Phase IV Safety Monitoring Study of Inactivated Poliomyelitis Vaccine Made From Sabin Strain
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 49,731
- 试验地点
- 1
- 主要终点
- Safety monitoring
研究概览
简要总结
This study includes both active and passive safety monitoring in large pupulations for the phase IV safety monitoring study of Inactivated Poliomyelitis Vaccine Made From Sabin Strain (sIPV).
详细描述
For active safety monitoring in expanding populations, a total of 20,019 participants in Shanghai CDC have been enrolled in accordance with GCP for close safety monitoring for immediate adverse events and telephone or visiting follow-up (30 min, 24h, 3d, 7d, 14d, 30d) For passive safety monitoring in larger populations, the purpose is to observe rare adverse events after primary and booster immunization with sIPV by passive safety surveillance via AEFI monitoring system in Shanghai CDC. A total of 29,712 infants have been enrolled, and the adverse events of the participates have been collected via AEFI monitoring system and evaluated after 3-dose sIPV for primary immunization.
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
- 2 Months 至 3 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy infants of 2 months of age
- •The legal identity certificate (birth/household register) and vaccination certificate of the participants can be provided, and the legal guardian can provide the legal identity certificate (identity card).
- •Guardians are able to understand the experimental vaccine, volunteer to participate in the study and sign informed consent for participation.
- •Guardians are capable of using thermometer, graduated scale, filling diary card and contact card.
- •Participants are not vaccinated with polio vaccine and immunoglobulin (except for Hepatitis b specific immunoglobulin) after birth, no vaccination of live vaccine within 28 days before enrollment and no vaccination of inactivated vaccine within 14 days before enrollment.
- •Participants or guardians are able to obey and follow all study instructions, complete all the monitoring, and cooperate to complete collection of blood sample.
- •Axillary temperature ≤37℃
排除标准
- •Allergic to any active substance, inactive substance or materials used during production such as kanamycin.
- •Patients with fever or acute disease.
- •Have thrombocytopenia or hemorrhagic diseases
- •Patients undergoing immunosuppressive therapy or immunodeficiency
- •Have uncontrolled epilepsy or other progressive neurological disorders
- •Other situations that the investigator consider as non-eligible
结局指标
主要结局
Safety monitoring
时间窗: 30 days post inoculation
Active and passive monitoring for local and systemic adverse reactions
次要结局
未报告次要终点