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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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) |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Describe Carriage Density of N. Meningitidis Genogroups as Measured by qPCR in School Leavers | 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. |
Inclusion Criteria:
Exclusion Criteria:
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School leavers recruited through tertiary education sites and mail out through schools.
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| Name | Affiliation | Role |
|---|---|---|
| Helen Marshall | University of Adelaide | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Women's and Children's Hosptial | Adelaide | South Australia | 5006 | Australia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31064808 | Background | 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. | |
| 35895880 |
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| ID | Title | Description |
|---|---|---|
| FG000 | 2018 School Leavers | South Australian school leavers in 2018 (year 12 in 2017) |
| FG001 | 2019 School Leavers | South Australian school leavers in 2019 (year 12 in 2018) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 2018 School Leavers | South Australian school leavers in 2018 (year 12 in 2017) |
| BG001 | 2019 School Leavers | South Australian school leavers in 2019 (year 12 in 2018) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Posted | Count of Participants | Participants | 2018 to 2019 |
|
2 years
No adverse effects expected
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 2018 School Leavers | South Australian school leavers in 2018 (year 12 in 2017) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Prof. Helen Marshall | The University of Adelaide | 8161 8115 | helen.marshall@adelaide.edu.au |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 7, 2017 | Oct 10, 2021 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 8, 2019 | Oct 10, 2021 | SAP_001.pdf |
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Oropharyngeal throat swabs
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 | 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. | 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 | 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 | 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 | As measured by PCR in school leavers | 2018 to 2019 |
Whole genome sequencing of N. meningitidis
| 2018 to 2019 |
| Derived |
| McMillan M, Bednarz J, Leong LEX, Lawrence A, Marshall HS. Impact of COVID-19 Containment Strategies and Meningococcal Conjugate ACWY Vaccination on Meningococcal Carriage in Adolescents. Pediatr Infect Dis J. 2022 Nov 1;41(11):e468-e474. doi: 10.1097/INF.0000000000003660. Epub 2022 Jul 27. |
| 34487174 | Derived | McMillan M, Koehler AP, Lawrence A, Sullivan TR, Bednarz J, MacLennan JM, Maiden MCJ, Ladhani SN, Ramsay ME, Trotter C, Borrow R, Finn A, Kahler CM, Whelan J, Vadivelu K, Richmond PC, Marshall HS. B Part of It School Leaver Study: A Repeat Cross-Sectional Study to Assess the Impact of Increasing Coverage With Meningococcal B (4CMenB) Vaccine on Carriage of Neisseria meningitidis. J Infect Dis. 2022 Feb 15;225(4):637-649. doi: 10.1093/infdis/jiab444. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Units | Counts |
|---|
| Participants |
|
|
| 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 | Posted | Count of Participants | Participants | 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 | Posted | Count of Participants | Participants | 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 | Posted | Count of Participants | Participants | 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 | Posted | Count of Participants | Participants | 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 | Posted | Count of Participants | Participants | 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 | Posted | Count of Participants | Participants | 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 | Posted | Count of Participants | Participants | 2018 to 2019 |
|
|
|
| Other Pre-specified | Describe Carriage Density of N. Meningitidis Genogroups as Measured by qPCR in School Leavers | Density of N. meningitides by qPCR | Not Posted | 2018 to 2019 | Participants |
| Other Pre-specified | Describe Genome Sequencing of Pathogenic N. Meningitidis (A, B, C, W, X, Y) in Carriage Among School Leavers. | Whole genome sequencing of N. meningitidis | Not Posted | 2018 to 2019 | Participants |
| 0 |
| 4,104 |
| 0 |
| 4,104 |
| 0 |
| 4,104 |
| EG001 | 2019 School Leavers | South Australian school leavers in 2019 (year 12 in 2018) | 0 | 2,690 | 0 | 2,690 | 0 | 2,690 |
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| Group W |
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| Group X |
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| Group Y |
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| Group E |
|
| Non groupable |
|
| Group W |
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| Group X |
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| Group Y |
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| Group E |
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| Non-groupable |
|