NCT00700635已完成2 期
Exploratory Evaluation of a Two-dose Schedule Versus a One-dose Schedule of Menactra® (Meningococcal [Groups A, C, Y and W 135] Polysaccharide Diphtheria Toxoid Conjugate Vaccine) in Children in the US
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 333
- 试验地点
- 15
- 主要终点
- Percentage of Participants With Meningococcal Antibody Titers ≥ 8 After Each Vaccination
研究概览
简要总结
To explore the potential benefit of the administration of Menactra vaccine as a two-dose regimen to children.
Primary Objective:
To assess, by age group, the immune response to Menactra vaccine after each vaccine injection.
详细描述
This is an open-label trial designed to explore the immune response to a two-dose schedule of Menactra vaccine compared with a standard one-dose schedule in children.
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
- 2 Years 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged 2 to < 11 years on the day of inclusion.
- •Provision of assent form signed by the subject (depending on age) and informed consent form signed by the parent(s) or another legally acceptable representative.
- •Subject and parent/legal guardian able to attend all scheduled visits and comply with all trial procedures.
排除标准
- •Previous vaccination against meningococcal disease with either the trial vaccine or another vaccine.
- •Participation in the active (i.e., treatment) portion of another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding the first trial vaccination.
- •Planned participation in another clinical trial during the present trial period.
- •Known or suspected congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term systemic corticosteroids therapy.
- •Suspected or known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to a product containing any of the substances present in the study vaccine .
- •Chronic illness at a stage that could interfere with trial conduct or completion, in the opinion of the Investigator.
- •Receipt of blood or blood-derived products in the past 3 months.
- •Received any vaccine (other than desensitization therapy for allergies or influenza vaccine within 2 weeks before vaccination) in the 4 weeks preceding the first trial vaccination.
- •Planned receipt of any vaccine within the 4 weeks following any trial vaccination(s).
- •Known human immunodeficiency virus (HIV), hepatitis B surface antigen (HBs antigen), or hepatitis C seropositivity.
- •History of invasive meningococcal infection (confirmed either clinically, serologically, or microbiologically).
- •Thrombocytopenia, coagulation disorder, or anticoagulant use in the 3 weeks preceding inclusion contraindicating intramuscular (IM) vaccination.
- •Anticipated to receive oral or injected antibiotic therapy within the 72 hours prior to any of the trial blood draws.
- •Personal or family history of Guillain-Barré Syndrome (GBS).
- •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.
研究组 & 干预措施
Menactra® Group 1
Experimental
Participants aged 2 to < 4 years
干预措施: Menactra®: Meningococcal Polysaccharide Diphtheria Conjugate (Biological)
Menactra® Group 2
Experimental
Participants aged 4 to < 6 years
干预措施: Menactra®: Meningococcal Polysaccharide Diphtheria Conjugate (Biological)
Menactra® Group 3
Active Comparator
Participants aged 6 to < 11 years
干预措施: Menactra®: Meningococcal Polysaccharide Diphtheria Conjugate (Biological)
结局指标
主要结局
Percentage of Participants With Meningococcal Antibody Titers ≥ 8 After Each Vaccination
时间窗: 30 days post-vaccination
Meningococcal serogroups A, C, Y, and W-135 antibody titers were measured by serum bactericidal assay using human complement (SBA-HC)
次要结局
- Percentage of Participants With Meningococcal Antibody Titers at ≥ 4 After Each Vaccination(30 days post-vaccination)
- Geometric Mean Titers (GMTs) of Meningococcal Antibodies After Each Menactra® Vaccination.(30 days post-vaccination)
- Percentage of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions After Dose 2 Vaccination(7 days post-vaccination 2)
- Percentage of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions After Dose 1 Vaccination(7 days post-vaccination 1)
研究者
研究点 (15)
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