Study design and participants
This was a phase IIIb, open-label, partially randomized, parallel-group, active-controlled, multicenter study to evaluate the immunogenicity and safety of a booster dose of MenACYW-TT when administered alone or co-administered with licensed MenB vaccines in adolescents and adults (WHO Universal Trial Number [UTN]: U1111-1217-2137; Clinicaltrials.gov, NCT04084769). The study was conducted between September 2019 and September 2020 at 29 centers in the United States and 1 center in Puerto Rico.The study was approved by the appropriate independent ethics committees and institutional review boards before its initiation. The conduct of this study was consistent with standards established by the Declaration of Helsinki and compliant with the International Conference on Harmonization guidelines for Good Clinical Practice, including all local and/or national regulations, and directives.Participants were eligible for inclusion if they were aged ≥13 to <26 years on the day of screening, and had participated in and completed any of two previous studies of MenACYW-TT (MenQuadfi®; Sanofi, Swiftwater, Pennsylvania) in the US (MET50 [NCT02199691] or MET43 [NCT02842853]),