Immunogenicity and safety of one or two doses of the quadrivalent meningococcal vaccine MenACWY-TT given alone or with the 13-valent pneumococcal conjugate vaccine in toddlers: A phase III,open-label,randomised study |
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| Institution: | 1. Medical Research Council: Respiratory and Meningeal Pathogens Research Unit, Johannesburg, South Africa;2. Department of Science and Technology National Research Foundation, Vaccine Preventable Diseases, Johannesburg, South Africa;3. Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa;4. Murdoch Children''s Research Institute and Melbourne School of Population and Global Health, University of Melbourne, Carlton, Victoria 3010, Australia;5. Clinical Trials Research Center, Canadian Center for Vaccinology, Dalhousie University and the IWK Health Centre, 5850/5980 University Avenue, Halifax, NS B3K 6R8, Canada;6. Department of Pediatrics, Ege University Faculty of Medicine, 35100 Bornova, Izmir, Turkey;7. Setshaba Research Centre, 2088 Block H, Soshanguve, Pretoria 0152, South Africa;8. Division of Paediatrics, University of Western Australia and Vaccine Trials Group, Telethon Kids Institute, 100 Roberts Road, Subiaco, WA 6008, Australia;9. Adelaide Medical School and Robinson Research Institute, University of Adelaide and Vaccinology and Immunology Research Trials Unit, Women''s and Children''s Health Network, Adelaide, 72 King William Road, North Adelaide, South Australia 5006, Australia;10. Faculty of Medicine, Hacettepe University, Sihhiye 06100, Ankara, Turkey;11. GSK, 5, Embassy Links, SRT Road, Opp to Accenture, Cunningham Road, Vasanth Nagar, Bangalore, Karnataka 560052, India;13. GSK, Avenue Fleming 20 (W23), 1300 Wavre, Belgium |
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| Abstract: | BackgroundWe evaluated the immunogenicity and safety of 1 and 2 doses of quadrivalent meningococcal serogroup A, C, W and Y tetanus toxoid-conjugate vaccine (MenACWY-TT) given alone or co-administered with 13-valent pneumococcal conjugate vaccine (PCV13) in toddlers.MethodsIn this phase III, open-label, controlled, multicentre study (NCT01939158), healthy toddlers aged 12–14 months were randomised into 4 groups to receive 1 dose of MenACWY-TT at month (M) 0 (ACWY_1), 2 doses of MenACWY-TT at M0 and M2 (ACWY_2), MenACWY-TT and PCV13 at M0 (Co-ad), or PCV13 at M0 and MenACWY-TT at M2 (PCV13/ACWY). Immune responses were assessed 1 month post-each vaccination. Solicited and unsolicited symptoms were recorded for 4 and 31 days post-each vaccination, respectively; serious adverse events (SAEs) and new onset of chronic illnesses (NOCIs) up to M9 from first vaccination.Results802 toddlers were vaccinated. Post-dose 1 of MenACWY-TT, ≥92.8% of toddlers had rSBA titres ≥1:8, and ≥62.5% had hSBA titres ≥1:4 for each meningococcal serogroup. Post-dose 2 of MenACWY-TT, rSBA titres ≥1:8 were observed in ≥98.0% and hSBA titres ≥1:4 in ≥95.3% of toddlers. Percentages of toddlers with hSBA titres ≥1:4 were higher after 2 doses versus 1 dose of MenACWY-TT for MenW (97.1% versus 62.5–68.9%) and MenY (95.3% versus 64.3–67.6%). Non-inferiority of immune responses to co-administered MenACWY-TT and PCV13 over their separate administration was demonstrated. AEs incidence was comparable among groups. SAEs were reported for 4.9%, 5.1%, 5.5% and 7.5%, and NOCIs for 2.0%, 3.0%, 0.5% and 3.5% of toddlers in the ACWY_1, ACWY_2, Co-ad and PCV13/ACWY groups, respectively; 4 SAEs reported in 3 toddlers were vaccine-related. Two fatal vaccine-unrelated SAEs were reported.ConclusionMenACWY-TT was immunogenic when administered as a single dose at 12–14 months of age. A second dose in toddlers increased hSBA responses against MenW and MenY. MenACWY-TT and PCV13 can be co-administered without impairing the immunogenicity or safety profile of either vaccine. |
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