EUCTR2015-005191-18-Outside-EU/EEA进行中（未招募）不适用
Immunogenicity and Safety of Sanofi Pasteur’s AVAXIM 80U Pediatric Vaccine Administered in Healthy Adolescents, Children and Toddlers in People’s Republic of China Followed by a Booster Dose 6 Months after the Initial Dose Versus HAVRIX 720 Vaccine
Sanofi Pasteur SA0 个研究点目标入组 720 人开始时间: 2015年11月19日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 720
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Inclusion criteria to be checked at the screening visit (SC):
- •1) 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
- •2) 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):
- •1) 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
- •2) 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)
- •3) Able to attend all scheduled visits and to comply with all trial procedures
- •4) Subject anti-HAV seronegative (IgG) according to the screening results (assay performed with local kit)
- •5) Subject HBsAg seronegative and ALT <40 IU/l according to the screening results
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 720
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Exclusion criteria to be checked at the inclusion visit (V01):
- •1) Participation in another clinical trial in the 4 weeks preceding trial vaccination
- •2) Planned participation in another clinical trial during the present trial period
- •3) Congenital or acquired immunodeficiency, immunosuppressive therapy such as long-term systemic corticosteroids therapy
- •4) 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
- •5) Chronic illness at a stage that could interfere with trial conduct or completion
- •6) Blood or blood-derived products received in the past 3 months
- •7) Any vaccination in the 4 weeks preceding the trial vaccination
- •8) Any vaccination planned in the 4 weeks following the trial vaccination
- •9) History of hepatitis A infection (confirmed either clinically or serologically )
- •10) Previous vaccination against hepatitis A with the trial vaccine or another hepatitis A vaccine
- •11) Thrombocytopenia or a bleeding disorder contraindicating intramuscular vaccination
- •12) History of /current seizures
- •13) Clinical or serological evidence of systemic illness including Hepatitis C and HIV
- •14) Febrile (axillary temperature = 37.1°C) or acute illness
研究者
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