Antibody Responses to a Booster Dose of an Experimental Tetravalent (A, C, Y, and W-135) Meningococcal Diphtheria Toxoid Conjugate Vaccine, Menactra® in Adolescents Who Previously Received Menomune® or Menactra®
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 241
- 试验地点
- 9
- 主要终点
- Geometric Mean Titers (GMTs) of Serum Bactericidal Activity for Each of the 4 Vaccine Serogroups.
研究概览
简要总结
This study was designed to evaluate the antibody response to a Menactra® booster dose in participants who previously received one dose of Menactra® or Menomune® as adolescents 3 years earlier in Study MTA02.
Primary Objective:
To evaluate the antibody responses to a booster dose of a tetravalent meningococcal diphtheria toxoid conjugate vaccine (Menactra®) in participants who had previously received Menactra® or Menomune® as adolescents in the MTA02 Study and antibody responses to a dose of Menactra® in naive adolescents.
详细描述
All subjects were given a single boosting dose of Menactra® to evaluate the kinetics of the response, the magnitude and the avidity of the antibody produced.
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
- 13 Years 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participant is healthy, as determined by medical history and physical examination.
- •Participant is at least 13 years of age but not yet 22 years of age at time of enrollment.
- •For the Menactra® and Menomune® groups, participant received one dose of Menactra® or Menomune® in MTA02 trial and completed trial (2 blood samples, contacted for Month 6 safety follow up).
- •For the Control group, participant has no previous history of any meningococcal vaccination.
- •If < 18 years of age, participant has signed Institutional Review Board (IRB) approved informed assent form and his/her parent/legal guardian has signed an IRB-approved informed consent form.
- •If ≥ 18 years of age, participant has signed an IRB-approved informed consent form.
- •Able to provide vaccination log.
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 an oral temperature ≥ 100.4ºF (≥ 38.0ºC) at the time of inclusion.
- •For the Menactra® and Menomune® groups, history of documented invasive meningococcal disease or previous meningococcal vaccination with the exception of meningococcal vaccination given as part of MTA02 trial.
- •For the Control group, history of documented invasive meningococcal disease or previous meningococcal vaccination.
- •Administration of immune globulin, other blood products within the last three months, injected or oral corticosteroids or other immunomodulatory therapy within six weeks of the study vaccine. Individuals on a tapering dose schedule of oral steroids lasting < 7 days may be included in the trial as long as they have not received more than one course within the last two weeks prior to enrollment.
- •Antibiotic therapy within the 72 hours prior to vaccination or antibiotic therapy within the 72 hours prior to having any blood sample drawn.
- •Received any vaccine in the 14-day period prior to study vaccination, or scheduled to receive any vaccination during the 14-day period after study vaccination.
- •Suspected or known hypersensitivity to any of the vaccine components.
- •Unavailable for the entire study period or unable to attend the scheduled visits or to comply with the study procedures.
- •In females, a positive or equivocal urine pregnancy test at the time of vaccination.
- •Enrolled in another clinical trial.
- •Any condition, which, in the opinion of the investigator, would pose a health risk to the participant, or interfere with the evaluation of the vaccine.
研究组 & 干预措施
Control Group
Meningococcal vaccine-naïve Control Group.
干预措施: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate (Biological)
Menomune® Group
Received Menomune® vaccine in Study MTA02
干预措施: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate (Biological)
Menactra® Group
Received Menactra® vaccine in Study MTA02
干预措施: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate (Biological)
结局指标
主要结局
Geometric Mean Titers (GMTs) of Serum Bactericidal Activity for Each of the 4 Vaccine Serogroups.
时间窗: Day 0 and 8 and 28 days post-vaccination
Geometric mean titers and their 95% confidence interval of serum bactericidal activity for the 4 vaccine serogroups before vaccination, at 8 days post- and 28 days post-booster dose of Menactra vaccine or a primary dose of Menactra vaccine in the meningococcal vaccine-naïve Control group.
次要结局
未报告次要终点