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GSK touts early Phase III data for 5-in-1 meningococcal vaccine candidate

2023-05-12

疫苗临床3期临床结果优先审批信使RNA

GSK on Friday reported preliminary data from a Phase III trial of its MenABCWY vaccine candidate, which targets the five Neisseria meningitidis serogroups that account for nearly all invasive meningococcal disease cases in most of the world. If approved, the jab could provide "the broadest coverage against the most prevalent meningococcal serogroups and could lead to a simplified immunisation schedule," the company said.

Findings from the trial, which began in 2020, were unveiled at the European Society for Paediatric Infectious Diseases (ESPID) conference. "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," remarked chief scientific officer Tony Wood, adding "it's particularly encouraging to see the breadth of coverage against the broadest panel of circulating MenB (meningococcal group B) strains to date."

The randomised study enrolled 3657 children and young adults ranging in age from 10 to 25 years old, with MenABCWY administered as two doses given six months apart. There are a total of 11 primary endpoints, five for MenABCWY and six for Bexsero, GSK's already licensed MenB vaccine. Bexsero is used as the comparator for the MenB immune responses induced by MenABCWY in the study. The trial is also serving as the confirmatory trial for Bexsero in the US.

GSK said its pentavalent vaccine demonstrated non-inferiority in primary endpoints for the N. meningitidis serogroups A, B, C, W and Y, compared to two doses of Bexsero and one dose of its Menveo jab, which prevents invasive meningococcal disease caused by serogroups A, C, Y and W-135. The MenABCWY jab was also generally well tolerated, with a safety profile consistent with Bexsero and Menveo.

Pfizer rival jab under review

In a separate confirmatory arm of the trial, GSK said MenABCWY showed immunological effectiveness against a panel of 110 diverse MenB invasive strains account for 95% of those circulating in the US. The company indicated it is working with regulatory agencies to review the full Phase III dataset. Detailed results will be submitted to a peer-reviewed scientific journal later this year.

Currently, Pfizer markets the MenB vaccine Trumenba, while Sanofi's portfolio includes the MenACWY vaccines Menactra and MenQuadfi. Late last year, the FDA agreed to review a filing seeking approval of Pfizer's pentavalent MenABCWY vaccine candidate for use in young people, with a decision due this October. That application is based on a Phase III trial involving 2431 healthy adolescents and young adults that met all of its primary and secondary endpoints.

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