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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT03419533




Registration number
NCT03419533
Ethics application status
Date submitted
17/01/2018
Date registered
5/02/2018
Date last updated
5/11/2021

Titles & IDs
Public title
Study to Assess Oropharyngeal Carriage of N. Meningitidis in South Australian School Leavers
Scientific title
An Observational Cross-sectional Study to Assess Oropharyngeal Carriage of N. Meningitidis in South Australian School Leavers
Secondary ID [1] 0 0
HREC/16/WCHN/140_3
Universal Trial Number (UTN)
Trial acronym
B Part Of It
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Neisseria Meningitidis 0 0
Condition category
Condition code

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
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)
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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
Timepoint [1] 0 0
2018 to 2019
Secondary outcome [1] 0 0
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)
Timepoint [1] 0 0
2018 to 2019
Secondary outcome [2] 0 0
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)
Timepoint [2] 0 0
2018 to 2019
Secondary outcome [3] 0 0
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
Timepoint [3] 0 0
2018 to 2019
Secondary outcome [4] 0 0
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.
Timepoint [4] 0 0
2018 to 2019
Secondary outcome [5] 0 0
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
Timepoint [5] 0 0
2018 to 2019
Secondary outcome [6] 0 0
Identify Characteristics Associated With Carriage Prevalence of All N. Meningitidis Genogroups in South Australian School Leavers in 2018/2019
Timepoint [6] 0 0
2018 to 2019
Secondary outcome [7] 0 0
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
Timepoint [7] 0 0
2018 to 2019

Eligibility
Key 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).
Minimum age
17 Years
Maximum age
25 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- No exclusion criteria

Study design
Purpose
Duration
Cross-sectional
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/02/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
31/12/2020
Sample size
Target
Accrual to date
Final
6802
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 0 0
Women's and Children's Hosptial - Adelaide
Recruitment postcode(s) [1] 0 0
5006 - Adelaide

Funding & Sponsors
Primary sponsor type
Other
Name
University of Adelaide
Address
Country

Ethics approval
Ethics application status

Summary
Brief 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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT03419533
Trial related presentations / publications
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.
Public notes

Contacts
Principal investigator
Name 0 0
Helen Marshall
Address 0 0
University of Adelaide
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT03419533