NCT04448132已完成4 期
Evaluation of the Persistence of the Immunity in 4-year-old Children Previously Immunised With an Adjuvanted Reduced Dose Inactivated Polio Vaccine, IPV-Al AJV (Picovax®) by Measuring the Response to an Additional Dose of IPV-Al AJV
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 163
- 试验地点
- 1
- 主要终点
- Seroprotection (titer ≥8) against poliovirus types 1, 2 and 3
研究概览
简要总结
The trial is a phase 4, open-label, multicentre clinical trial with healthy subjects who have been vaccinated with IPV-Al AJV at 2, 4, 6 and 15 18 months of age in previous trials. Levels of antibodies against poliovirus types 1, 2 and 3 after immunisation with IPV Al AJV will be measured in the trial subjects at the age of 4 years. An additional IPV-Al AJV dose (investigational vaccine) will be administered and the booster response to IPV-Al AJV will be investigated one month after administration.
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
- 4 Years 至 4 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children that have been vaccinated with IPV-Al AJV in the VIPV-07 and VIPV-07 E1 trials and have completed these trials
- •Healthy, as assessed from medical history and physical examination
- •Parent(s)/guardian(s), according to the local legal requirements, have been properly informed about the trial and have signed the informed consent form
- •Parent(s)/guardian(s), according to the local legal requirements, have been granted access to the child´s trial related medical records
- •Parent(s)/guardian(s), according to the local legal requirements, are likely to comply with trial procedures
排除标准
- •Previous vaccination with OPV
- •Previous vaccination with IPV outside the VIPV-07 and VIPV-07 E1 trials
- •Known or suspected immunodeficiency (e.g. leukaemia, lymphoma) or family history of congenital or hereditary immunodeficiency. HIV is not an exclusion criterion.
- •Severe uncontrolled chronic (e.g. neurologic, pulmonary, gastrointestinal, hepatic, renal or endocrine) disease
- •Known or suspected allergy to vaccine constituents (e.g. hypersensitivity to formaldehyde and/or 2-phenoxy-ethanol)
- •Uncontrolled coagulopathy or blood disorder contraindicating intramuscular injections or blood sampling
- •Treatment with a product which is likely to modify the immune response (e.g. blood products and immunoglobulins) prior to inclusion or planned during the trial period
- •Participating in another interventional clinical trial
- •Not suitable for inclusion in the opinion of the investigator
结局指标
主要结局
Seroprotection (titer ≥8) against poliovirus types 1, 2 and 3
时间窗: One month after administration of an additional dose of IPV-Al AJV
Individual serum titers against poliovirus types 1, 2 and three will be measured in collected serum samples
次要结局
未报告次要终点
研究者
研究点 (1)
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