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

作者：Rivera Luis; Chanthavanich Pornthep; Poder Airi; Suryakiran P V; Jastorff Archana; Van der Wielen Marie^*

来源：Vaccine, 2018, 36(27): 3967-3975.

DOI：10.1016/j.vaccine.2018.05.051

• Quadrivalent meningococcal conjugate
• vaccine
• HPV 16/18 AS04-adjuvanted vaccine
• Diphtheria-tetanus-acellular pertussis
• vaccine
• Co-administration
• Adolescent vaccination

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 Ml, M2, M7; MenACWY-TT and AS04-HPV16/18 at MO and AS04-HPV16/18 at Ml, M6; AS04-HPV16/18 at MO, Ml, M6; MenACWY-TT, Tdap and AS04-HPV16/18 at MO and AS04-HPV16/18 at Ml, M6; Tdap and AS04-HPV16/18 at MO and AS04-HPV16/18 at Ml, 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.

• 出版日期2018-6-22