Evaluation of the Persistence in 2016 of Vaccinal Immunity Against Meningococcus C Among Children and Teenagers Who Received Meningococcus C Conjugate Vaccine in January 2002 During the Puy-de-Dôme Campaign and of Natural Immunity Among Unvaccinated People
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 184
- 试验地点
- 2
- 主要终点
- Evaluation in 2016 of immunity's level (antibodies) against meningococcus C among people vaccinated in 2002 in Puy-de-Dôme
研究概览
简要总结
Meningococcus C vaccine was first used in France to prevent epidemics. It was a success in Puy-de-Dôme, Landes, Pyrénées Atlantiques and Hautes Pyrénées. Following many European countries, France introduced meningococcus C conjugate vaccine in 2009 but this recommendation was not suffiicently applied (6,6% of the 20-25 years-old were vaccinated in 2015).
The situation in France is very different from UK and there is no data on the subject. The vaccination campaign in 2002 in Puy-de-Dôme offers much more detachment, possible comparison between vaccinated and unvaccinated people, among which meningococcus circulation could maintain immunity. This is the reason why we have decided to assess in 2016 the vaccinal and natural immunity among Puy-de-Dôme population.
详细描述
People were recruited during hospitalisation or consultation of Pediatric, Occupational Medecine, Infectiology departments of Clermont Ferrand Hospital or Health Service of Auvergne's University, from March to September 2016.
Doctors gave informations about the study and collected consents before blood tests were done (two tubes of 4,5mL each).
Blood tests were daily collected and freezed. Then they were analysed at Meningococcus National Reference Center, in Paris.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 13 Years 至 39 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •- people from 13 to 39 years old
- •who received meningococcus C conjugate vaccine in 2002 in Puy-de-Dôme (vaccinated group) or not (unvaccinated group)
排除标准
- •vaccination before or after 2002 containing meningococcus C valence
- •refusal to participate
研究组 & 干预措施
vaccinated group
evaluation of immunity's level against meningococcus C among people vaccinated in 2002 in Puy-de-Dôme
干预措施: Meningococcus C conjugate vaccine (Other)
unvaccinate group
Duration of vaccinal immunity, compare vaccinal immunity to possible natural immunity among unvaccinated people
干预措施: Meningococcus C conjugate vaccine (Other)
结局指标
主要结局
Evaluation in 2016 of immunity's level (antibodies) against meningococcus C among people vaccinated in 2002 in Puy-de-Dôme
时间窗: at day 1
次要结局
- Evaluate the duration (years) of vaccinal immunity(at day 1)
- Compare vaccinal immunity to possible natural immunity (antibodies level) among unvaccinated people(at day 1)
- Determine the cutt-off (age) for which vaccinal immunity is still protective (sufficient antibodies level)(at day 1)
- Adjust results on sociodemographic data (age, sex, city, number of years spent in Puy de Dôme, Auvergne, France and abroad from 2002 to 2016)(at day 1)