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临床试验/NCT01126996
NCT01126996已完成不适用

An Observational Study Into the Maintenance of Seroprotection Against Meningococcal Serogroup C Disease Throughout Childhood Following a Single Dose of a Conjugated Meningococcal Serogroup C Vaccine Administered to Toddlers

University of Oxford1 个研究点 分布在 1 个国家目标入组 240 人开始时间: 2010年6月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
240
试验地点
1
主要终点
Percentage of participants with rSBA titres >1:8 (correlate of protection)

研究概览

简要总结

Neisseria meningitidis occurs worldwide as endemic disease1 and is a major cause of invasive infections such as meningitis and septicaemia. Three protein-polysaccharide conjugate serogroup C meningococcal (MenC) vaccines were developed in the late 1990's and an accelerated programme of clinical trials in the UK led to licensure of these MenC vaccines in 1999 and these vaccines were introduced into the routine infant immunisation schedule at 2, 3 and 4 months. However, children who were aged 1-18 years in 2000 only received a single dose of a MenC conjugate vaccine during the mass immunisation campaign.

Previous studies have demonstrated rapid waning of MenC specific antibody concentrations and serum bactericidal antibody (SBA) titres following immunisation in young children. A cross-sectional review on rates of sero-protection against MenC disease in the UK has demonstrated that the majority of children who were immunised with a single dose of a MenC conjugate vaccine between the ages of 1-10 did not have protective titres of MenC SBA 7 years after the immunisation campaign. As this cohort of children reaches adolescence there is a risk of increased transmission of the organism and a resurgence of meningococcal disease in children who do not have protective levels of antibody. There is thus a need to conduct a study evaluating the changes in MenC SBA titres over time in children who received a single dose of a MenC vaccine in early childhood which is the main objective of this study.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
3 Years 至 9 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Participant whose parent is willing and able to give informed consent for participation in the study.
  • Participant who gives assent for participation in the study.
  • Male or Female, aged 11 to 13 years.
  • Known to be free from medical problems as determined by a medical history and clinical assessment
  • Participated in the University of Oxford clinical trial: U01-Td5I-303/ C01.183

排除标准

  • History of invasive meningococcal C disease
  • Any vaccination against MenC disease with the exception of a single dose in 2000 during the nationwide MenC immunisation campaign
  • Confirmed or suspected immunosuppressive or immunodeficient conditions, including human immunodeficiency virus (HIV) infection.
  • Major congenital defects or serious chronic illness

结局指标

主要结局

Percentage of participants with rSBA titres >1:8 (correlate of protection)

时间窗: 6 months

次要结局

  • MenC rSBA GMTs at all time points when sera is available after receiving a dose of MenC vaccine(6 months)
  • Percentage of children at each time point with MenC SBA titres >1:8(6 months)

研究者

申办方类型
Other

研究点 (1)

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