Immunogenicity and safety of a CRM-conjugated meningococcal ACWY vaccine administered concomitantly with routine vaccines starting at 2 months of age
Terry M Nolan, Michael D Nissen, Aftab Naz, Julie Shepard, Lisa Bedell, Matthew Hohenboken, Tatjana Odrljin, Peter M Dull
Human Vaccines & Immunotherapeutics | LANDES BIOSCIENCE | Published : 2014
BACKGROUND: Infants are at the highest risk for meningococcal disease and a broadly protective and safe vaccine is an unmet need in this youngest population. We evaluated the immunogenicity and safety of a 4-dose infant/toddler regimen of MenACWY-CRM given at 2, 4, 6, and 12 months of age concomitantly with pentavalent diphtheria-tetanus-acellular pertussis-Hemophilus influenzae type b-inactivated poliovirus-combination vaccine (DTaP-IPV/Hib), hepatitis B vaccine (HBV), 7- or 13-valent conjugate pneumococcal vaccine (PCV), and measles, mumps, and rubella vaccine (MMR). RESULTS: Four doses of MenACWY-CRM induced hSBA titers ≥8 in 89%, 95%, 97%, and 96% of participants against serogroups A, C,..View full abstract
T.M.N. received travel support from GSK, CSL, Novartis, Sanofi-Pasteur, and Wyeth (Pfizer) for participation in investigator meetings or for the presentation of scientific data at research meetings, and honoraria for participation in a GSK independent data monitoring and safety board for an unrelated vaccine. His institution has received project-specific research funding from the same organizations to conduct clinical trials. He is a member of the WHO SAGE (Scientific Advisory Group of Experts on immunization), and chairs the Australian Government's Australian Technical Advisory Group on Immunisation (ATAGI). M. D. N. has received travel grants from Pfizer (previously Wyeth Australia) to present independent research at international meetings, and currently and previously has been the principal investigator for clinical trials sponsored by Abbott, Baxter, CSL, GSK, MedImmune, Merck, Novartis, Sanofi-Pasteur, Wyeth, and Pfizer. L. B., M. H., T.O., and P. M. D. are employees of Novartis Vaccines and Diagnostics.