NCT00258843已完成3 期
Clinical Safety Evaluation Study of the Sanofi Pasteur's Inactivated Poliomyelitis Vaccine (IMOVAX Polio™) Administered as a Single Booster Dose at 18 Months of Age in Healthy Chinese Children, and as the First Dose of Primary Vaccination at 2 Months of Age in Healthy Chinese Infants.
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
研究概览
简要总结
To describe the tolerance in terms of occurrence of serious adverse reactions and severe adverse reactions (injection site and systemic) within eight days after one dose of IMOVAX Polio™ administered in children and infants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 18 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Group 1: Aged 18 months (18-20 months) on the day of inclusion
- •Group 2: Aged 2 months (56-70 days) on the day of inclusion
排除标准
- •Participation in another clinical trial in the 4 weeks preceding the trial vaccination
- •Planned participation in another clinical trial during the present trial period
- •Congenital or acquired immunodeficiency, immunosuppressive therapy such as long-term systemic corticosteroids therapy
- •Systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to the trial vaccine or a vaccine containing the same substances
- •Chronic illness at a stage that could interfere with trial conduct or completion
- •Blood or blood-derived products received in the past 3 months (for Group 1) or since birth (for Group 2)
- •Any vaccination in the 4 weeks preceding the trial vaccination (except BCG and Hepatitis B [Hep B] for Group 2)
- •Vaccination planned in the 4 weeks following the trial vaccination
- •Group 1: Previous booster vaccination against the poliomyelitis infection with the trial vaccine or with another vaccine.
- •Group 2: Previous vaccination against the poliomyelitis infection with the trial vaccine or with another vaccine.
- •History of poliomyelitis infection (confirmed either clinically, serologically or microbiologically)
- •Clinical or serological evidence of systemic illness including Hepatitis B, C and HIV
- •Thrombocytopenia or a bleeding disorder contraindicating intramuscular vaccination
- •History of/current seizures
- •Febrile illness (axillary temperature ≥ 37.4°C) or acute illness on the day of inclusion
研究者
研究点 (1)
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