NCT02093260已完成2 期
Phase II b Study of Immunogenicity and Safety of Flubio Vaccine in Infants and Children
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- PT Bio Farma
- 入组人数
- 405
- 试验地点
- 2
- 主要终点
- To asses the immunogenicity of Flubio vaccine 28 days after 2 doses immunization in infants and children (6 months-8 years of age) and 1 dose immunization in children (9-11 years of age)
研究概览
简要总结
To Asses the Immunogenicity and Safety of Flubio (Influenza HA) Vaccine in Infants and Children (Bridging Study)
详细描述
Too see percentage of subjects with HI titer >= 1:40, 28 days after two doses in infants and children (6 months-8 years old) and one dose in children 9-11 years old for each strain.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 6 Months 至 11 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
- •Subjects concomitantly enrolled or scheduled to be enrolled in another trial
- •Evolving mild, moderate, or severe illness, especially infectious diseases or fever (axillary temperature >=37oC)
- •Known history of allergy to egg and/or chicken protein or any other component of the vaccines
- •Known history of uncontrolled coagulopathy or blood disorders contraindicating intramuscular injection
- •Subject who has received a treatment likely to alter the immune response in the previous 4 weeks (intravenous immunoglobulins, blood-derived products or long term corticotherapy (>2 weeks)).
- •Any abnormality or chronic disease justified by investigator that might interfere assessment of the trial objectives.
- •Subjects has been immunized with influenza vaccine within 1 year
- •Subjects receives any vaccination within 1 months before and after immunization of Flubio.
研究组 & 干预措施
Vaccine
Experimental
Vaccine
Flubio (Influenza HA) vaccine
2 doses for infants and children (6 months - 8 years old)
1 doses for children (9-11 years old)
The vaccine will be given intramuscularly
干预措施: Vaccine (Biological)
结局指标
主要结局
To asses the immunogenicity of Flubio vaccine 28 days after 2 doses immunization in infants and children (6 months-8 years of age) and 1 dose immunization in children (9-11 years of age)
时间窗: 2 months
Percentage of subjects with anti HI titer \>=1:40
次要结局
- To describe the seroconversion after 2 doses of Flubio vaccine in infants and children (6 months-8 years old)(2 months)
- To describe seroconversion after 1 dose of Flubio vaccine in children (9-11 years old)(1 months)
- To asses the safety of Flubio vaccine(1-2 months)
研究者
研究点 (2)
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