Immunogenicity and Safety Profile of Primary Dose of Bivalent OPV (bOPV Bio Farma) Given Simultaneously With Pentabio® And Inactivated Poliovirus Vaccine (IPV) at the 4th Visit in Indonesian Infants
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- PT Bio Farma
- 入组人数
- 143
- 试验地点
- 2
- 主要终点
- Number of subjects with anti polio titer ≥ 8 for type 1, 2 and type 3
研究概览
简要总结
This study is to assess protectivity following four doses of bOPV which given simultaneously with Pentabio® and 1 dose of IPV at the 4th visit
详细描述
To describe serological response after four doses of bOPV with 1 dose of IPV. To describe the antibody status to polio 60 days after birth dose of bOPV To assess the safety of bOPV which given simultaneously with Pentabio® and 1 dose 1 dosde of IPV at the 4th visit
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
- 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.
- •Newborns residing within a relatively short and easily accessible distance (<30 km) 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 2.5 kg or more at birth (Birth weight > 2.5 kg)
- •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 ≥ 37.5°C )
- •Newborns requiring hospitalization at birth.
- •Infant immunized with non-scheduled bOPV or IPV during trial
研究组 & 干预措施
bOPV (bivalent OPV Bio Farma)
bOPV one dose corresponds to 2 drops (0.1ml). The vaccine shall be given orally.
The subject received bOPV, Pentabio and IPV according to the study schedule.
干预措施: IPV (Biological)
bOPV (bivalent OPV Bio Farma)
bOPV one dose corresponds to 2 drops (0.1ml). The vaccine shall be given orally.
The subject received bOPV, Pentabio and IPV according to the study schedule.
干预措施: bOPV (Biological)
bOPV (bivalent OPV Bio Farma)
bOPV one dose corresponds to 2 drops (0.1ml). The vaccine shall be given orally.
The subject received bOPV, Pentabio and IPV according to the study schedule.
干预措施: Pentabio (Biological)
结局指标
主要结局
Number of subjects with anti polio titer ≥ 8 for type 1, 2 and type 3
时间窗: 30 days after the last vaccination
Evaluate protectivity
次要结局
- Percentage of infants with transition of seronegative to seropositive(30 days after the last vaccination)
- Geometric Mean Titer (GMT) after four doses of bOPV with 1 dose of IPV(30 days after the last vaccination)
- Number and severity of systemic adverse events (AEs) after each dose of bOPV, which given simultaneously with Pentabio and 1 dose of IPV(first 30 minutes, 24hour, 48hour, 72hour and 30 days after vaccination.)
- Number of serious adverse events (SAE) which occured during the study(30 days after the last vaccination)
- Percentage of infants with increasing antibody titer >= 4 times(30 days after the last vaccination)