Evaluation of Meningococcal C Vaccine Programmes in Canadian (BC, NS, Alta.) Children During Peak Years of Risk (0-<5 Years of Age)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 452
- 试验地点
- 3
- 主要终点
- To evaluate the longest lasting protection against Meningococcal C disease and to see if a booster vaccination is needed.
研究概览
简要总结
The purpose of the study is to see which of the three current provincial Meningococcal C Conjugate vaccine schedules in Canada provide the longest lasting protection against Meningococcal C disease and to see if a booster vaccination is needed.
详细描述
In 2002-2005, Canada introduced universal MenC programmes consisting of 1,2 or 3 infant doses. Most are one (12 mth) dose. High rates of serogroupC disease in 2000 and 2001 prompted some provinces to launch universal MenC vaccination programmes in 2002. The goal was to provide protection in infancy and early childhood (the time of most risk) with the hope that the protection would extend throughout adolescence (the second highest risk). It is unclear if early multi-dosing or 1 dose programmes would offer better protection (lack of data). Each province in Canada has chosen different Meningococcal C Conjugate vaccine provision schedules for the primary vaccinations.
This study will look at short term protection after the differing provincial series of vaccinations has been given and compare those who do not get primary vaccination under 1 year of age (NS) with two schedules of primary immunization (BC at 2 and 4 mths and Alberta at 2 months). A blood sample will be collected at 12-13 mths for this comparison. A booster vaccination of the current provincial Men C vaccine will be provided at 12 months. Another blood sample will be collected 1 mth later to look at the difference in responses between the groups (different provincial primary vaccination schedule). 2 years and 4 years later (at age 3 and age 5), another blood sample will be collected to look at the difference in long term protection of the groups where the primary schedule was different.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 盲法
- None
入排标准
- 年龄范围
- 12 Months 至 13 Months(Child)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •12-13 mths of age
- •over 34 weeks gestation
- •healthy children
- •having had all vaccinations of Meningococcal C vaccine per the recommended schedule for their respective province within a month of the recommended age - documented.
- •Communication in English
排除标准
- •No contraindication to receiving 12 mth dose of MenC vaccine
- •No other MenC vaccine or MenC disease
结局指标
主要结局
To evaluate the longest lasting protection against Meningococcal C disease and to see if a booster vaccination is needed.
时间窗: 4 years
次要结局
未报告次要终点
