NCT07297186已完成3 期
A Randomized, Blinded, Parallel Positive-controlled Clinical Trial of Sabin Strain Inactivated Poliovirus Vaccine (Vero Cell) Conducted in Healthy Infants Aged Two Months.
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,200
- 试验地点
- 1
- 主要终点
- the seroconversion rates of poliovirus type I, type II and type III neutralizing antibodies
研究概览
简要总结
The study aimed to evaluate the safety and immunogenicity of a Sabin strain-based inactivated polio vaccine in infants aged two months (60~89 days).
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)
入排标准
- 年龄范围
- 60 Days 至 89 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy permanent residents aged 2 months (60~89 days);
- •Infant's legal guardians agree to sign the informed consent forms voluntarily;
- •Infant's legal guardians are able to comply with the requirements of the clinical trial protocol;
- •Armpit temperature ≤ 37.0 ℃
排除标准
- •preterm birth (gestational age < 37 weeks);
- •the presence of congenital malformations, developmental disorders, genetic defects, or severe malnutrition;
- •had a history of poliomyelitis;
- •had a personal or family history of allergy, convulsions, epilepsy, encephalopathy, or psychiatric disorders;
- •had known hypersensitivity to any component of the study vaccine or a history of severe allergic reaction (e.g., anaphylaxis) to any previous vaccination;
- •had immunodeficiency or receipt of immunosuppressive therapy;
- •diagnosed coagulation disorders (including factor deficiencies, coagulopathies, platelet abnormalities) or evidence of significant bruising/bleeding diathesis;
- •had known or investigator-suspected concurrent acute or active chronic diseases (including respiratory, cardiovascular, hepatic, renal, or dermatological conditions) or acute infection, or maternal HIV infection;
- •occurrence of fever (axillary temperature ≥ 38.0 °C) within the 3 days preceding enrollment;
- •had acute illness requiring systemic antibiotic or antiviral treatment within the 7 days preceding enrollment;
- •administration of blood products within the 3 months preceding enrollment;
- •had receipt of any live attenuated vaccine within the 14 days preceding enrollment;
- •had receipt of any inactivated or subunit vaccine within the 7 days preceding enrollment;
- •had recent administration of any other experimental product and any other condition deemed by the investigator as potentially interfering with the assessment of trial outcomes.
研究组 & 干预措施
control group
Active Comparator
600 participants
干预措施: wIPV (Biological)
study group
Experimental
600 participants
干预措施: sIPV (Biological)
结局指标
主要结局
the seroconversion rates of poliovirus type I, type II and type III neutralizing antibodies
时间窗: 30 days after the primary immunization
次要结局
未报告次要终点
研究者
研究点 (1)
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