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Study to Assess Oropharyngeal Carriage of N. Meningitidis in South Australian School Leavers (B Part Of It)

2021年10月10日 更新者:Helen Marshall、University of Adelaide

An Observational Cross-sectional Study to Assess Oropharyngeal Carriage of N. Meningitidis in South Australian School Leavers

This is an observational cross sectional study to evaluate the impact of a 4CMenB vaccination program on oropharyngeal N. meningitidis carriage in vaccinated and unvaccinated school leavers.

研究概览

地位

完全的

详细说明

This carriage study of a cohort of school leavers in South Australia (SA) will provide an opportunity to assess carriage rates in the young adult population (school leavers) following introduction of a 4CMenB vaccination program in senior school students from 2017-2018.This will allow a comparison of carriage prevalence in the two years (2018 and 2019) following implementation of the school program to assess impact on carriage at a population level and compare carriage prevalence in vaccinated versus non-vaccinated groups. Assessment of any association between risk factors and prevalence of nasopharyngeal carriage in school leavers will be made and compared between vaccinated and unvaccinated students.

School leavers are defined as students who were enrolled in year 12 at school in the preceding year of recruitment and have been chosen as they are likely to have the highest carriage rates. A high proportion (approximately two thirds) of students will be immunised by the time of throat swab collection in years 2018 and 2019. Assessing carriage in both vaccinated and unvaccinated cohorts will further inform the effect of 4CMenB vaccine on carriage at a population level. This will help determine any herd immunity impact of 4CMenB vaccine and persistence of any effect.

研究类型

观察性的

注册 (实际的)

6802

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • South Australia
      • Adelaide、South Australia、澳大利亚、5006
        • Women's and Children's Hosptial

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

17年 至 25年 (孩子、成人)

接受健康志愿者

是的

有资格学习的性别

全部

取样方法

非概率样本

研究人群

School leavers recruited through tertiary education sites and mail out through schools.

描述

Inclusion Criteria:

  • South Australian school leavers between 17 to 25 years of age (enrolled in year 12 in the previous year ie year 2018, students are eligible if they were enrolled in year 12 in 2017, year 2019, students are eligible if they were enrolled in year 12 in 2018).

Exclusion Criteria:

  • No exclusion criteria

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

队列和干预

团体/队列
2018 school leavers
South Australian school leavers in 2018 (year 12 in 2017)
2019 school leavers
South Australian school leavers in 2019 (year 12 in 2018)

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Estimate the Difference in Carriage Prevalence of Disease Associated Genogroups of N. Meningitidis (A, B, C, W, X, Y) Between School Leavers in 2018 (Year 12 in 2017) and 2019 (Year 12 in 2018), Following a 4CMenB School Immunisation Program
大体时间:2018 to 2019
As measured by PCR in school leavers in 2018 and 2019
2018 to 2019

次要结果测量

结果测量
措施说明
大体时间
Estimate the Difference in Carriage Prevalence of All N. Meningitidis Genogroups Between South Australian School Leavers in 2018 (Year 12 in 2017) and 2019 (Year 12 in 2018)
大体时间:2018 to 2019
As measured by PCR in school leavers in 2018 and 2019
2018 to 2019
Estimate the Difference in Carriage Prevalence of Each N. Meningitidis Genogroup (A, B, C, W, X, Y) Between South Australian School Leavers in 2018 (Year 12 in 2017) and 2019 (Year 12 in 2018)
大体时间:2018 to 2019
As measured by PCR in school leavers in 2018 and 2019
2018 to 2019
Across Years, Estimate the Difference in Carriage Prevalence of N. Meningitidis Genogroups Causing Disease (A, B, C, W, X, Y) Between South Australian School Leavers Who Received 4CMenB Vaccine and Unvaccinated Students
大体时间:2018 to 2019
As measured by PCR in vaccinated and unvaccinated school leavers
2018 to 2019
Across Years, Estimate the Difference in Carriage Prevalence of All N. Meningitidis Genogroups Between South Australian School Leavers Who Have Received 4CMenB and Unvaccinated Students.
大体时间:2018 to 2019
As measured by PCR in vaccinated and unvaccinated school leavers in 2018 and 2019
2018 to 2019
Across Years, Estimate the Difference in Each N. Meningitidis Genogroup (A, B, C, W, X, Y) Carriage Prevalence Between South Australian School Leavers Who Received 4CMenB Vaccine and Unvaccinated Students
大体时间:2018 to 2019
As measured by PCR in vaccinated and unvaccinated school leavers
2018 to 2019
Identify Characteristics Associated With Carriage Prevalence of All N. Meningitidis Genogroups in South Australian School Leavers in 2018/2019
大体时间:2018 to 2019
As measured by PCR in school leavers
2018 to 2019
Identify Characteristics Associated With Carriage Prevalence of N. Meningitidis Genogroups Causing Disease (A, B, C, W, X, Y) in South Australian School Leavers in 2018 /2019
大体时间:2018 to 2019
As measured by PCR in school leavers
2018 to 2019

其他结果措施

结果测量
措施说明
大体时间
Describe Carriage Density of N. Meningitidis Genogroups as Measured by qPCR in School Leavers
大体时间:2018 to 2019
Density of N. meningitides by qPCR
2018 to 2019
Describe Genome Sequencing of Pathogenic N. Meningitidis (A, B, C, W, X, Y) in Carriage Among School Leavers.
大体时间:2018 to 2019
Whole genome sequencing of N. meningitidis
2018 to 2019

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2018年2月1日

初级完成 (实际的)

2020年12月31日

研究完成 (实际的)

2020年12月31日

研究注册日期

首次提交

2018年1月17日

首先提交符合 QC 标准的

2018年1月26日

首次发布 (实际的)

2018年2月5日

研究记录更新

最后更新发布 (实际的)

2021年11月5日

上次提交的符合 QC 标准的更新

2021年10月10日

最后验证

2021年10月1日

更多信息

与本研究相关的术语

其他研究编号

  • HREC/16/WCHN/140_3

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

未定

药物和器械信息、研究文件

研究美国 FDA 监管的药品

研究美国 FDA 监管的设备产品

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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