Antibody Responses to a Reduced Dose of Menomune® in Children Who Previously Received an Experimental Tetravalent (A, C, Y, and W-135) Meningococcal Diphtheria Toxoid Conjugate Vaccine, TetraMenD
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 173
- 试验地点
- 8
- 主要终点
- Geometric Mean Titers (GMT) of Serum Bactericidal Activity for Each Vaccine Serogroups Before and Post-vaccination.
研究概览
简要总结
This study was designed to simulate meningococcal challenge by vaccination with a fractional combined dose of unconjugated meningococcal polysaccharides A, C, Y, and W-135, Menomune® in children who were vaccinated with one dose of TetraMenD at least 18 months earlier.
Primary Objective:
To evaluate and compare the antibody responses to a reduced dose of Menomune® in participants who had previously received a tetravalent meningococcal diphtheria toxoid conjugate vaccine to those responses in participants who received the same reduced dose of Menomune® but had not previously received any meningococcal vaccine.
详细描述
This was a two stage, controlled, open-label trial. Stage I of the trial simulated meningococcal challenge Stage II of the trial evaluated the meningococcal vaccine naïve participants from Stage I, who had also received a reduced dose of Menomune® vaccine in Stage I and were administered a full dose of Menactra® vaccine 6 months later.
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 5 Years（Child）
- 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 3 years of age but not yet 6 years of age at the enrolment.
- •For the TetraMenD group: received one dose of TetraMenD as a participant in trial 603-02 no less than 18 months prior to enrolment
- •For the Control group: no previous history of any meningococcal vaccination
- •Parent/Guardian has signed Institutional Review Board- (IRB-) approved informed consent form.
- •Participant is healthy, as determined by medical history and physical examination.
- •Participant is at least 3 years of age but not yet 6 years of age at the time of enrollment in Stage
- •Enrolled in the Control group only and received one dose of the reduced dose Menomune at Stage
- •Parent/Guardian has signed Institutional Review Board- (IRB-) approved informed consent form.
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 axillary temperature (≥ 99.5ºF [≥ 37.5ºC]) at the time of inclusion
- •For Stage I, history of documented invasive meningococcal disease or previous meningococcal vaccination with exception of those participants recruited from Trial 603-
- •For Stage II, history of documented invasive meningococcal disease or participant did not receive Reduced-dose Menomune® six months prior.
- •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 28-day period prior to study vaccination, or scheduled to receive any vaccination during the 28-day period after study vaccination in Stage 1 of the trial.
- •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
- •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
Previously received TetraMenD
Participants previously received one dose of a Meningococcal vaccine, TetraMenD in Study 603-02.
干预措施: A/C/Y/W-135, Meningococcal Polysaccharide Vaccine (Menomune®) (Biological)
Meningococcal vaccine-naїve
Participants have never received a Meningococcal vaccine in the past.
干预措施: A/C/Y/W-135, Meningococcal Polysaccharide Vaccine (Menomune®) (Biological)
结局指标
主要结局
Geometric Mean Titers (GMT) of Serum Bactericidal Activity for Each Vaccine Serogroups Before and Post-vaccination.
时间窗: Day 0 and Days 8 and 28 post-vaccination
次要结局
未报告次要终点