NCT00483470已完成3 期
Immunogenicity and Safety of Sanofi Pasteur's AVAXIM 80U Pediatric Vaccine Followed by Booster Dose
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 720
- 试验地点
- 3
- 主要终点
- To provide information concerning the immunogenicity of AVAXIM 80U Pediatric vaccine
研究概览
简要总结
As per request by the Heath Authorities, the present clinical study will assess the immunogenicity and safety
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
- 12 Months 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Inclusion criteria to be checked at the screening visit (SC):
- •Toddlers, children and adolescents:
- •Sub-Group 1: from 12 months to 3 years of age on the day of inclusion
- •Sub-Group 2: from 4 to 6 years of age on the day of inclusion
- •Sub-Group 3: from 7 to 9 years of age on the day of inclusion
- •Sub-Group 4: from 10 to 12 years of age on the day of inclusion
- •Sub-Group 5: from 13 to 15 years of age on the day of inclusion
- •Screening informed consent form signed by the parent(s) or other legal representative for all the subjects and by the adolescents (sub-group 5 only)
- •Inclusion criteria to be checked at the inclusion visit (V01):
- •Toddlers, children and adolescents:
- •Sub-Group 1: from 12 months to 3 years of age on the day of inclusion
- •Sub-Group 2: from 4 to 6 years of age on the day of inclusion
- •Sub-Group 3: from 7 to 9 years of age on the day of inclusion
- •Sub-Group 4: from 10 to 12 years of age on the day of inclusion
- •Sub-Group 5: from 13 to 15 years of age on the day of inclusion
- •Inclusion informed consent form signed by the parent(s) or other legal representative for all the subjects and by the adolescents (sub-group 5 only)
- •Able to attend all scheduled visits and to comply with all trial procedures
- •Subject anti-HAV seronegative (IgG) according to the screening results (assay performed with local kit)
- •Subject HBsAg seronegative and ALT <40 IU/l according to the screening results
排除标准
- •Exclusion criteria to be checked at the inclusion visit (V01):
- •Participation in another clinical trial in the 4 weeks preceding 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 vaccines components or history of a life-threatening reaction to the trial vaccines 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
- •Any vaccination in the 4 weeks preceding the trial vaccination
- •Any vaccination planned in the 4 weeks following the trial vaccination
- •History of hepatitis A infection (confirmed either clinically or serologically )
- •Previous vaccination against hepatitis A with the trial vaccine or another hepatitis A vaccine
- •Thrombocytopenia or a bleeding disorder contraindicating intramuscular vaccination
- •History of /current seizures
- •Clinical or serological evidence of systemic illness including Hepatitis C and HIV
- •Febrile (axillary temperature ≥ 37.1°C) or acute illness
研究组 & 干预措施
1
Experimental
干预措施: Hepatitis A vaccine AVAXIM 80U (Biological)
2
Active Comparator
干预措施: Hepatitis A vaccine (HAVRIX 720) (Biological)
结局指标
主要结局
To provide information concerning the immunogenicity of AVAXIM 80U Pediatric vaccine
时间窗: 1 month post-vaccination
次要结局
未报告次要终点
研究者
研究点 (3)
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