NCT01986322已完成2 期
Phase 2 Study of Immunogenicity and Safety of DPT/HB/Hib (Bio Farma) Vaccine Compared to DTP/HB (Bio Farma) Vaccine Given Simultaneously With Hib (Registered) Vaccine in Indonesian Infants
适应症
试验速览
- 阶段
- 2 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
- Protectivity of DTP/HB/Hib (Bio Farma) vaccine
研究概览
简要总结
The main objective of this study was to evaluate the protectivity and safety of DTP/HB/Hib (Bio Farma) vaccine compared to DTP/HB and Hib vaccine given simultaneously.
详细描述
This trial was randomized, single blind, prospective intervention study. Total 220 subject (6-11 weeks of ages) followed this trial, divided into 2 groups, each group consists of 110 subjects.
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
- Single (Outcomes Assessor)
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 weighing 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 7 days 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
结局指标
主要结局
Protectivity of DTP/HB/Hib (Bio Farma) vaccine
时间窗: 4 months
Percentage of infants with anti diphteria titer and anti tetanus titer \>= 0.01 IU/ml, AntiHbs titer \>=10mlIU/ml, and antiPRP-TT titer \>= 0,15ug/ml 28 days after the last injection (third) in DPT/HB/Hib liquid vaccine group
次要结局
- Antibody response to diphteria toxoid in both group(4 months)
- Incidence rate of adverse event of DTP/Hepatitis B/Hib vaccine (Bio Farma)(30 minutes, 72 hours, 28 days after immunization)
- Antibody response to PRP-T in both group(4 months)
- Antibody response to Tetanus Toxoid in both group(4 months)
- Antibody response to Pertussis component in both group(4 months)
- Antibody response to Hepatitis B in both group(4 months)
研究者
研究点 (3)
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