Reactogenicity and Protectivity Following Measles- Rubella (MR) Routine Immunization in Indonesian Infants and Children
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- PT Bio Farma
- 入组人数
- 590
- 试验地点
- 1
- 主要终点
- Number of Immediate systemic events
研究概览
简要总结
to assess safety and immunogenicity of measles-rubella (MR) routine immunization in Indonesian Children and Infants
详细描述
- to asses serious immediate systemic events,
- to assess local and systemic reaction after Measles-Rubella (MR) vaccine in infants and children,
- to evaluate protectivity and antibody response to measles and rubella after 1 dose of MR vaccine
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)
盲法说明
laboratory analyst are masked for the evaluation of antibody against measles and rubella. The immunogenicity is measured before and after vaccination.
入排标准
- 年龄范围
- 9 Months 至 47 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy infants (9-12 months) or children (18-47 months)
- •Will receive MR routine immunization.
- •Parents have been informed properly regarding the study and signed the informed consent form.
- •Parents will commit themselves to comply with the instructions of the investigator and the schedule of the trial.
排除标准
- •MR vaccine given simultaneously with other vaccination, except Pentabio (DTP/HB/Hib)
研究组 & 干预措施
Sub Study (Measles-Rubella vaccine)
open labeled, prospective intervention study, assess the safety and immunogenicity outcome. The Measles-Rubella vaccine is administered in infants age 9-12 months or 18 - 47 months. For Sub study, pre- and post immunization sera will be obtained from 200 infants and/or children. Safety assessment also evaluated for 28 days after immunization.
干预措施: Measles-Rubella (MR) Vaccine (Biological)
Safety Study (Measles-Rubella vaccine)
open labeled, prospective intervention study, only assess the safety outcome. The Measles-Rubella vaccine is administered in infants age 9-12 months or 18 - 47 months. This study group only assessed for safety profile of the Measles-Rubella vaccine.
干预措施: Measles-Rubella (MR) Vaccine (Biological)
结局指标
主要结局
Number of Immediate systemic events
时间窗: 30 minutes
Number of subjects with at least one serious immediate systemic events within 30 minutes after vaccination
Percentage of immediate systemic events
时间窗: 30 minutes
Percentage of subjects with at least one serious immediate systemic events within 30 minutes after vaccination
次要结局
- Late Safety (Systemic event)(14 days)
- Immunogenicity for Measles (seroconversion from seronegative to seropositive)(28 days)
- Immunogenicity for Rubella (increasing rubella antibody titer ≥ 4 times)(28 days)
- Immunogenicity for Rubella (seroconversion from seronegative to seropositive)(28 days)
- Systemic reaction(72 hours)
- Delayed Local reaction(11 days)
- Immunogenicity for Measles (Geometric Mean Titer)(28 days)
- Immunogenicity for Measles (increasing measles antibody titer ≥ 4 times)(28 days)
- Safety (serious adverse event)(28 days)
- Immunogenicity for Rubella (Subjects with anti rubella titer ≥11 IU/ml)(28 days)
- Delayed systemic event(11 days)
- Late Local reaction(14 days)
- Immunogenicity for Measles (subject with anti measles titer ≥ 8 (1/dil))(28 days)
- Local reaction(72 hours)
- Immunogenicity for Rubella (Geometric Mean Titer)(28 days)