Business
MenABCWY vaccine preliminary phase III results
MenABCWY vaccine preliminary phase III results.
About this update from Gsk Plc
[{"type":"text","content":"\n\n \nIssued: 12 May 2023, London UK\n \nGSK presents pivotal data at ESPID confirming effectiveness of its 5-in-1 meningococcal ABCWY vaccine candidate, with demonstrated coverage against a panel of 110 MenB strains\n \n· Preliminary results from phase III trial show all primary endpoints met, demonstrating statistical non-inferiority compared to Bexsero (meningococcal group B vaccine) and Menveo (meningococcal group A, C, W-135, and Y conjugate vaccine), in individuals 10-25 years old with an acceptable safety profile\n· Only investigational 5-in-1 vaccine with demonstrated immunological effectiveness against 110 diverse MenB invasive strains in a clinical trial\n· If approved, this vaccine candidate could provide the broadest coverage against the most prevalent meningococcal serogroups and could lead to a simplified immunisation schedule\n \n \nGSK plc (LSE/NYSE: GSK) today presented preliminary positive results from the phase III trial (https://clinicaltrials.gov/ct2/show/NCT04502693) evaluating the immunological vaccine effectiveness and safety of its MenABCWY combination vaccine candidate, administered as two doses given six months apart in healthy individuals aged 10-25 years. The preliminary data were disclosed at the 41st Annual Meeting of the European Society for Paediatric Infectious Diseases (ESPID) in Lisbon, Portugal.\n \nThe vaccine candidate demonstrated non-inferiority in primary endpoints for five Neisseria meningitidis serogroups (A, B, C, W, and Y) compared to two doses of Bexsero (meningococcal group B vaccine) and one dose of Menveo (meningococcal group A, C, W-135, and Y conjugate vaccine) in 10-25-year-olds. In addition, the vaccine candidate was generally well tolerated, with a safety profile consistent with Bexsero and Menveo. In a separate confirmatory arm of this phase III trial, the MenABCWY vaccine candidate showed immunological effectiveness against a panel of 110 diverse meningococcal serogroup B (MenB) invasive strains, which account for 95% of strains circulating in the US.[1]\n \nTony Wood, Chief Scientific Officer at GSK, said: \"These preliminary data further unlock the potential of our MenABCWY vaccine candidate in providing protection against invasive meningococcal disease caused by serogroups A, B, C, W and Y. It...