NCT02093273已完成2 期
Phase II, Randomized, Double Blind, Prospective Intervention Study to Evaluate the Immunogenicity and Safety Profile of tOPV (Bio Farma) With Different Batch Numbers 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
- 240
- 试验地点
- 4
- 主要终点
- To compare the antibody response 30 days after two doses of tOPV
研究概览
简要总结
The objective of this study is to compare the antibody response 30 days after two doses of t OPV
详细描述
The trial design is phase II, randomized, double blind, prospective intervention study. The subject study are 240 healthy, full term, newborn 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, Outcomes Assessor)
入排标准
- 年龄范围
- 1 Minute 至 1 Day（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy, full term, newborns infants
- •newborn residing within a relatively short and easily accessible distance A(<30km) from the study clinic(s) and not planning to travel away during the entire study period
- •Infant born after 37 weeks of pregnancy
- •Infant weighing 2.5kg or more at birth (birth weight >= 2.5kg)
- •Healthy newborns, with no history of asphyxia or meconium aspiration
- •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
- •Mother at least elementary school graduate
排除标准
- •Child concomitantly enrolled or scheduled to be enrolled in another trial
- •Known history of congenital or acquired immunodeficiency (including HIV infection)
- •Evolving moderate or severe illness, especially infectious diseases or fever (axillary temperature >=37.5oC
- •Newborns requiring hospitalization at birth
- •Infant immunized with non-scheduled OPV or IPV during trial
结局指标
主要结局
To compare the antibody response 30 days after two doses of tOPV
时间窗: 30 days
antibody titer to Polio
次要结局
- To asses and compare the safety of tOPV(30 days)
研究者
研究点 (4)
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