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Completed

NCT Number: NCT03419533

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.

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Key information

Age range

17 year–25 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Women's and Children's Hosptial

Adelaide, South Australia, 5006, Australia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

    Time frame: 2018 to 2019

    As measured by PCR in school leavers in 2018 and 2019

Secondary outcomes

  1. 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)

    Time frame: 2018 to 2019

    As measured by PCR in school leavers in 2018 and 2019

  2. 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)

    Time frame: 2018 to 2019

    As measured by PCR in school leavers in 2018 and 2019

  3. 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

    Time frame: 2018 to 2019

    As measured by PCR in vaccinated and unvaccinated school leavers

  4. 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.

    Time frame: 2018 to 2019

    As measured by PCR in vaccinated and unvaccinated school leavers in 2018 and 2019

  5. 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

    Time frame: 2018 to 2019

    As measured by PCR in vaccinated and unvaccinated school leavers

  6. Identify Characteristics Associated With Carriage Prevalence of All N. Meningitidis Genogroups in South Australian School Leavers in 2018/2019

    Time frame: 2018 to 2019

    As measured by PCR in school leavers

  7. 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

    Time frame: 2018 to 2019

    As measured by PCR in school leavers

Other outcomes

  1. Describe Carriage Density of N. Meningitidis Genogroups as Measured by qPCR in School Leavers

    Time frame: 2018 to 2019

    Density of N. meningitides by qPCR

  2. Describe Genome Sequencing of Pathogenic N. Meningitidis (A, B, C, W, X, Y) in Carriage Among School Leavers.

    Time frame: 2018 to 2019

    Whole genome sequencing of N. meningitidis

Sponsors and collaborators

Lead sponsor

University of Adelaide

Other

Registry information

Official study title

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

Acronym: B Part Of It

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Feb 5, 2018
Registry last updated
Nov 5, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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