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

Neisseria Meningitidis Clinical Trial

— B Part Of It  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03419533
• Other study ID #: HREC/16/WCHN/140_3
• Status: Completed
• Start date: February 1, 2018
• Est. completion date: December 31, 2020

Study information

• Verified date: October 2021
• Source: University of Adelaide
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6802
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 17 Years to 25 Years

Eligibility

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

Related Conditions & MeSH terms

• Neisseria Meningitidis

Locations

Country	Name	City	State
Australia	Women's and Children's Hosptial	Adelaide	South Australia

Sponsors (1)

Lead Sponsor	Collaborator
University of Adelaide

Country where clinical trial is conducted

Australia, 

References & Publications (1)

Marshall HS, McMillan M, Koehler A, Lawrence A, MacLennan J, Maiden M, Ramsay M, Ladhani SN, Trotter C, Borrow R, Finn A, Sullivan T, Richmond P, Kahler C, Whelan J, Vadivelu K. B Part of It School Leaver protocol: an observational repeat cross-sectional study to assess the impact of a meningococcal serogroup B (4CMenB) vaccine programme on carriage of Neisseria meningitidis. BMJ Open. 2019 May 6;9(5):e027233. doi: 10.1136/bmjopen-2018-027233. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Describe Carriage Density of N. Meningitidis Genogroups as Measured by qPCR in School Leavers	Density of N. meningitides by qPCR	2018 to 2019
Other	Describe Genome Sequencing of Pathogenic N. Meningitidis (A, B, C, W, X, Y) in Carriage Among School Leavers.	Whole genome sequencing of N. meningitidis	2018 to 2019
Primary	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	As measured by PCR in school leavers in 2018 and 2019	2018 to 2019
Secondary	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)	As measured by PCR in school leavers in 2018 and 2019	2018 to 2019
Secondary	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)	As measured by PCR in school leavers in 2018 and 2019	2018 to 2019
Secondary	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	As measured by PCR in vaccinated and unvaccinated school leavers	2018 to 2019
Secondary	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.	As measured by PCR in vaccinated and unvaccinated school leavers in 2018 and 2019	2018 to 2019
Secondary	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	As measured by PCR in vaccinated and unvaccinated school leavers	2018 to 2019
Secondary	Identify Characteristics Associated With Carriage Prevalence of All N. Meningitidis Genogroups in South Australian School Leavers in 2018/2019	As measured by PCR in school leavers	2018 to 2019
Secondary	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	As measured by PCR in school leavers	2018 to 2019