A Multicenter, Open-label, Interventional Phase 3b Study to Evaluate the Safety, One-year Antibody Persistence, Priming Immune Responses of Three Doses of Eupolio Inj. (Inactivated Polio Vaccine (Sabin Strains)) and Immunogenicity of Two Doses of Eupolio Inj. Following Three Doses of bOPV in Infants
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 2,001
- 试验地点
- 10
- 主要终点
- Immediate reaction
研究概览
简要总结
Eupolio is inactivated poliovirus vaccine (IPV). Major purpose of this study is to evaluate safety of Eupolio in 2,000 infants. In addition to the safety, long-term protection after completion of the three primary vaccinations and extent of protective level after a single boosting dose of Eupolio will be evaluated.
As IPV plus bOPV vaccination schedule (3 doses of bOPV plus 2 doses of IPV in infant-toddle vaccination schedule) has been implemented in some countries, this study will also evaluate Eupolio's safety and protective effect in that schedule.
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
- None
入排标准
- 年龄范围
- 6 Weeks 至 8 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Infants in stable health
- •Male or female 6 to 8 weeks of age
- •Signed informed consent by the infant's parent(s) or legally acceptable representative(s)
排除标准
- •Known or suspected poliomyelitis
- •Known or suspected febrile(symptom of a fever), or chronic illnesses
- •Fever ≥ 38.0℃/100.4℉ within 3 days prior to study registration or intake of drug preventing fever
- •Known or suspected immune disorders (abnormal activity in protective system in human body) or received immunosuppressive therapy (treatment for weaken protective system in human body)
- •Previous use of blood or blood-derived products
- •Previous use of polio vaccines
- •Seizures (temporary abnormalities in muscle tone or movements due to abnormal activity in the brain)
- •Bleeding disorders
- •Household contact or intimate exposure with a confirmed case of polio
- •Any history of allergy (hypersensitivity) to the components of the polio vaccine
- •Participation in another interventional clinical trial simultaneously or within 30 days
研究组 & 干预措施
Safety group
Three doses of Eupolio will be administered at 6, 10 and 14 weeks of age. Only safety will be evaluated for this arm.
干预措施: Eupolio (Biological)
Immunogenicity group 1 (4 Eupolio including 1 boosting dose)
Three doses of Eupolio will be administered at 6, 10 and 14 weeks of age, and additional single dose of Eupolio will be administered one year after the three primary vaccinations.
干预措施: Eupolio (Biological)
Immunogenicity group 2 (3bOPV+2 Eupolio)
bOPV will be administered at 6, 10 and 14 weeks of age, and Eupolio will be administered at 14 and 40 weeks of age.
干预措施: Eupolio (Biological)
结局指标
主要结局
Immediate reaction
时间窗: 30 minutes after each vaccination
Any side effects that occur within 30 minutes after the vaccination
Unsolicited adverse event
时间窗: 28 days after each vaccinations
All unwanted or bad events after vaccination other than solicited adverse event
Solicited adverse event
时间窗: 7 days after each vaccination
Expected local or systemic side effects after vaccination
次要结局
- Priming response(7 days after the boosting vaccination in the 4 Eupolio group)
- Seroprotection rate(4 weeks after the third vaccination, 52 weeks after the third vaccination and 7 days after the boosting vaccination in the 4 Eupolio group/ 4 weeks after the first and second vaccination in the 3bOPV+2Eupolio group)
- Geometric mean titers of neutralizing antibody against polio antigens(4 weeks after the third vaccination, 52 weeks after the third vaccination and 7 days after the boosting vaccination in the 4 Eupolio group / 4 weeks after the first and second vaccination in the 3bOPV+2Eupolio group)
- Seroconversion rate(4 weeks after the third vaccination in the 4 Eupolio group / 4 weeks after the first and second vaccination in the 3bOPV+2Eupolio group)