LBCTR2020073458Other3 期
A Phase III, open-label, study to describe the immunogenicity and safety of MenACYW conjugate vaccine in potential pilgrims = 56 years of age in Turkey and Lebanon. - MEQ00063
适应症
试验速览
- 阶段
- 3 期
- 状态
- Other
- 入组人数
- 150
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Single Arm Study
- 主要目的
- Prevention
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 56 至 90（—）
- 性别
- All
入选标准
- •An individual must fulfill all of the following criteria in order to be eligible for trial enrollment:
- •1)Aged = 56 years on the day of inclusion
- •2)Informed consent form has been signed and dated
- •3)Able to attend all scheduled visits and to comply with all trial procedures
- •4)Intending to go on a Hajj or Umrah pilgrimage (but not within the next 10 to 12 months after vaccination)
排除标准
- •An individual fulfilling any of the following criteria is to be excluded from trial enrollment:
- •1)Subject is pregnant, or lactating, or of childbearing potential
- •2)Participation in another clinical trial
- •3)Receipt of any vaccine in the 4 weeks (28 days) preceding the trial vaccination or planned receipt of any vaccine prior to Visit 2 except for influenza vaccination
- •4)Any previous vaccination against meningococcal disease with either the trial vaccine or another vaccine
- •5)Receipt of immune globulins, blood or blood-derived products in the past 3 months
- •6)Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy
- •7)History of meningococcal infection
- •8)At high risk for meningococcal infection during the trial
- •9)Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccines
- •10)Personal history of Guillain-Barre syndrome (GBS)
- •11)Personal history of an Arthus-like reaction after vaccination with a tetanus toxoid-containing vaccine
- •12)Verbal report thrombocytopenia
- •13)Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion
- •14)Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily
- •15)Current alcohol abuse or drug addiction
- •16)Chronic illness that, in the opinion of the Investigator, is at a stage where it might interfere with trial conduct or completion
- •17)Moderate or severe acute illness/infection on the day of vaccination or febrile illness (temperature = 38.0°C).
- •18)Receipt of oral or injectable antibiotic therapy within 72 hours prior to the first blood draw
- •19)Identified as an Investigator or employee of the Investigator or study center with direct involvement in the proposed study, or identified as an immediate family member of the Investigator or employee with direct involvement in the proposed study
- •(Protocol page 14, 15)
研究者
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