NCT03419533

Study to Assess Oropharyngeal Carriage of N. Meningitidis in South Australian School Leavers

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 6,802 (actual)
• Sponsor: University of Adelaide · Academic / Other
• Sex: All
• Age: 17 Years – 25 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Neisseria Meningitidis

Timeline

• Start date: 2018-02-01
• Primary completion: 2020-12-31
• Completion: 2020-12-31
• First posted: 2018-02-05
• Last updated: 2021-11-05
• Results posted: 2021-11-05

Locations

1 site across 1 country: Australia