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

摘要: Introduction Invasive meningococcal disease is uncommon but associated with a high-case fatality rate. Carriage prevalence of the causative bacteria, Neisseria meningitidis, high in adolescents. A large (n=34 500) cluster randomised controlled trial (RCT) to assess impact B (MenB) vaccine on carriage was implemented state South Australia (SA) for year 10, 11 and 12 senior school students 2017–2018. This study will MenB (4CMenB) leavers SA, 1 2 years after implementation RCT Measuring population programmes can assist informing future immunisation such as targeted age groups use catch-up campaigns. Methods analysis repeat cross-sectional 2018 2019. All who attended any SA or 2019 be invited participate this study. An oropharyngeal swab taken from each participating student risk factor questionnaire completed by following informed consent. Students attend clinics at universities, technical colleges, metropolitan, rural remote government council clinics. Confirmed vaccination history allow comparison between vaccinated unvaccinated leavers. sample size 4096 per provide 80% power detect 20% difference disease-causing meningococci (defined genogroup A, B, C, W, X Y) years. Ethics dissemination The approved Women’s Children’s Health Network Human Research Committee. Results published international peer review journals presented national conferences. Trial registration number NCT03419533; Pre-results