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.


CONCLUSIONS
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.
Vaccine and Immunisation Research Group (VIRGo); Melbourne School of Population and Global Health; University of Melbourne and Murdoch Children's Research Institute; Melbourne, VIC Australia.
Terry M
TM
Nolan
Queensland Paediatric Infectious Diseases Laboratory; Queensland Children's Medical Research Institute, Royal Children's Hospital; Brisbane, QLD Australia.
Michael D
MD
Nissen
Madera Family Medical Group; Madera, CA USA.
Aftab
A
Naz
Ohio Pediatric Research Association; Vandalia, OH USA.
Julie
J
Shepard
Novartis Vaccines and Diagnostics; Cambridge, MA USA.
Lisa
L
Bedell
Novartis Vaccines and Diagnostics; Cambridge, MA USA.
Matthew
M
Hohenboken
Novartis Vaccines and Diagnostics; Cambridge, MA USA.
Tatjana
T
Odrljin
Novartis Vaccines and Diagnostics; Cambridge, MA USA.
Peter M
PM
Dull
D015721:Diphtheria-Tetanus-Pertussis Vaccine / Q000008:administration & dosage; D005260:Female; D018073:Haemophilus Vaccines / Q000008:administration & dosage; D017325:Hepatitis B Vaccines / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology; D000069443:Heptavalent Pneumococcal Conjugate Vaccine; D006801:Humans; D007115:Immunization Schedule; D007223:Infant; D008297:Male; D022542:Measles-Mumps-Rubella Vaccine / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology; D022401:Meningococcal Vaccines / Q000008:administration & dosage / Q000009:adverse effects* / Q000276:immunology*; D022242:Pneumococcal Vaccines / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology; D011054:Poliovirus Vaccine, Inactivated / Q000008:administration & dosage; D016896:Treatment Outcome; D014611:Vaccination / Q000379:methods; D018074:Vaccines, Conjugate / Q000008:administration & dosage
C538862:13-valent pneumococcal vaccine; D015721:Diphtheria-Tetanus-Pertussis Vaccine; D018073:Haemophilus Vaccines; D017325:Hepatitis B Vaccines; D000069443:Heptavalent Pneumococcal Conjugate Vaccine; D022542:Measles-Mumps-Rubella Vaccine; C556088:MenACWY-CRM vaccine; D022401:Meningococcal Vaccines; D022242:Pneumococcal Vaccines; D011054:Poliovirus Vaccine, Inactivated; D018074:Vaccines, Conjugate; C541234:diphtheria-tetanus-five component acellular pertussis-inactivated poliomyelitis -Haemophilus influenzae type b conjugate vaccine
conjugate vaccine; immunogenicity; infants; meningococcal disease; safety