A Bridging Study to Assess Protectivity and Safety of Quadrivalent Influenza HA Vaccine in Indonesian Population
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- PT Bio Farma
- 入组人数
- 810
- 试验地点
- 3
- 主要终点
- Percentage of subjects with an anti-influenza titer >= 1:40 HI units
研究概览
简要总结
This study is to assess protectivity and safety of Quadrivalent Influenza Vaccine in Indonesian Population
详细描述
To describe the protectivity rate of Quadrivalent Influenza HA vaccine 28 days after immunization in Indonesian population.
To describe immunogenicity of quadrivalent Influenza HA vaccine in all subjects
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, Investigator)
盲法说明
The study for subjects 9-40 years of age is randomized, double blind study. While the study for subjects 6 months-8 years of age is open labeled study.
入排标准
- 年龄范围
- 6 Months 至 40 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
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 C )
- •Known history of allergy to egg and or chicken protein or any component of the vaccines
- •History of uncontrolled coagulopathy or blood disorders contraindicating intramuscular injection
- •Subject who has received in the previous 4 weeks a treatment likely to alter the immune response (intravenous immunoglobulins, blood-derived products or long term corticotherapy (> 2 weeks).
- •Pregnancy & Lactation (Adult)
- •Any abnormality or chronic disease which according to the investigator might interfere with the assessment of the trial objectives
- •Subject already immunized with influenza vaccine within 1 year.
- •Subjects receive any vaccination within 1 month before and after immunization of Quadrivalent Influenza Vaccine.
研究组 & 干预措施
QIV (subjects 6-35 months)
2 dose of 0.25 ml of quadrivalent influenza vaccine
干预措施: Quadrivalent Influenza Vaccine (Biological)
QIV batch 3
1 dose of 0.5 ml of quadrivalent influenza vaccine batch 3
干预措施: Quadrivalent Influenza Vaccine (Biological)
Trivalent Influenza Vaccine
1 dose of 0.5 ml of trivalent influenza vaccine
干预措施: Trivalent Influenza Vaccine (Biological)
QIV batch 1
1 dose of 0.5 ml of quadrivalent influenza vaccine batch 1
干预措施: Quadrivalent Influenza Vaccine (Biological)
QIV batch 2
1 dose of 0.5 ml of quadrivalent influenza vaccine batch 2
干预措施: Quadrivalent Influenza Vaccine (Biological)
QIV (subjects 3-8 years)
2 dose of 0.5 ml of quadrivalent influenza vaccine
干预措施: Quadrivalent Influenza Vaccine (Biological)
结局指标
主要结局
Percentage of subjects with an anti-influenza titer >= 1:40 HI units
时间窗: 28 days after the last dose immunization
The anti-influenza antibody serological response
次要结局
- Percentage of subjects with increasing antibody titer >= 4 times(28 days)
- Percentage of subjects with at least one immediate reaction(30 minutes after each vaccination)
- Geometric Mean Titer (GMT)(28 days)
- Serious adverse event after vaccination(28 days)
- Percentage of subjects with transition of seronegative to seropositive(28 days)
- Comparison adverse events between quadrivalent and trivalent influenza HA vaccine.(28 days)
- Comparison of adverse events between each batch number of quadrivalent influenza HA vaccine.(28 days)
- Percentage of subjects with at least one of these adverse events(within 72 hours, between 72 hours to 28 days after vaccination)