Neisseria Meningitidis
Conditions
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.
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.
Interventions
None listed
Sponsors
University of Adelaide
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
17 Years to 25 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 2018 to 2019 | As measured by PCR in school leavers in 2018 and 2019 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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) | 2018 to 2019 | As measured by PCR in school leavers in 2018 and 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) | 2018 to 2019 | As measured by PCR in school leavers in 2018 and 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 | 2018 to 2019 | As measured by PCR in vaccinated and unvaccinated school leavers |
| 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. | 2018 to 2019 | As measured by PCR in vaccinated and unvaccinated school leavers in 2018 and 2019 |
| Identify Characteristics Associated With Carriage Prevalence of All N. Meningitidis Genogroups in South Australian School Leavers in 2018/2019 | 2018 to 2019 | As measured by PCR in school leavers |
| 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 | 2018 to 2019 | As measured by PCR in school leavers |
| 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 | 2018 to 2019 | As measured by PCR in vaccinated and unvaccinated school leavers |
Other
| Measure | Time frame | Description |
|---|---|---|
| Describe Carriage Density of N. Meningitidis Genogroups as Measured by qPCR in School Leavers | 2018 to 2019 | Density of N. meningitides by qPCR |
| Describe Genome Sequencing of Pathogenic N. Meningitidis (A, B, C, W, X, Y) in Carriage Among School Leavers. | 2018 to 2019 | Whole genome sequencing of N. meningitidis |
Countries
Australia
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 2018 School Leavers South Australian school leavers in 2018 (year 12 in 2017) | 4,107 |
| 2019 School Leavers South Australian school leavers in 2019 (year 12 in 2018) | 2,695 |
| Total | 6,802 |
Baseline characteristics
| Characteristic | 2018 School Leavers | 2019 School Leavers | Total |
|---|---|---|---|
| Age, Continuous Age | 18.45 years STANDARD_DEVIATION 0.71 | 18.49 years STANDARD_DEVIATION 0.51 | 18.47 years STANDARD_DEVIATION 0.65 |
| Race/Ethnicity, Customized Aboriginal | 60 Participants | 25 Participants | 85 Participants |
| Race/Ethnicity, Customized African | 66 Participants | 49 Participants | 115 Participants |
| Race/Ethnicity, Customized Asian | 440 Participants | 467 Participants | 907 Participants |
| Race/Ethnicity, Customized Caucasian | 3063 Participants | 1868 Participants | 4931 Participants |
| Race/Ethnicity, Customized Middle Eastern | 66 Participants | 58 Participants | 124 Participants |
| Race/Ethnicity, Customized Missing | 168 Participants | 81 Participants | 249 Participants |
| Race/Ethnicity, Customized Other | 231 Participants | 131 Participants | 362 Participants |
| Race/Ethnicity, Customized Pacific Islander | 6 Participants | 11 Participants | 17 Participants |
| Race/Ethnicity, Customized Torres Strait Islander | 7 Participants | 5 Participants | 12 Participants |
| Sex: Female, Male Female Female | 2400 Participants | 1660 Participants | 4060 Participants |
| Sex: Female, Male Female Male | 1707 Participants | 1035 Participants | 2742 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 4,104 | 0 / 2,690 |
| other Total, other adverse events | 0 / 4,104 | 0 / 2,690 |
| serious Total, serious adverse events | 0 / 4,104 | 0 / 2,690 |
Outcome results
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
Time frame: 2018 to 2019
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 2018 School Leavers | 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 | 225 Participants |
| 2019 School Leavers | 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 | 134 Participants |
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
Time frame: 2018 to 2019
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 2018 School Leavers | 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. | 339 Participants |
| 2019 School Leavers | 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. | 281 Participants |
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
Time frame: 2018 to 2019
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 2018 School Leavers | 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 | 200 Participants |
| 2019 School Leavers | 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 | 159 Participants |
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
Time frame: 2018 to 2019
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| 2018 School Leavers | 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 | Group W | 9 Participants |
| 2018 School Leavers | 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 | Group Y | 95 Participants |
| 2018 School Leavers | 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 | Group C | 11 Participants |
| 2018 School Leavers | 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 | Group E | 14 Participants |
| 2018 School Leavers | 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 | Group X | 6 Participants |
| 2018 School Leavers | 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 | Non-groupable | 139 Participants |
| 2018 School Leavers | 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 | Group B | 83 Participants |
| 2019 School Leavers | 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 | Non-groupable | 122 Participants |
| 2019 School Leavers | 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 | Group B | 67 Participants |
| 2019 School Leavers | 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 | Group C | 13 Participants |
| 2019 School Leavers | 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 | Group W | 16 Participants |
| 2019 School Leavers | 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 | Group X | 1 Participants |
| 2019 School Leavers | 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 | Group Y | 67 Participants |
| 2019 School Leavers | 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 | Group E | 16 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
Time frame: 2018 to 2019
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 2018 School Leavers | 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) | 393 Participants |
| 2019 School Leavers | 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) | 227 Participants |
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
Time frame: 2018 to 2019
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| 2018 School Leavers | 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) | Group W | 21 Participants |
| 2018 School Leavers | 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) | Group Y | 105 Participants |
| 2018 School Leavers | 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) | Group C | 16 Participants |
| 2018 School Leavers | 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) | Group E | 23 Participants |
| 2018 School Leavers | 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) | Group X | 1 Participants |
| 2018 School Leavers | 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) | Non groupable | 168 Participants |
| 2018 School Leavers | 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) | Group B | 86 Participants |
| 2019 School Leavers | 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) | Non groupable | 93 Participants |
| 2019 School Leavers | 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) | Group B | 64 Participants |
| 2019 School Leavers | 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) | Group C | 8 Participants |
| 2019 School Leavers | 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) | Group W | 4 Participants |
| 2019 School Leavers | 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) | Group X | 6 Participants |
| 2019 School Leavers | 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) | Group Y | 57 Participants |
| 2019 School Leavers | 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) | Group E | 7 Participants |
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
Time frame: 2018 to 2019
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 2018 School Leavers | Identify Characteristics Associated With Carriage Prevalence of All N. Meningitidis Genogroups in South Australian School Leavers in 2018/2019 | 268 Participants |
| 2019 School Leavers | Identify Characteristics Associated With Carriage Prevalence of All N. Meningitidis Genogroups in South Australian School Leavers in 2018/2019 | 350 Participants |
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
Time frame: 2018 to 2019
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 2018 School Leavers | 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 | 154 Participants |
| 2019 School Leavers | 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 | 204 Participants |
Other Pre-specified
Describe Carriage Density of N. Meningitidis Genogroups as Measured by qPCR in School Leavers
Density of N. meningitides by qPCR
Time frame: 2018 to 2019
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
Time frame: 2018 to 2019