NCT04183114已完成2 期
Immunogenicity & Safety of Bio Farma's Measles-Rubella (MR) Vaccine in Indonesian Infants (Bridging Study)
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
- 540
- 试验地点
- 2
- 主要终点
- Protectivity of Measles
研究概览
简要总结
Thus study is a clinical trial for Measles and Rubella vaccine that will be used inIndonesian National Program of Immunization. The study design will be randomized, observer blind, prospective intervention study.
详细描述
The objectives of the study are:
- To assess the protectivity rate of Bio Farma's Measles/Rubella (MR) vaccine in infants
- To describe antibody response to Measles and Rubella after 1 dose of Bio Farma's MR vaccine as a primary dose in infants
- To assess the safety of Bio Farma's Measles/Rubella (MR) vaccine in infants
- To evaluate immunogenicity and safety one dose of Bio Farma's MR vaccine compare to registered MR vaccine.
- To evaluate immunogenicity and safety in three consecutive batches of Bio Farma's MR vaccine in 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
- Triple (Care Provider, Investigator, Outcomes Assessor)
盲法说明
The masking uses observer blind with some unmasked staff to prepare the vaccine to be administered by masked investigator.
入排标准
- 年龄范围
- 9 Months 至 12 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy Infants, 9-12 months
- •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
- •Subject concomitantly enrolled or scheduled to be enrolled in another trial.
- •Evolving mild, moderate or severe illness, especially infectious diseases or fever (axillary temperature > 37.5 Centigrade).
- •Known history of allergy to neomycin, kanamycin or erythromycin or any component of the vaccines.
- •History of immunodeficiency disorder or disorders like HIV infection, leukemia, lymphoma, or generalized malignancy that can alter immune response.
- •Subjects who have previously received any measles and/or rubella containing vaccines.
- •Subjects who had a clinical history of measles/rubella infection.
- •Subjects who has received in the previous 3 months a treatment likely to alter the immune response (intravenous immunoglobulin, blood-derived products or long term corticosteroidtherapy (> 2 weeks).
- •Any abnormality or chronic disease which according to the investigator might interfere with the assessment of the trial objectives.
- •Subject already immunized with any vaccine within 4 weeks prior vaccination.
结局指标
主要结局
Protectivity of Measles
时间窗: 4 months
Percentage of subjects with anti measles titer ≥ 8(1/dil), 28 days after one dose of Bio Farma's MR vaccine in Infants
Protectivity of Rubella
时间窗: 4 months
Percentage of subjects with anti rubella titer ≥11 IU/ml, 28 days after one dose of Bio Farma's MR vaccine in Infants
次要结局
- Safety (14 days)(up to 14 days after vaccination)
- Safety comparison between MR vaccine and control(up to 1 months/28 days)
- Safety (immediate reactions)(up to 30 minutes after vaccination)
- Safety (72 hours)(up to 72 hours after vaccination)
- Safety (15 days to 28 days)(up to 14 days)
- Safety (Serious adverse event)(up to 1 months/28 days)
- Safety comparison between each batch of MR vaccine(up to 1 months/28 days)
- Comparison between each batch number of Bio Farma's MR vaccine.(up to 4 months)
- Immunogenicity of MR Vaccine in infants GMT(up to 4 months)
- Immunogenicity of MR Vaccine (4 Folds increase of antibody titer)(up to 4 months)
- Immunogenicity of MR Vaccine (seroconversion)(up to 4 months)
- Comparison Between MR (Bio Farma) Vaccine and Registered MR Vaccine(up to 4 months)
研究者
研究点 (2)
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