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Positive phase III results for MenABCWY vaccine
Positive phase III results for MenABCWY vaccine.
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[{"type":"text","content":"\n \n \n Issued: 14 March 2023, London UK\n \n \n \n \n \n \n \n \n \n \n \n \n \n GSK announces positive pivotal phase III data for 5-in-1 Meningococcal ABCWY vaccine candidate\n \n \n \n \n \n \n ·\n MenABCWY combination vaccine candidate met all 11 primary endpoints of the pivotal phase III clinical trial\n and was well tolerated with a safety profile consistent with Bexsero and Menveo\n \n \n ·\n The primary endpoint data demonstrated statistical non-inferiority compared to Bexsero and Menveo in individuals 10-25 years old, with the 5-in-1 vaccine candidate eliciting a clinically meaningful immune response\n \n \n ·\n If approved, this 5-in-1 vaccine candidate could provide the broadest meningococcal serogroup coverage and could lead to a simplified immunisation schedule\n \n \n \n \n \n \n \n \n \n GSK plc (LSE/NYSE: GSK) today\n announced positive headline results from the phase III trial (\n \n \n NCT04502693\n \n \n ) evaluating the safety, tolerability, and immunogenicity of its\n MenABCWY combination vaccine candidate,\n administered as two doses given six months apart\n in healthy individuals aged 10-25 years.\n GSK's MenABCWY vaccine candidate combines the antigenic components of its licensed meningococcal vaccines, Bexsero (MenB) and Menveo (MenACWY).\n All primary endpoints were met, including the non-inferiority\n of the vaccine candidate for all five\n \n Neisseria meningitides\n \n serogroups (A, B, C, W, and Y)\n compared\n to licensed meningococcal vaccines Bexsero and Menveo in terms of an immune response. In addition, the vaccine candidate was well tolerated, with a safety profile consistent with Bexsero and Menveo.\n \n \n \n \n \n Invasive meningococcal disease (IMD), a major cause of meningitis and septicaemia\n ,\n is an uncommon but serious illness that can cause life-threatening complications or even death, typically amongst previously healthy children and adolescents.1 Among those contracting meningococcal diseases, one in ten will die, sometimes in as little as 24 hours, despite treatment.2 One-in-five survivors suffers long-term consequences, such as brain damage, amputations, hearing loss and nervous system problem\n s.1\n \n \n \n \n \n Five Neisseria meningitides serogroups (A, B, C, W, and Y) account for nearly all IMD cases in most of the world.3 As yet, no l...