Immunogenicity and safety of a CRM-conjugated meningococcal ACWY vaccine administered concomitantly with routine vaccines starting at 2 months of age.
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, W-135, and Y, respectively. hSBA titers ≥8 were present in 76-98% of participants after the first 3 doses. A categorical linear analysis incorporating vaccine group and study center showed responses to routine vaccines administered with MenACWY-CRM were non-inferior to routine vaccines alone, except for seroresponse to the pertussis antigen fimbriae. The reactogenicity profile was not affected when MenACWY-CRM was administered concomitantly with routine vaccines.


CONCLUSION
MenACWY-CRM administered with routine concomitant vaccinations in young infants was well tolerated and induced highly immunogenic responses against each of the serogroups without significant interference with the immune responses to routine infant vaccinations.


METHODS
Healthy 2 month old infants were randomized to receive MenACWY-CRM with routine vaccines (n = 258) or routine vaccines alone (n = 271). Immunogenicity was assessed by serum bactericidal assay using human complement (hSBA). Medically attended adverse events (AEs), serious AEs (SAEs) and AEs leading to study withdrawal were collected throughout the study period.
['Nolan|Terry M|TM|', 'Nissen|Michael D|MD|', 'Naz|Aftab|A|', 'Shepard|Julie|J|', 'Bedell|Lisa|L|', 'Hohenboken|Matthew|M|', 'Odrljin|Tatjana|T|', 'Dull|Peter M|PM|']
D015721:Diphtheria-Tetanus-Pertussis Vaccine D005260:Female D018073:Haemophilus Vaccines D017325:Hepatitis B Vaccines D000069443:Heptavalent Pneumococcal Conjugate Vaccine D006801:Humans D007115:Immunization Schedule D007223:Infant D008297:Male D022542:Measles-Mumps-Rubella Vaccine D022401:Meningococcal Vaccines D022242:Pneumococcal Vaccines D011054:Poliovirus Vaccine, Inactivated D016896:Treatment Outcome D014611:Vaccination D018074:Vaccines, Conjugate
immunogenicity safety infants meningococcal disease conjugate vaccine