The Food and Drug Administration (FDA) has approved a new ready-to-use single dose vial presentation of Menveo (meningococcal [Groups A, C, Y, W-135] oligosaccharide diphtheria CRM197 conjugate vaccine) for active immunization against invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y and W-135 in individuals 10 through 55 years of age.
The approval was based on immunogenicity data from an observer-blind randomized, multicenter controlled phase 2 trial (ClinicalTrials.gov Identifier: NCT03433482) that compared the safety and immunogenicity of Menveo 1-vial presentation to the Menveo 2-vial presentation in individuals 10 to 40 years of age. The primary endpoint was the adjusted human serum bactericidal activity (hSBA) geometric mean titers (GMTs) against Neisseria meningitidis serogroup A at day 29.
Results showed noninferiority of MenA serogroup hSBA GMTs at 28 days postvaccination for the Menveo 1-vial presentation group compared with the Menveo 2-vial presentation group. Additionally, comparable immune responses against N. meningitidis serogroups C, W-135 and Y as measured by hSBA GMTs were observed. An analysis of safety data showed no notable differences in the frequency or severity of solicited adverse reactions within 7 days after vaccination in individuals who received the 1-vial presentation vs those who received the 2-vial presentation.
Menveo 1-vial presentation will initially be available to US federal customers with broader availability expected in mid-2023. The new 1-vial presentations has a pink cap and does not require reconstitution before use. It is indicated for individuals 10 to 55 years of age.
Menveo is currently available in the 2-vial presentation which requires reconstitution before use. The 2-vial presentation is approved for active immunization against invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y and W-135 in individuals 2 months through 55 years of age.
This article originally appeared on MPR
- US FDA approves Menveo in a new single-vial presentation to help prevent disease caused by meningococcal bacteria serogroups A, C, Y, and W. News release. GlaxoSmithKline plc. Accessed October 17, 2022. https://www.gsk.com/en-gb/media/press-releases/us-fda-approves-menveo-in-a-new-single-vial-presentation-to-help-prevent-disease-caused-by-meningococcal-bacteria-serogroups-a-c-y-and-w/
- Menveo. Package insert. GlaxoSmithKline plc; 2022. Accessed October 17, 2022. https://gskpro.com/content/dam/global/hcpportal/en_US/Prescribing_Information/Menveo/pdf/MENVEO.PDF