NCT02095314已完成2 期
Antibody Persistence After Primary Doses, Immune Response and Safety After Doses of Pentabio Vaccine in Indonesian Children at 18-24 Months of Age
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
- 399
- 试验地点
- 6
- 主要终点
- Geomoteric mean titer prior to booster administration of Pentabio vaccine
研究概览
简要总结
Measure antibody persistence prior to booster administration of Pentabio vaccine.
详细描述
Number and percentage of children with anti diphtheria, titer and anti tetanus titer >= 0.01 IU/ml, anti HBs >=10mIU/ml, anti Hib >=0.15ug/ml prior to booster administration.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Months 至 24 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children, 18-24 months of age
- •Subjects who had completed the primary series of Pentabio vaccine in the previous trial
- •Father, mother, or legally acceptable representative have been informed properly regarding the study and signed the informed consent form
- •Subject's parents commit to comply with the instruction
排除标准
- •Subjects concomitantly enrolled or scheduled to be enrolled in another trial
- •Evolving mild, moderate or severe illness, especially infectious diseases or fever (axillary temperature >=37.5oC on Day 0)
- •Known history of uncontrolled coagulopathy or blood disorders contraindicating intramuscular injection
- •Known history of allergy to any component of the vaccines (e.f. formaldehyde)
- •Known history of acquired immunodeficiency (including HIV infection)
- •Subject who has received a treatment likely to alter immune response in the previous 4 weeks (e.g intravenous immunoglobulin, blood-derived products or long term corticotherapy (>2 weeks)
- •Subject receives other vaccination within 1 month prior to inclusion
- •Any abnormality or chronic disease justified by investigator that might interfere assessment of the trial objectives
- •Infant with a known history of diphtheria, tetanus, pertussis, Hepatitis B and Hib infection
结局指标
主要结局
Geomoteric mean titer prior to booster administration of Pentabio vaccine
时间窗: visit 1
The number and percentage of children with anti diphtheria titer and anti tetanus titer \>=0.01 IU/ml anti HBs \>=10 mIU/ml, anti Hib \>=0.15 ug/ml prior to booster administration.
次要结局
- Protectivity of Pentabio vaccine 1 month after the booster dose(1 month)
- Serological response to diphtheria, tetanus, pertussis, hepatitis B and PRP-T before and 1 month after the booster dose(1 month)
- Seroconversion and seroprotection before and 1 month after the booster dose(1 month)
- Number of participants with adverse events(1 month)
研究者
研究点 (6)
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