Antibody Persistence and Booster Dose Response in Subjects Who Received Menactra® (Meningococcal [Groups A, C, Y, and W-135] Polysaccharide Diphtheria Toxoid Conjugate Vaccine) Three Years Earlier in Study MTA26
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 181
- 试验地点
- 13
- 主要终点
- Percentage of Participants With Serum Meningococcal Serogroups A, C, Y, and W-135 Bactericidal Antibody Titers ≥ 1:4 and ≥ 1:8 Before and Following Vaccination With Menactra®
研究概览
简要总结
Study will evaluate the persistence of antibodies approximately three years after an initial dose of Menactra® vaccine in toddlers who participated in study MTA26 (NCT00643916) and age-matched Menactra naive participants.
Objectives:
- To assess the persistence of antibody responses three years after one or two doses of Menactra® vaccine in subjects who participated in study MTA26.
- To describe the antibody responses to a single dose of Menactra® vaccine in subjects who had previously received one or two doses of Menactra® vaccine and in Menactra® vaccine-naïve subjects.
- To describe the safety profile of a single dose of Menactra® vaccine in subjects.
详细描述
Subjects that received Menactra® vaccine in study MTA26 (NCT00643916) and age-matched Menactra naive participants will receive a single dose of Menactra® on Day 0. They will be evaluated for immunogenicity and safety post-vaccination.
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
- 3 Years 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects received one or two doses of Menactra® vaccine in study MTA26 and provided a blood sample after the last dose received
- •At 3 to < 6 years of age and were never vaccinated against meningococcal disease (with either the study vaccine or another vaccine).
- •Informed consent form signed and dated by the parent(s) or another legally acceptable representative.
- •Subject and parent/legal guardian able to attend all scheduled visits and comply with all study procedures.
排除标准
- •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 study 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.
- •Known or suspected systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the study vaccine or 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.
- •Received 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 study vaccination.
- •Planned receipt of any vaccine within the 4 weeks following the study vaccination.
- •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 vaccine-naïve Group
Participants had never received Menactra® vaccine.
干预措施: Meningococcal polysaccharide diphtheria toxoid conjugate (Biological)
Two-Dose Menactra Group
Participants received two doses of Menactra® in Study MTA26
干预措施: Meningococcal polysaccharide diphtheria toxoid conjugate (Biological)
One-Dose Menactra Group
Participants received one dose of Menactra® in Study MTA26
干预措施: Meningococcal polysaccharide diphtheria toxoid conjugate (Biological)
结局指标
主要结局
Percentage of Participants With Serum Meningococcal Serogroups A, C, Y, and W-135 Bactericidal Antibody Titers ≥ 1:4 and ≥ 1:8 Before and Following Vaccination With Menactra®
时间窗: Day 0 (pre-vaccination) and Day 30 post-vaccination
Antibody titers to meningococcal serogroups A, C, Y, and W-135 were measured by serum bactericidal assay using human complement (SBA-HC). Bactericidal antibody persistence to meningococcal serogroups was defined as as pre-vaccination titers of ≥1:4 and ≥1:8. Booster response to a single Menactra vaccine dose was defined as antibody titers of ≥1:4 and ≥1:8 30 days post-booster vaccination.
次要结局
未报告次要终点