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临床试验/CTRI/2014/12/005272
CTRI/2014/12/005272已完成3 期

Immunogenicity and Safety of a Meningococcal (Groups A, C, Y and W­135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine (Menactra®) in Subjects Aged 9 to 23 Months in India and in the Russian Federation

Sanofi Pasteur SA0 个研究点目标入组 300 人开始时间: 待定最近更新:
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试验速览

阶段
3 期
状态
已完成
发起方
入组人数
300
研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

入选标准

  • •Male and female subjects aged 9 to 17 months on the day of inclusion.
  • •- Informed consent form has been signed and dated by the parent(s) or other legally acceptable representative(s) (if applicable)
  • •- Subject and parent/legally acceptable representative (if applicable) able to attend all scheduled visits and to comply with all trial procedures.

排除标准

  • •- Participation in the 4 weeks preceding inclusion or planned participation during the present trial period in another clinical trial investigating a vaccine, drug, medical device, or medical procedure.
  • •- Receipt of any vaccine in the 4 weeks preceding each trial vaccination or planned receipt of any vaccine in the 4 weeks following each trial vaccination, except for
  • •- Influenza vaccination, which may be received at least 2 weeks before study vaccines.
  • •- measles (M) or measles, mumps, rubella (MMR) routine vaccination, which can be administered concomitantly with the first dose of study vaccine as per routine immunization schedule
  • •- Previous vaccination against meningococcal disease with either the study vaccine or another meningococcal vaccine
  • •- Receipt of immune globulins, blood or blood-derived products in the past 3 months
  • •- Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months)
  • •- History of meningococcal diseases, confirmed either clinically, serologically, or microbiologically
  • •- At high risk, in the opinion of the Investigator, for meningococcal disease during the trial
  • •- Known or suspected systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccine used in the trial or to a vaccine containing any of the same substances
  • •- Known thrombocytopenia, contraindicating intramuscular vaccination
  • •- Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular vaccination
  • •- In an emergency setting, or hospitalized involuntarily
  • •- Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with trial conduct or completion
  • •- Moderate or severe acute illness/infection (according to investigator judgment) on the day of vaccination or febrile illness (temperature >= 38.0°C).
  • •- Receipt of oral or injectable antibiotic therapy within 72 hours prior to the first blood draw
  • •- Identified as a natural or adopted child of the Investigator or employee with direct involvement in the proposed study
  • •- Personal history of Guillain-Barré Syndrome.

研究者

发起方
Sanofi Pasteur SA

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