Immunogenicity and Safety of AVAXIM™ 80U-Pediatric Administered Alone or Concomitantly with TRIMOVAX™ in 12-13 Months old Healthy Hepatitis A Seronegative Turkish Children

Sanofi Pasteur SA0 个研究点目标入组 470 人开始时间: 2015年11月19日最近更新: 2015年12月7日

适应症

试验速览

暂无简介。

•1) Aged 12-13 months on the day of inclusion
•2) Born at full term of pregnancy (>37 weeks) with a birth weight = 2.5 kg
•3) Informed consent form signed by the parent(s) or other legal representative
•4) Able to attend all scheduled visits and to comply with all trial procedures
•5) Subjects having received only one or no injection of vaccine against Measles
•6) Subjects anti-HAV seronegative according to the results obtained at the screening visit*
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 470
•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

•1) Participation in another clinical trial in the 4 weeks preceding the (first) 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 first trial vaccination
•8) Vaccination planned in the 4 weeks following any trial vaccination
•9) History of hepatitis A, Mumps, Measles and/or Rubella infection (confirmed either clinically, serologically or microbiologically)
•10) Previous vaccination against hepatitis A with the trial vaccine or another vaccine
•11) Previous vaccination against Mumps, Measles and Rubella with a Mumps, Measles and Rubella trivalent combined vaccine
•12) Thrombocytopenia or a bleeding disorder contraindicating intramuscular vaccination
•13) History of seizures
•14) Febrile illness (axillary temperature =37.4°C]) on the day of inclusion

发起方

Sanofi Pasteur SA