MenACWY-TT is immunogenic when co-administered with Tdap and AS04-HPV16/18 in girls and young women: Results from a phase III randomized trial

Vaccine. 2018 Jun 22;36(27):3967-3975. doi: 10.1016/j.vaccine.2018.05.051. Epub 2018 May 19.


Background: Co-administration of vaccines in adolescents may improve coverage. We assessed co-administration of quadrivalent meningococcal serogroups A, C, W and Y tetanus toxoid-conjugate vaccine (MenACWY-TT), human papillomavirus 16/18 AS04-adjuvanted vaccine (AS04-HPV16/18) and tetanus-diphtheria-acellular pertussis vaccine (Tdap) in girls and young women.

Methods: In this phase IIIb study (NCT01755689), 1300 healthy 9-25-year-old females were randomized (1:1:1:1:1) to receive: MenACWY-TT at month (M) 0 and AS04-HPV16/18 at M1, M2, M7; MenACWY-TT and AS04-HPV16/18 at M0 and AS04-HPV16/18 at M1, M6; AS04-HPV16/18 at M0, M1, M6; MenACWY-TT, Tdap and AS04-HPV16/18 at M0 and AS04-HPV16/18 at M1, M6; Tdap and AS04-HPV16/18 at M0 and AS04-HPV16/18 at M1, M6. Immunogenicity, safety and reactogenicity were evaluated.

Results: Immunogenicity of MenACWY-TT and AS04-HPV16/18 when co-administered was non-inferior to that of the 2 vaccines given separately. Co-administration of MenACWY-TT, AS04-HPV16/18 and Tdap was non-inferior to MenACWY-TT administered alone or to Tdap co-administered with AS04-HPV16/18 in terms of immunogenicity for all vaccine components, except pertussis antigens. Post-vaccination, ≥89.5% of participants reached antibody levels above the pre-specified threshold for all antigens. No safety concerns were identified.

Conclusion: Our data support co-administration of MenACWY-TT with Tdap and AS04-HPV16/18 vaccines in adolescents.

Keywords: Adolescent vaccination; Co-administration; Diphtheria-tetanus-acellular pertussis vaccine; HPV 16/18 AS04-adjuvanted vaccine; Quadrivalent meningococcal conjugate vaccine.

Publication types

  • Clinical Trial, Phase III
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adjuvants, Immunologic / administration & dosage
  • Adolescent
  • Adult
  • Antibodies, Bacterial / blood
  • Antibodies, Viral / blood
  • Child
  • Diphtheria-Tetanus-acellular Pertussis Vaccines / administration & dosage*
  • Diphtheria-Tetanus-acellular Pertussis Vaccines / immunology
  • Female
  • Human papillomavirus 16 / immunology
  • Human papillomavirus 18 / immunology
  • Humans
  • Immunogenicity, Vaccine / immunology*
  • Meningococcal Infections / prevention & control*
  • Meningococcal Vaccines / administration & dosage*
  • Meningococcal Vaccines / immunology
  • Neisseria meningitidis / immunology
  • Papillomavirus Infections / prevention & control*
  • Papillomavirus Vaccines / administration & dosage*
  • Papillomavirus Vaccines / immunology
  • Vaccines, Conjugate / administration & dosage
  • Vaccines, Conjugate / immunology
  • Young Adult


  • Adjuvants, Immunologic
  • Antibodies, Bacterial
  • Antibodies, Viral
  • Diphtheria-Tetanus-acellular Pertussis Vaccines
  • Meningococcal Vaccines
  • Papillomavirus Vaccines
  • Vaccines, Conjugate
  • tetravalent meningococcal serogroups A, C, W-135 and Y tetanus toxoid conjugate vaccine

Associated data