A Study to Evaluate the Long-term Antibody Persistence at 1, 3 & 5 Years After the Administration of a Fourth Dose of Hib-MenCY-TT Vaccine Compared to ActHIB in Subjects Boosted in a Previous Study.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 270
- 试验地点
- 22
- 主要终点
- Number of Subjects With Neisseria Meningitidis Serogroup Y (MenY) Antibody Titers Greater Than or Equal to 1:8 as Measured by Serum Bactericidal Assay Using Human Complement (hSBA)
研究概览
简要总结
This study is evaluating antibody persistence at 1, 3 & 5 years post-fourth dose (i.e., at 2, 4 & 6 years of age, respectively) in subjects vaccinated in a previous study.
This protocol posting deals with objectives & outcome measures of the extension phase at years 1, 3 and 5. The objectives & outcome measures of the first four doses are presented in a separate protocol posting (NCT00129129).
This protocol posting has been amended in order to comply with the FDA Amendment Act of September 26, 2007.
详细描述
In this long-term follow-up study, no new subjects will be recruited. All subjects participating in this long-term follow-up study should have already participated in a previous study. No vaccine will be administered during the persistence phase of the study.
This Protocol Posting has been updated following Protocol amendment 3, September 2009.
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
- 22 Months 至 60 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male and female children who completed the previous four dose vaccination series study (NCT00129129). The age of the child at the 3 post-fourth dose timelines are as follows:
- •Year 1: 22 to 36 months of age.
- •Year 3: 44 to 60 months of age.
- •Year 5: 5 years post-dose 4 +/- 8 weeks
- •Written informed consent obtained from the parent or guardian of the subject.
- •Healthy subjects as established by medical history and clinical examination before entering into the study
- •Having completed the fourth dose vaccination of study Hib-MenCY-TT-005/006
排除标准
- •Children should not have:
- •received more than 4 doses of Hib or meningococcal serogroup C and Y vaccine
- •had a history of H. influenzae type b, meningococcal serogroup C and Y diseases
结局指标
主要结局
Number of Subjects With Neisseria Meningitidis Serogroup Y (MenY) Antibody Titers Greater Than or Equal to 1:8 as Measured by Serum Bactericidal Assay Using Human Complement (hSBA)
时间窗: One year, three years, and five years after the fourth dose vaccination.
Results up to 5 years after the fourth dose are presented.
Number of Subjects With Anti- Polyribosylribitol Phosphate (Anti-PRP) Antibody Concentrations Greater Than or Equal to 0.15 Microgram Per Milliliter
时间窗: One year, three years, and five years after the fourth dose vaccination.
Results up to 5 years after the fourth dose are presented.
Number of Subjects With Neisseria Meningitidis Serogroup C (MenC) Antibody Titers Greater Than or Equal to 1:8 as Measured by Serum Bactericidal Assay Using Human Complement (hSBA)
时间窗: One year, three years, and five years after the fourth dose vaccination.
Results up to 5 years after the fourth dose are presented.
次要结局
- hSBA-MenY Geometric Mean Titers (GMTs)(One year, three years, and five years after the fourth dose vaccination.)
- Anti-PRP Geometric Mean Concentrations (GMCs)(One year, three years, and five years after the fourth dose vaccination.)
- Number of Subjects With Anti-PRP Antibody Concentrations Greater Than or Equal to 1.0 Microgram Per Milliliter(One year, three years, and five years after the fourth dose vaccination.)
- hSBA-MenC Geometric Mean Titers (GMTs)(One year, three years, and five years after the fourth dose vaccination.)
- Number of Subjects With hSBA-MenC Titers Greater Than or Equal to 1:4(One year, three years, and five years after the fourth dose vaccination.)
- Number of Subjects With hSBA-MenY Titers Greater Than or Equal to 1:4(One year, three years, and five years after the fourth dose vaccination.)