title: Quadrivalent meningococcal (MenACWY-TT) conjugate vaccine or a fourth dose of H. influenzae-N. meningitidis C/Y conjugate vaccine (HibMenCY-TT) is immunogenic in toddlers who previously received three doses of HibMenCY-TT in infancy.
abstract: BACKGROUND
  Immunogenicity and safety of a single dose of MenACWY-TT or a fourth dose of HibMenCY-TT were evaluated in the second year of life in HibMenCY-TT-primed toddlers.
  
  
  METHODS
  Healthy infants were randomized (5:1) and primed at 2, 4 and 6 months of age with HibMenCY-TT and diphtheria-tetanus-acellular pertussis-hepatitis B-inactivated poliovirus (DTaP-HBV-IPV) vaccine; or Hib-TT and DTaP-HBV-IPV (control). Recipients of HibMenCY-TT+DTaP-HBV-IPV were re-randomized (2:2:1) to receive MenACWY-TT at 12-15 months and DTaP at 15-18 months; MenACWY-TT co-administered with DTaP at 15-18 months; or HibMenCY-TT at 12-15 months and DTaP at 15-18 months. Controls received DTaP only at 15-18 months due to Hib conjugate vaccine shortage. Serum bactericidal activity using human complement (hSBA) and safety were assessed one month after meningococcal vaccination.
  
  
  RESULTS
  After vaccination with MenACWY-TT at 12-15 months or MenACWY-TT+DTaP at 15-18 months, all subjects previously primed for serogroups C/Y had hSBA ≥1:8 for these serogroups. At least 96.1% also had hSBA ≥1:8 for serogroups A/W. All subjects in the HibMenCY-TT group had hSBA ≥1:8 for serogroups C/Y. All pre-defined statistical criteria for meningococcal immunogenicity were satisfied. All vaccination regimens had acceptable safety profiles.
  
  
  CONCLUSIONS
  Children primed with three doses of HibMenCY-TT who then received a single dose of MenACWY-TT or a fourth dose of HibMenCY-TT had robust increases in hSBA titers for serogroups C/Y. These data provide support that MenACWY-TT, given with or without the fourth scheduled dose of DTaP could be administered as an alternative to a fourth dose of HibMenCY-TT in the second year of life. This study (110870/110871) is registered at www.clinicaltrials.gov NCT00614614.
authors.affiliation: Palmetto Pediatrics, 2781 Tricom St, North Charleston, SC 29406, United States. Electronic address: mikeyleonardi@yahoo.com.
authors.forename: Michael
authors.initials: M
authors.lastname: Leonardi
authors.affiliation: ACC Pediatric Research, Oak Thicket Shopping Center, 1025 Highway 80 East Haughton, Bossier City, LA 71037, United States.
authors.forename: Thomas
authors.initials: T
authors.lastname: Latiolais
authors.affiliation: Division of General Academic Pediatrics, University of Texas Medical Branch at Galveston, 301 University Blvd, Galveston, TX 77555, United States.
authors.forename: Kwabena
authors.initials: K
authors.lastname: Sarpong
authors.affiliation: Baptist Health Lexington, 1740 Nicholasville Road, Lexington, KY 40503, United States.
authors.forename: Michael
authors.initials: M
authors.lastname: Simon
authors.affiliation: Dixie Pediatrics, 1240 E 100 S Suite 14, Saint George, UT 84790, United States.
authors.forename: Jerry
authors.initials: J
authors.lastname: Twiggs
authors.affiliation: Jordan Valley Medical Center, 3580 West 9000 South, West Jordan, UT 84088, United States.
authors.forename: Paul
authors.initials: P
authors.lastname: Lei
authors.affiliation: 30 E Hickman Road, Waukee, IA 50263, United States.
authors.forename: Stephen
authors.initials: S
authors.lastname: Rinderknecht
authors.affiliation: Saint Clair Hospital, 1000 Bower Hill Road, Pittsburgh, PA 15243, United States.
authors.forename: Mark
authors.initials: M
authors.lastname: Blatter
authors.affiliation: GlaxoSmithKline Vaccines, Rue Fleming 20, Wavre 1300, Belgium.
authors.forename: Veronique
authors.initials: V
authors.lastname: Bianco
authors.affiliation: GlaxoSmithKline Vaccines, 2301 Renaissance Blvd, RN0220, King of Prussia, PA 19406, United States.
authors.forename: Yaela
authors.initials: Y
authors.lastname: Baine
authors.affiliation: GlaxoSmithKline Vaccines, 2301 Renaissance Blvd, RN0220, King of Prussia, PA 19406, United States.
authors.forename: Leonard R
authors.initials: LR
authors.lastname: Friedland
authors.affiliation: GlaxoSmithKline Vaccines, 2301 Renaissance Blvd, RN0220, King of Prussia, PA 19406, United States.
authors.forename: Jacqueline M
authors.initials: JM
authors.lastname: Miller
mesh_terms: D004334:Drug Administration Schedule; D005260:Female; D018073:Haemophilus Vaccines / Q000008:administration & dosage* / Q000276:immunology*; D006801:Humans; D007223:Infant; D008297:Male; D022401:Meningococcal Vaccines / Q000008:administration & dosage* / Q000276:immunology*; D013745:Tetanus Toxoid / Q000008:administration & dosage* / Q000276:immunology*; D018074:Vaccines, Conjugate / Q000008:administration & dosage / Q000276:immunology
chemical_list: D018073:Haemophilus Vaccines; C527605:Hib-MenCY-TT vaccine; D022401:Meningococcal Vaccines; D013745:Tetanus Toxoid; D018074:Vaccines, Conjugate; C576777:tetravalent meningococcal serogroups A, C, W-135 and Y tetanus toxoid conjugate vaccine
keywords: ACWY; Conjugate vaccine; HibMenCY; Quadrivalent meningococcal vaccine; Serum bactericidal activity