Antibody Responses Following Meningococcal Tetravalent (A, C, Y, and W-135) Conjugate Vaccination in Healthy Adults Who Were Either Previously Vaccinated With Unconjugated Meningococcal Polysaccharide (Serogroups A, C or Serogroups A, C, Y, and W-135) Vaccine or Not Vaccinated With Meningococcal Vaccine
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- Participants With a ≥ 4-fold Rise in Antibody Titers as Measured by Serum Bactericidal Assay (SBA) From Day 0 to Day 28.
研究概览
简要总结
This study was designed to generate data for the assessment of Meningococcal Polysaccharide Diphtheria Toxoid Conjugate vaccine (Menactra®) when given to adults aged 18 to 55 years.
Primary Objective:
To describe the antibody response to each serogroup prior to, and 4 to 6 weeks following, the administration of one dose of the investigational Meningococcal Polysaccharide Diphtheria Toxoid Conjugate vaccine (Menactra®), as measured by serum bactericidal activity using baby rabbit complement (SBA BR) in participants in each of the two study groups.
Secondary Objective:
To collect reference sera for the development and refinement of laboratory assays for the measurement of antibody responses to serogroups Y and W 135.
详细描述
Enrollment was terminated before the planned sample size was achieved because the principal investigator and the Sponsor decided that sufficient sera had been obtained to meet the secondary objective of the study.
There were no safety concerns involved in the decision to stop enrollment. Subjects that were enrolled at the time completed the study as per protocol, the last subject last visit was on 29 April 2004.
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
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Participants With a ≥ 4-fold Rise in Antibody Titers as Measured by Serum Bactericidal Assay (SBA) From Day 0 to Day 28.
时间窗: Day 28 post-vaccination
Number of participants with a minimum of 4 fold rise in Antibody Titers as Measured SBA to each vaccine meningococcal serogroups from Baseline to Day 28.
次要结局
未报告次要终点