PMID- 24220326
OWN - NLM
STAT- MEDLINE
DCOM- 20150105
LR  - 20211021
IS  - 2164-554X (Electronic)
IS  - 2164-5515 (Print)
IS  - 2164-5515 (Linking)
VI  - 10
IP  - 2
DP  - 2014
TI  - Immunogenicity and safety of a CRM-conjugated meningococcal ACWY vaccine 
      administered concomitantly with routine vaccines starting at 2 months of age.
PG  - 280-9
LID - 10.4161/hv.27051 [doi]
AB  - 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.
FAU - Nolan, Terry M
AU  - Nolan TM
AD  - 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.
FAU - Nissen, Michael D
AU  - Nissen MD
AD  - Queensland Paediatric Infectious Diseases Laboratory; Queensland Children's 
      Medical Research Institute, Royal Children's Hospital; Brisbane, QLD Australia.
FAU - Naz, Aftab
AU  - Naz A
AD  - Madera Family Medical Group; Madera, CA USA.
FAU - Shepard, Julie
AU  - Shepard J
AD  - Ohio Pediatric Research Association; Vandalia, OH USA.
FAU - Bedell, Lisa
AU  - Bedell L
AD  - Novartis Vaccines and Diagnostics; Cambridge, MA USA.
FAU - Hohenboken, Matthew
AU  - Hohenboken M
AD  - Novartis Vaccines and Diagnostics; Cambridge, MA USA.
FAU - Odrljin, Tatjana
AU  - Odrljin T
AD  - Novartis Vaccines and Diagnostics; Cambridge, MA USA.
FAU - Dull, Peter M
AU  - Dull PM
AD  - Novartis Vaccines and Diagnostics; Cambridge, MA USA.
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
DEP - 20131112
PL  - United States
TA  - Hum Vaccin Immunother
JT  - Human vaccines & immunotherapeutics
JID - 101572652
RN  - 0 (13-valent pneumococcal vaccine)
RN  - 0 (Diphtheria-Tetanus-Pertussis Vaccine)
RN  - 0 (Haemophilus Vaccines)
RN  - 0 (Hepatitis B Vaccines)
RN  - 0 (Heptavalent Pneumococcal Conjugate Vaccine)
RN  - 0 (Measles-Mumps-Rubella Vaccine)
RN  - 0 (MenACWY-CRM vaccine)
RN  - 0 (Meningococcal Vaccines)
RN  - 0 (Pneumococcal Vaccines)
RN  - 0 (Poliovirus Vaccine, Inactivated)
RN  - 0 (Vaccines, Conjugate)
RN  - 0 (diphtheria-tetanus-five component acellular pertussis-inactivated 
      poliomyelitis -Haemophilus influenzae type b conjugate vaccine)
SB  - IM
MH  - Diphtheria-Tetanus-Pertussis Vaccine/administration & dosage
MH  - Female
MH  - Haemophilus Vaccines/administration & dosage
MH  - Hepatitis B Vaccines/administration & dosage/adverse effects/immunology
MH  - Heptavalent Pneumococcal Conjugate Vaccine
MH  - Humans
MH  - *Immunization Schedule
MH  - Infant
MH  - Male
MH  - Measles-Mumps-Rubella Vaccine/administration & dosage/adverse effects/immunology
MH  - Meningococcal Vaccines/administration & dosage/*adverse effects/*immunology
MH  - Pneumococcal Vaccines/administration & dosage/adverse effects/immunology
MH  - Poliovirus Vaccine, Inactivated/administration & dosage
MH  - Treatment Outcome
MH  - Vaccination/methods
MH  - Vaccines, Conjugate/administration & dosage
PMC - PMC4185919
OTO - NOTNLM
OT  - conjugate vaccine
OT  - immunogenicity
OT  - infants
OT  - meningococcal disease
OT  - safety
EDAT- 2013/11/14 06:00
MHDA- 2015/01/06 06:00
PMCR- 2015/02/01
CRDT- 2013/11/14 06:00
PHST- 2013/11/14 06:00 [entrez]
PHST- 2013/11/14 06:00 [pubmed]
PHST- 2015/01/06 06:00 [medline]
PHST- 2015/02/01 00:00 [pmc-release]
AID - 27051 [pii]
AID - 2013HV0303R [pii]
AID - 10.4161/hv.27051 [doi]
PST - ppublish
SO  - Hum Vaccin Immunother. 2014;10(2):280-9. doi: 10.4161/hv.27051. Epub 2013 Nov 12.