A Phase 2b, Open-Label, Multi-Center Study to Evaluate the Persistence of Antibody Response and to Assess the Immune Response to a Booster Dose of MenACWY Conjugate Vaccine in Subjects Previously Vaccinated as Adolescents With Either MenACWY Conjugate Vaccine or Menomune®.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 155
- 试验地点
- 3
- 主要终点
- Geometric Mean Titer After Booster Vaccination
研究概览
简要总结
The primary objective is to evaluate the persistence of bactericidal antibodies in adolescent subjects who completed study V59P6 in which they received either Novartis Meningococcal (MenACWY) Conjugate Vaccine or Licensed polysaccharide Men ACWY vaccine (Menomune®). The study will also enroll age-matched subjects who have never received any other meningococcal vaccine (naïve subjects) to serve as an additional control group.
详细描述
Persistence of antibody response at 5 years after one dose of MenACWY or Menomune
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
- 16 Years 至 23 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy adolescents or adults (age 16-23 years inclusive), either previously enrolled in the parent study or naïve to meningococcal vaccination.
- •Female subjects were to be negative for pregnancy
排除标准
- •History of meningococcal disease
- •Receipt of any meningococcal vaccine outside of parent study (V59P6)
- •Serious, acute, or chronic illnesses including HIV infection/disease and any malignancy
- •receipt of any vaccine 14 days prior to the study, or expected through the duration of the study
- •any condition which in the eyes of the investigator would pose a health risk to the subject or render them inappropriate for a research study
结局指标
主要结局
Geometric Mean Titer After Booster Vaccination
时间窗: Day 8, Day 29 (5 years after primary vaccination)
Immunogenicity was measured by serum bactericidal assay with human complement (hSBA) and reported as hSBA Geometric mean titer (GMT) in previously vaccinated subjects and in age-matched meningococcal vaccine-naive subjects. Sera was tested against Neisseria meningitidis serogroups A, C, W-135 and Y
Percentage of Participants With Serum Bactericidal Activity >=8 at 5 Years After Primary Vaccination
时间窗: Day 1 (5 years after primary vaccination)
Persistence of antibody response was measured by the percentage of subjects who showed a serum bactericidal activity with human complement(hSBA) \>= 8 \[i.e. percentage of subjects with hsBA titer \>=8\] in previously vaccinated subjects and in age-matched meningococcal vaccine naive subjects. Sera was tested against Neisseria meningitidis serogroups A, C, W-135 and Y
次要结局
- Geometric Mean Ratio After Booster Vaccination(Day 8 and Day 29 (at 5 Years After Primary Vaccination))
- Number of Participants With at Least One Reactogenicity Sign After Booster Vaccination(Up to Day 7)
- Percentage of Subjects With hSBA Seroresponse After Booster Vaccination(Day 8, Day 29 (5 years after primary vaccination))
- Percentage of Participants With Serum Bactericidal Activity >=4 at 5 Years After Primary Vaccination(Day 1 (5 years after primary vaccination ))
- Geometric Mean Titer at 5 Years After Primary Vaccination(Day 1 (5 years after primary vaccination ))
- Percentage of Participants With Serum Bactericidal Activity >=4 After Booster Vaccination(Day 7, Day 28 post booster (5 years after primary vaccination))
- Percentage of Participants With Serum Bactericidal Activity >=8 After Booster Vaccination(Day 7, Day 28 post booster (5 years after primary vaccination))