'Be on the TEAM' Study (Teenagers Against Meningitis): protocol for a controlled clinical trial evaluating the impact of 4CMenB or MenB-fHbp vaccination on the pharyngeal carriage of meningococci in adolescents.

Capsular group B The 'Be on the TEAM' (Teenagers Against Meningitis) Study is a pragmatic, partially randomised controlled trial of 24 000 students aged 16-19 years in their penultimate year of secondary school across the UK with regional allocation to a 0+6 month schedule of 4CMenB or MenB-fHbp or to a control group. Culture-confirmed oropharyngeal carriage will be assessed at baseline and at 12 months, following which the control group will be eligible for 4CMenB vaccination. The primary outcome is the carriage prevalence of potentially pathogenic meningococci (defined as those with genogroups B, C, W, Y or X), in each vaccine group compared separately to the control group at 12 months post-enrolment, that is, 12 months after the first vaccine dose and 6 months after the second vaccine dose. Secondary outcomes include impact on carriage of: genogroup B meningococci; hyperinvasive meningococci; all meningococci; those meningococci expressing vaccine antigens and; other This study is approved by the National Health Service South Central Research Ethics Committee (18/SC/0055); the UK Health Research Authority (IRAS ID 239091) and the UK Medicines and Healthcare products Regulatory Agency. Publications arising from this study will be submitted to peer-reviewed journals. Study results will be disseminated in public forums, online, presented at local and international conferences and made available to the participating schools. ISRCTN75858406; Pre-results, EudraCT 2017-004609-42.

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Déclaration de conflit d'intérêts

Competing interests: AF reports grants from the Department of Health, during the conduct of the study; grants from Pfizer, grants from GSK, outside the submitted work. HC reports other from Sanofi Pasteur, other from IMS Health, grants from National Institute for Health Research, other from AstraZeneca, grants and other from GSK, outside the submitted work. MS reports grants from National Institute for Health Research (NIHR), non-financial support from Pfizer, during the conduct of the study; grants from Pfizer, grants from MCM, grants from GlaxoSmithKline, grants from Novavax, grants from Medimmune, grants from Janssen, outside the submitted work. SC reports salary contribution from the study NIHR grant, during the conduct of the study. SF reports personal fees were paid to his institution (with no personal payment of any kind) from AstraZeneca/Medimmune, Sanofi, Pfizer, Seqirus, Sandoz, Merck, GSK, Alios, Johnson & Johnson and Merck, outside the submitted work. RB reports grants from University of Oxford via a NIHR grant, during the conduct of the study; contract research on behalf of Public Health England for GSK, Pfizer and Sanofi Pasteur, outside the submitted work.