NCT00313950已完成4 期
Immunogenicity and Safety of AVAXIM™ 80U-Pediatric Administered Alone or Concomitantly With TRIMOVAX™ in 12-13 Months Old Healthy Hepatitis A Seronegative Turkish Children
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 470
- 试验地点
- 1
- 主要终点
- To provide information concerning the immunogenicity of Hepatitis A Vaccine in subjects receiving Pediatric vaccines.
研究概览
简要总结
The present study will explore the immunogenicity of AVAXIM™ 80U-Pediatric in 12-13 months Turkish children and check if the administration of the MMR trivalent vaccine on the same day but at different site will interfere on immunogenicity for the four valences Hepatitis A, Measles, Mumps, and Rubella.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 12 Months 至 13 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged 12-13 months on the day of inclusion
- •Born at full term of pregnancy (>37 weeks) with a birth weight ≥ 2.5 kg
- •Informed consent form signed by the parent(s) or other legal representative
- •Able to attend all scheduled visits and to comply with all trial procedures
- •Subjects having received only one or no injection of vaccine against Measles
- •Subjects anti-HAV seronegative according to the results obtained at the screening visit*
排除标准
- •Participation in another clinical trial in the 4 weeks preceding the (first) 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 first trial vaccination
- •Vaccination planned in the 4 weeks following any trial vaccination
- •History of hepatitis A, Mumps, Measles and/or Rubella infection (confirmed either clinically, serologically or microbiologically)
- •Previous vaccination against hepatitis A with the trial vaccine or another vaccine
- •Previous vaccination against Mumps, Measles and Rubella with a Mumps, Measles and Rubella trivalent combined vaccine
- •Thrombocytopenia or a bleeding disorder contraindicating intramuscular vaccination
- •History of seizures
- •Febrile illness (axillary temperature ≥37.4°C]) on the day of inclusion
结局指标
主要结局
To provide information concerning the immunogenicity of Hepatitis A Vaccine in subjects receiving Pediatric vaccines.
时间窗: Day 7 - Day 196
次要结局
未报告次要终点
研究者
研究点 (1)
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