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Peer-reviewedCC BYnpj Vaccines

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

  • Monica A. McArthur1
  • Adam Finn2
  • Lawrence Barnes3
  • Richard Burkimsher4
  • Katrina Cathie5
  • Eva Galiza6
  • Paul Heaton7
  • Nicholas Jacobsen8
  • Stephen Jones9
  • Sian Ludman10
  • Patrick Moore11
  • Clare Murray12
11 more authors
  • Daniel Owens5
  • Alexander Trotman13
  • Ray Borrow14
  • Julie Chaix15
  • Arlette Delgado16
  • Estelle Dubois17
  • Youjun Huang18
  • Olga Syrkina19
  • Betzana Zambrano1
  • Mandeep Singh Dhingra1
  • Christine Rehm1
19 affiliations
  1. 1Global Clinical Development Strategy, Sanofi
  2. 2Bristol Vaccine Centre, Schools of Population Health Sciences and Cellular and Molecular Medicine, University of Bristol and Bristol Royal Hospital for Children, University Hospitals Bristol NHS Foundation Trust
  3. 3Rame Medical Limited, Penntorr Health
  4. 4Mounts Bay Medical Ltd, Connor Downs Surgery, Connor Downs, Hayle
  5. 5National Institute for Health Research Southampton Clinical Research Facility and Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust, and Faculty of Medicine and Institute for Life Sciences, University of Southampton
  6. 6Vaccine Institute, City St George’s, University of London
  7. 7Department of Paediatrics, Yeovil District Hospital, Yeovil
  8. 8Newquay Health Centre, Newquay
  9. 9Royal United Hospital, Combe Park, Bath
  10. 10Royal Devon University Hospital
  11. 11The Adam Practice, Poole
  12. 12Royal Manchester Children’s Hospital, Manchester University NHS Foundation Trust, and Division of Immunology, Immunity to Infection and Respiratory Medicine, University of Manchester
  13. 13Chaddlewood Surgery, Plympton
  14. 14Vaccine Evaluation Unit, UK Health Security Agency
  15. 15Global Clinical Immunology, Sanofi
  16. 16Global Pharmacovigilance-Vaccines, IQVIA; and Patient Safety & Pharmacovigilance, Sanofi
  17. 17Global Clinical Operations, Sanofi
  18. 18Evidence Generation and Decision Sciences, Sanofi
  19. 19Patient Safety and Pharmacovigilance, Sanofi R&D
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Abstract

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.

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Cite

BibTeXRIS
BibTeX
@article{mcarthur2026safety,
  title = {{Safety and immunogenicity of concomitant quadrivalent meningococcus ACYW-TT and meningococcus group B vaccines}},
  author = {Monica A. McArthur and Adam Finn and Lawrence Barnes and Richard Burkimsher and Katrina Cathie and Eva Galiza and Paul Heaton and Nicholas Jacobsen and Stephen Jones and Sian Ludman and Patrick Moore and Clare Murray and Daniel Owens and Alexander Trotman and Ray Borrow and Julie Chaix and Arlette Delgado and Estelle Dubois and Youjun Huang and Olga Syrkina and Betzana Zambrano and Mandeep Singh Dhingra and Christine Rehm},
  journal = {npj Vaccines},
  year = {2026},
  month = jul,
  doi = {10.1038/s41541-026-01508-7},
  url = {https://doi.org/10.1038/s41541-026-01508-7},
  note = {CC BY},
}
RIS
TY  - JOUR
TI  - Safety and immunogenicity of concomitant quadrivalent meningococcus ACYW-TT and meningococcus group B vaccines
AU  - Monica A. McArthur
AU  - Adam Finn
AU  - Lawrence Barnes
AU  - Richard Burkimsher
AU  - Katrina Cathie
AU  - Eva Galiza
AU  - Paul Heaton
AU  - Nicholas Jacobsen
AU  - Stephen Jones
AU  - Sian Ludman
AU  - Patrick Moore
AU  - Clare Murray
AU  - Daniel Owens
AU  - Alexander Trotman
AU  - Ray Borrow
AU  - Julie Chaix
AU  - Arlette Delgado
AU  - Estelle Dubois
AU  - Youjun Huang
AU  - Olga Syrkina
AU  - Betzana Zambrano
AU  - Mandeep Singh Dhingra
AU  - Christine Rehm
PY  - 2026
DA  - 2026/07/01
JO  - npj Vaccines
DO  - 10.1038/s41541-026-01508-7
UR  - https://doi.org/10.1038/s41541-026-01508-7
AB  - 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.
SN  - 2059-0105
ER  -