Antibody Responses for Serogroup C After One Dose of an Experimental Tetravalent (A, C, Y, and W-135) Meningococcal Diphtheria Toxoid Conjugate Vaccine Versus a Non-meningococcal Control Vaccine in Children Who Have Previously Received a Monovalent Meningococcal C Conjugate Vaccine
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 103
- 试验地点
- 2
- 主要终点
- Geometric Mean of Antibody Titers (GMTs) as Measured by Serum Bactericidal Assay (SBA) at Baseline (Day 0) and Day 28 Post-vaccination.
研究概览
简要总结
The study investigated safety profile and the antibody responses to an experimental tetravalent meningococcal diphtheria conjugate vaccine (Menactra®) in children who have received a monovalent meningococcal C conjugate vaccine at least one year previously.
Primary objective:
To describe and compare the Serum Bactericidal Assay (SBA) antibody response for serogroup C in participants receiving Menactra® to the serogroup C antibody response in a control group of participants receiving a licensed Haemophilus Influenzae Type b (Hib) conjugate vaccine 28 days following vaccination.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 2 Years 至 4 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 2 years to < 5 years of age at the time of vaccination.
- •At least one year from primary vaccination with a monovalent meningococcal C conjugate vaccine has elapsed.
- •Parent/Guardian has signed an Ethics Committee-approved informed consent form. A culturally appropriate translation will be used for non-English speaking participants where required.
排除标准
- •Serious chronic disease (i.e. cardiac, renal, neurologic, metabolic, rheumatologic, etc.)
- •Known or suspected impairment of immunologic function
- •Acute medical illness with or without fever within the last 72 hours or an axillary temperature ≥ 37.5ºC at the time of inclusion
- •History of documented invasive meningococcal disease
- •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 enrolment
- •Antibiotic therapy within the 72 hours prior to vaccination or 72 hours prior to drawing any blood sample
- •Received any vaccine in the 28-day period prior to enrolment, or scheduled to receive any vaccine during enrolment in the trial
- •Received a meningococcal C conjugate vaccine within one year prior to enrolment
- •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
Hiberix® Vaccine Group
Participants receiving Haemophilus Influenzae Type b (Hib) vaccine
干预措施: Haemophilus Influenzae Type b (Hib) vaccine (Biological)
Menactra® Vaccine Group
Participants receiving the tetravalent (A, C, Y, and W 135) meningococcal diphtheria toxoid conjugate vaccine
干预措施: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate (Biological)
结局指标
主要结局
Geometric Mean of Antibody Titers (GMTs) as Measured by Serum Bactericidal Assay (SBA) at Baseline (Day 0) and Day 28 Post-vaccination.
时间窗: Day 0 (before) and 28 days post-vaccination
次要结局
- Participants With a ≥ 4-Fold Rise in Antibody Titers as Measured by Serum Bactericidal Assay (SBA) From Baseline to Day 28 Post-vaccination.(28 days post-vaccination)