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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 ofNeisseria meningitidis
- Source :
- BMJ Open, Marshall, H S, McMillan, M, Koehler, A, Lawrence, A, MacLennan, J, Maiden, M, Ramsay, M, Ladhani, S N, Trotter, C, Borrow, R, Finn, A, Sullivan, T, Richmond, P, Kahler, C, Whelan, J & Vadivelu, K 2019, ' 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, vol. 9, no. 5, e027233 . https://doi.org/10.1136/bmjopen-2018-027233
- Publication Year :
- 2019
- Publisher :
- BMJ, 2019.
-
Abstract
- IntroductionInvasive meningococcal disease is uncommon but associated with a high-case fatality rate. Carriage prevalence of the causative bacteria,Neisseria meningitidis, is high in adolescents. A large (n=34 500) cluster randomised controlled trial (RCT) to assess the impact of a meningococcal B (MenB) vaccine on meningococcal carriage was implemented in the state of South Australia (SA) for year 10, 11 and 12 senior school students in 2017–2018. This study will assess the impact of MenB vaccine (4CMenB) on carriage prevalence in school leavers in SA, 1 and 2 years after implementation of the cluster RCT in adolescents. Measuring the impact of population programmes on carriage can assist in informing future meningococcal immunisation programmes such as targeted age groups and use of catch-up campaigns.Methods and analysisThis repeat cross-sectional study will assess carriage prevalence in 2018 and 2019. All school leavers who attended year 12 in any school in SA in 2018 or 2019 will be invited to participate in this study. An oropharyngeal swab will be taken from each participating student and a risk factor questionnaire completed by the student following informed consent. Students will attend clinics at SA universities, technical colleges, and metropolitan, rural and remote government council clinics. Confirmed vaccination history will allow a comparison in carriage prevalence between vaccinated and unvaccinated school leavers. A sample size of 4096 students per year will provide 80% power to detect a 20% difference in carriage prevalence of disease-causing meningococci (defined as genogroup A, B, C, W, X or Y) between years.Ethics and disseminationThe study was approved by the Women’s and Children’s Health Network Human Research Ethics Committee. Results will be published in international peer review journals and presented at national and international conferences.Trial registration numberNCT03419533; Pre-results
- Subjects :
- Adult
Male
medicine.medical_specialty
Adolescent
Cross-sectional study
education
Population
Meningococcal vaccines
Meningococcal Vaccines
Meningococcal vaccine
Neisseria meningitidis
Neisseria meningitidis, Serogroup B
smoking
Young Adult
03 medical and health sciences
0302 clinical medicine
Informed consent
South Australia
Case fatality rate
Protocol
Prevalence
medicine
risk factors
Humans
030212 general & internal medicine
Cluster randomised controlled trial
0303 health sciences
education.field_of_study
030306 microbiology
business.industry
Smoking
bacterial load
General Medicine
3. Good health
Meningococcal Infections
Vaccination
Infectious Diseases
Cross-Sectional Studies
Carriage
Risk factors
Family medicine
Female
business
Bacterial load
Program Evaluation
Subjects
Details
- ISSN :
- 20446055 and 03419533
- Volume :
- 9
- Database :
- OpenAIRE
- Journal :
- BMJ Open
- Accession number :
- edsair.doi.dedup.....543c229bebaabd487f292a27a95afdbc