Sanofi posts Phase 3 meningococcal vaccine results; also logs label update and new trials

Sanofi's week included one trial reporting results, a generic drug label change, and two studies newly appearing in registries.

• The Phase 3 trial comparing MenACYW conjugate vaccine (MenQuadfi) to Nimenrix in a 1+1 schedule for infants and toddlers, designed to support a 2-dose series for immunization of individuals from 6 months of age¹, is now listed as completed with results first posted October 7, 2026. The study enrolled 840 participants actual.¹ It evaluated non-inferiority of the immune response of MenACYW conjugate vaccine versus Nimenrix after a priming dose at 6-7 months and a booster at 12-13 months.¹
• A labeling supplement for Encube's generic Diclofenac Sodium 1% topical gel (ANDA210986, supplement 27) was approved by the FDA, with a submission status date of October 5, 2026.
• Sanofi's Phase 4, open-label study of the Omicron subvariant-based Nuvaxovid vaccine with Matrix-M, registered as NCT07861542, remains not yet recruiting. The trial will test a single dose in participants 65 and older and those 12 through 64 with conditions raising COVID-19 risk, who had a prior COVID-19 vaccine at least 90 days earlier², with an estimated enrollment of 660 and an estimated start of October 2, 2026.
• Sanofi appears as a collaborator, not sponsor, on LYSO-NEXT (NCT07863479), a diagnostic study led by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico. The study uses genetic sequencing to identify undiagnosed lysosomal storage disorders in adults with unexplained neurological symptoms³, and is listed as active, not recruiting, with 1,000 participants enrolled.