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<p>Infants are vulnerable to meningococcal disease. In this open-label phase III study (NCT03632720; registered 13/8/2018), infants were randomised to quadrivalent ACWY conjugated vaccine, MenACYW-TT, at 3 and 12–13 months and four-component meningococcus group B vaccine (4CMenB) at 2, 4, and 12–13 months (Group 1), MenACYW-TT at 3 and 12–13 months and 4CMenB at 2 and 4 months (Group 2), or 4CMenB at 2, 4, and 12–13 months (Group 3). Routine vaccines were also administered per UK schedule. Primary outcome of non-inferiority of seroprotection rates against the four capsular groups (A, C, W, and Y) in Group 1 versus Group 2 at day 30 after the second vaccine dose was demonstrated with seroprotection rates ≥99% against all capsular groups in both groups. In Group 3, cross-reactivity was observed, with hSBA titres against capsular groups A and C increasing &gt;10-fold after the third 4CMenB dose. Reactogenicity was consistent with the known profiles of both vaccines; one case of anaphylaxis related to MenACYW-TT was reported and resolved without sequelae. No new safety concerns were identified.</p>

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Safety and immunogenicity of concomitant quadrivalent meningococcus ACYW-TT and meningococcus group B vaccines

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年7月1日

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  • Monica A. McArthur,
  • Adam Finn,
  • Lawrence Barnes,
  • Richard Burkimsher,
  • Katrina Cathie,
  • Eva Galiza,
  • Paul Heaton,
  • Nicholas Jacobsen,
  • Stephen Jones,
  • Sian Ludman,
  • Patrick Moore,
  • Clare Murray,
  • Daniel Owens,
  • Alexander Trotman,
  • Ray Borrow,
  • Julie Chaix,
  • Arlette Delgado,
  • Estelle Dubois,
  • Youjun Huang,
  • Olga Syrkina,
  • Betzana Zambrano,
  • Mandeep Singh Dhingra,
  • Christine Rehm

摘要

Infants are vulnerable to meningococcal disease. In this open-label phase III study (NCT03632720; registered 13/8/2018), infants were randomised to quadrivalent ACWY conjugated vaccine, MenACYW-TT, at 3 and 12–13 months and four-component meningococcus group B vaccine (4CMenB) at 2, 4, and 12–13 months (Group 1), MenACYW-TT at 3 and 12–13 months and 4CMenB at 2 and 4 months (Group 2), or 4CMenB at 2, 4, and 12–13 months (Group 3). Routine vaccines were also administered per UK schedule. Primary outcome of non-inferiority of seroprotection rates against the four capsular groups (A, C, W, and Y) in Group 1 versus Group 2 at day 30 after the second vaccine dose was demonstrated with seroprotection rates ≥99% against all capsular groups in both groups. In Group 3, cross-reactivity was observed, with hSBA titres against capsular groups A and C increasing >10-fold after the third 4CMenB dose. Reactogenicity was consistent with the known profiles of both vaccines; one case of anaphylaxis related to MenACYW-TT was reported and resolved without sequelae. No new safety concerns were identified.