed this trial, divided into 3 groups, each group consists of 200 subjects. A number of 342 subjects were recruited in Bandung, while 258 subjects were recruited in Jakarta.
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)
入排标准
- 年龄范围
- 6 Weeks 至 11 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Infant 6-11 week of age
- •Infant born after 37-42 week of pregnancy
- •Infant weighting more than 2.5 kg at birth
- •Father, mother or legally acceptable representative properly informed about the study and having signed the informed consent form
- •Parents commit themselves to comply with the indication of the investigator and with the schedule of the trial
- •Mother at least graduate from elementary school
- •Received Hepatitis B vaccine (Bio Farma) at birth
排除标准
- •Child concomitantly enroll or schedule to be enroll in another trial
- •Evolving moderate or severe illness, especially infectious diseases or fever (axillary temperature >=37.5 Celsius on Day 0)
- •Known history of allergy to any component of the vaccine component (e.g.formaldehyde)
- •History of uncontrolled coagulopathy or blood disorder contraindicating intramuscular injection
- •Known history of congenital or acquired immunodeficiency (including HIV infection)
- •Child who has received in the previous 4 weeks a treatment likely to alter the immune response (intravenous immunoglobulin, blood derived product or long term corticotherapy (>2 weeks)
- •Other vaccination within the 1 month prior to inclusion 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 objective
- •Infant with a known history of diphteria, tetanus, pertussis, Hib, Hepatitis B infection
研究组 & 干预措施
DTP/HB/Hib Vaccine (Batch: A)
Purified diphteria toxoid Purified tetanus toxoid Inactivated Bordetella pertussis HbsAg PRP-TT Aluminum phosphate Natrium Chloride Thimerosal
干预措施: DTP/HB/Hib Vaccine (Biological)
DTP/HB/Hib vaccine (Batch: B)
Purified diphteria toxoid Purified tetanus toxoid Inactivated Bordetella pertussis HbsAg PRP-TT Aluminum phosphate Natrium Chloride Thimerosal
干预措施: DTP/HB/Hib Vaccine (Biological)
DTP/HB/Hib vaccine (Batch: C)
Purified diphteria toxoid Purified tetanus toxoid Inactivated Bordetella pertussis HbsAg PRP-TT Aluminum phosphate Natrium Chloride Thimerosal
干预措施: DTP/HB/Hib Vaccine (Biological)
结局指标
主要结局
Protectivity of DTP/HB/Hib (Bio Farma) vaccine
时间窗: 4 months
Number and percentage of infants with anti diphteria titer and anti tetanus titer \>= 0.01 IU/ml, AntiHBs titer \>=10mlIU/ml, and antiHib titer \>= 0,15ug/ml 28 days after the last injection
次要结局
- Antibody response to Tetanus between groups (three different batch numbers)(4 months)
- Antibody response to Pertussis component between groups (three different batch numbers)(4 months)
- Antibody response to Hepatitis B between groups (three different batch numbers)(4 months)
- Antibody response to Hib/PRP between groups (three different batch numbers)(4 months)
- Incidence rate of adverse event of DTP/HB/Hib (Bio Farma)vaccine between groups(30 minutes, 72 hours, 28 days after immunization)
- Antibody response to diphtheria between groups (three different batch numbers)(4 months)