Luis Rivera1, Pornthep Chanthavanich2, Airi Põder3, P V Suryakiran4, Archana Jastorff5, Marie Van der Wielen6. 1. Hospital Maternidad Nuestra Señora de la Altagracia, Av. Pedro Henríquez Ureña 49, Santo Domingo, Dominican Republic. Electronic address: lrp@claro.net.do. 2. Department of Tropical Pediatrics, Faculty of Tropical Medicine, Mahidol University, 420/6 Ratchawithi Road, Ratchathewi, Bangkok 10400, Thailand. Electronic address: pornthep.cha@mahidol.ac.th. 3. Clinical Research Center, Sõbra tn 54, Tartu 50160, Estonia. Electronic address: airi.poder@std.ee. 4. GSK Wavre, Avenue Fleming 20 (W23), 1300 Wavre, Belgium. Electronic address: p.v.suryakiran@gsk.com. 5. GSK Wavre, Avenue Fleming 20 (W23), 1300 Wavre, Belgium. Electronic address: archana.m.jastorff@gsk.com. 6. GSK Wavre, Avenue Fleming 20 (W23), 1300 Wavre, Belgium. Electronic address: marie.x.van-der-wielen@gsk.com.
Abstract
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.
RCT Entities:
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.
Authors: James T Peterson; Agnieszka M Zareba; David Fitz-Patrick; Brandon J Essink; Daniel A Scott; Kena A Swanson; Dhawal Chelani; David Radley; David Cooper; Kathrin U Jansen; Philip R Dormitzer; William C Gruber; Alejandra Gurtman Journal: J Infect Dis Date: 2022-06-15 Impact factor: 7.759