N/A
N=6,802
Study to Assess Oropharyngeal Carriage of N. Meningitidis in South Australian School Leavers
Neisseria Meningitidis
Bottom Line
View on ClinicalTrials.gov: NCT03419533 ↗Enrolled (actual)
6,802
Serious AEs
0.0%
Results posted
Nov 2021
Primary outcome: 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 — 225; 134 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Pediatric, Adult · 17+ yrs
- Sex
- All
- Sponsor
- University of Adelaide
- Primary completion
- Dec 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| 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 |
225; 134 | — |
| 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) |
393; 227 | — |
| 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) |
86; 64; 16; 8; 21; 4 | — |
| 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 |
200; 159 | — |
| 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. |
339; 281 | — |
| 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 |
83; 67; 11; 13; 9; 16 | — |
| SECONDARY Identify Characteristics Associated With Carriage Prevalence of All N. Meningitidis Genogroups in South Australian School Leavers in 2018/2019 |
268; 350 | — |
| 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 |
154; 204 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03419533). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.