Evaluation of the Response to a Single Dose of Menactra® in Children Aged 5 to 8 Years Who Had Previously Received Two Doses of Quadrivalent (A, C, Y, W-135) Meningococcal Polysaccharide Vaccine Before Age 2 Years in Saudi Arabia
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 238
- 试验地点
- 4
- 主要终点
- Percentage of Participants With ≥ 4-Fold Rise in Titers for the Menactra® Vaccine Serogroups A, C, Y, and W-135.
研究概览
简要总结
This study will be conducted among children in Saudi Arabia who previously received two doses of A, C, Y, W-135 polysaccharide vaccine before the age of 2 years, and in meningococcal vaccine-naïve children (Control Group). This study will evaluate the administration of Menactra® in terms of the serum bactericidal antibody it induces in the two study groups. Safety of Menactra® vaccine will be described.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 5 Years 至 8 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy, as determined by medical history and physical examination.
- •Aged between 5 to 8 years on the day of inclusion (from 5th birthday to 1 day before 9th birthday inclusive).
- •For the Booster Group , two doses of a quadrivalent (A, C, Y, W-135) meningococcal polysaccharide vaccine received before age 2 years
- •For the Control Group , no previous history of any meningococcal vaccination
- •Informed consent form signed by the parent(s) or other legal representative
- •Able to provide a vaccination log or has available vaccination record in the Health Center.
- •Able to attend all scheduled visits and to comply with all trial procedures
排除标准
- •Serious chronic disease (i.e., cardiac, renal, neurologic, metabolic, rheumatologic, psychiatric, etc.)
- •Known or suspected impairment of immunologic function.
- •Acute medical illness with or without fever within the last 72 hours or a oral temperature ≥ 37.5°C at the time of inclusion.
- •Administration of immune globulin or other blood products within the last three months, injected or oral corticosteroids or other immunomodulatory therapy within six weeks of the trial vaccine. Individuals on a tapering dose schedule of oral steroids lasting < 7 days may be included in the trial provided that they have not received more than one course within the last two weeks prior to enrollment.
- •Oral or injected antibiotic therapy within the 72 hours prior to vaccination.
- •Received any vaccine in the 14-day period prior to trial vaccination, or scheduled to receive any vaccination during the 14-day period after trial vaccination.
- •Previous history of documented invasive meningococcal disease.
- •For the Control Group, previous history of any meningococcal vaccination.
- •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.
- •Participation in another clinical trial in the 4 weeks preceding the trial vaccination
- •Planned participation in another clinical trial during the present trial period
- •Any condition, which, in the opinion of the investigator, would pose a health risk to the subject, or interfere with the evaluation of the vaccine.
- •Personal or family history of Guillain Barré syndrome.
研究组 & 干预措施
Group 1: Menactra® Booster Group
Participants who had received 2 doses of quadrivalent (A, C, Y, and W-135) meningococcal polysaccharide vaccine before age 2 years received a booster vaccination with Menactra® vaccine.
干预措施: Menactra®: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate (Biological)
Group 2: Menactra® Primary Vaccine (Control) Group
Participants who had not previously been given any meningococcal vaccine (meningococcal vaccine naive) received a primary vaccination with Menactra® vaccine.
干预措施: Menactra®: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate (Biological)
结局指标
主要结局
Percentage of Participants With ≥ 4-Fold Rise in Titers for the Menactra® Vaccine Serogroups A, C, Y, and W-135.
时间窗: Day 28 Post-vaccination
Geometric Mean Titers (GMTs) as Measured by Serum Bactericidal Assay Using Baby Rabbit Complement (SBA-BR) Pre- and Post-Menactra® Vaccination.
时间窗: Day 0 (baseline or pre-vaccination) and Day 28 Post-vaccination
次要结局
未报告次要终点