Trial Outcomes & Findings for Study to Assess Oropharyngeal Carriage of N. Meningitidis in South Australian School Leavers (NCT NCT03419533)
NCT ID: NCT03419533
Last Updated: 2021-11-05
Results Overview
As measured by PCR in school leavers in 2018 and 2019
Recruitment status
COMPLETED
Target enrollment
6802 participants
Primary outcome timeframe
2018 to 2019
Results posted on
2021-11-05
Participant Flow
Participant milestones
| Measure |
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)
|
|---|---|---|
|
Overall Study
STARTED
|
4107
|
2695
|
|
Overall Study
COMPLETED
|
4107
|
2695
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study to Assess Oropharyngeal Carriage of N. Meningitidis in South Australian School Leavers
Baseline characteristics by cohort
| Measure |
2018 School Leavers
n=4107 Participants
South Australian school leavers in 2018 (year 12 in 2017)
|
2019 School Leavers
n=2695 Participants
South Australian school leavers in 2019 (year 12 in 2018)
|
Total
n=6802 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
Age
|
18.45 years
STANDARD_DEVIATION 0.71 • n=5 Participants
|
18.49 years
STANDARD_DEVIATION 0.51 • n=7 Participants
|
18.47 years
STANDARD_DEVIATION 0.65 • n=5 Participants
|
|
Sex: Female, Male
Female · Female
|
2400 Participants
n=5 Participants
|
1660 Participants
n=7 Participants
|
4060 Participants
n=5 Participants
|
|
Sex: Female, Male
Female · Male
|
1707 Participants
n=5 Participants
|
1035 Participants
n=7 Participants
|
2742 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Aboriginal
|
60 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
85 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Torres Strait Islander
|
7 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
3063 Participants
n=5 Participants
|
1868 Participants
n=7 Participants
|
4931 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
440 Participants
n=5 Participants
|
467 Participants
n=7 Participants
|
907 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Middle Eastern
|
66 Participants
n=5 Participants
|
58 Participants
n=7 Participants
|
124 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African
|
66 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
115 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Pacific Islander
|
6 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
231 Participants
n=5 Participants
|
131 Participants
n=7 Participants
|
362 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Missing
|
168 Participants
n=5 Participants
|
81 Participants
n=7 Participants
|
249 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2018 to 2019As measured by PCR in school leavers in 2018 and 2019
Outcome measures
| Measure |
2018 School Leavers
n=4104 Participants
Disease associated genogroups
|
2019 School Leavers
n=2690 Participants
Disease associated genogroups
|
|---|---|---|
|
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
|
134 Participants
|
SECONDARY outcome
Timeframe: 2018 to 2019As measured by PCR in school leavers in 2018 and 2019
Outcome measures
| Measure |
2018 School Leavers
n=4104 Participants
Disease associated genogroups
|
2019 School Leavers
n=2690 Participants
Disease associated genogroups
|
|---|---|---|
|
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
|
227 Participants
|
SECONDARY outcome
Timeframe: 2018 to 2019As measured by PCR in school leavers in 2018 and 2019
Outcome measures
| Measure |
2018 School Leavers
n=4104 Participants
Disease associated genogroups
|
2019 School Leavers
n=2690 Participants
Disease associated genogroups
|
|---|---|---|
|
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
|
7 Participants
|
|
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
|
64 Participants
|
|
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
|
8 Participants
|
|
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
|
4 Participants
|
|
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
|
6 Participants
|
|
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
|
57 Participants
|
|
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
|
93 Participants
|
SECONDARY outcome
Timeframe: 2018 to 2019As measured by PCR in vaccinated and unvaccinated school leavers
Outcome measures
| Measure |
2018 School Leavers
n=3885 Participants
Disease associated genogroups
|
2019 School Leavers
n=2909 Participants
Disease associated genogroups
|
|---|---|---|
|
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
|
159 Participants
|
SECONDARY outcome
Timeframe: 2018 to 2019As measured by PCR in vaccinated and unvaccinated school leavers in 2018 and 2019
Outcome measures
| Measure |
2018 School Leavers
n=3885 Participants
Disease associated genogroups
|
2019 School Leavers
n=2909 Participants
Disease associated genogroups
|
|---|---|---|
|
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
|
281 Participants
|
SECONDARY outcome
Timeframe: 2018 to 2019As measured by PCR in vaccinated and unvaccinated school leavers
Outcome measures
| Measure |
2018 School Leavers
n=3885 Participants
Disease associated genogroups
|
2019 School Leavers
n=2909 Participants
Disease associated genogroups
|
|---|---|---|
|
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
|
16 Participants
|
|
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
|
122 Participants
|
|
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
|
67 Participants
|
|
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
|
13 Participants
|
|
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
|
16 Participants
|
|
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
|
1 Participants
|
|
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
|
67 Participants
|
SECONDARY outcome
Timeframe: 2018 to 2019As measured by PCR in school leavers
Outcome measures
| Measure |
2018 School Leavers
n=2709 Participants
Disease associated genogroups
|
2019 School Leavers
n=4055 Participants
Disease associated genogroups
|
|---|---|---|
|
Identify Characteristics Associated With Carriage Prevalence of All N. Meningitidis Genogroups in South Australian School Leavers in 2018/2019
|
268 Participants
|
350 Participants
|
SECONDARY outcome
Timeframe: 2018 to 2019As measured by PCR in school leavers
Outcome measures
| Measure |
2018 School Leavers
n=2709 Participants
Disease associated genogroups
|
2019 School Leavers
n=4055 Participants
Disease associated genogroups
|
|---|---|---|
|
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
|
204 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 2018 to 2019Density of N. meningitides by qPCR
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 2018 to 2019Whole genome sequencing of N. meningitidis
Outcome measures
Outcome data not reported
Adverse Events
2018 School Leavers
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
2019 School Leavers
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place