Objectives and endpoints
injection-site
ADVERSE EVENTS, EVENTS
The trial had two primary objectives. First, to demonstrate the immune responses to meningococcal serogroups A, C, W and Y generated by NmCV-5 were non-inferior to those generated by MenACWY-D. Second, to demonstrate the immune responses to meningococcal serogroup X generated by NmCV-5 were non-inferior to the lowest immune response generated by MenACWY-D against serogroups A, C, W and Y. Comparison to the lowest response generated against the serogroups in MenACWY-D was made following regulatory agreement in the absence of a licensed serogroup X comparator vaccine. Serum samples collected pre- and on day 28 post-vaccination were tested for serogroup-specific serum bactericidal activity using rabbit complement (rSBA).Solicited injection-site and systemic adverse events were collected and graded for severity on the day of vaccination and for a further six days post-vaccination through home-visits conducted by trained fieldworkers. Unsolicited adverse events were collected by study clinicians from the day of vaccination and for a further 28 days post-vaccination and were graded for severity. Solicited systemic events and unsolicited events were judged by the investigator for relatedness to vaccination. Serious adverse events (SAE) were collected for 168 days post-vaccination (