title: Immunogenicity and reactogenicity of Infanrix™ when co-administered with meningococcal MenACWY-TT conjugate vaccine in toddlers primed with MenHibrix™ and Pediarix™.
abstract: BACKGROUND
  Co-administration of an investigational quadrivalent meningococcal serogroups A, C, W and Y tetanus toxoid conjugate vaccine (MenACWY-TT) with the fourth dose of diphtheria-tetanus-acellular pertussis vaccine (DTaP) at age 15-18 months was investigated in 3-dose Haemophilus influenzae type b-meningococcal serogroups C/Y conjugate vaccine (HibMenCY-TT)-primed toddlers.
  
  
  METHODS
  Infants were randomized (5:1) and primed at 2, 4 and 6 months of age with HibMenCY-TT and DTaP-hepatitis B-inactivated poliovirus (DTaP-HBV-IPV) vaccine, or Hib-TT and DTaP-HBV-IPV (Control). HibMenCY-TT+ DTaP-HBV-IPV vaccinees were re-randomized (2:2:1) to receive MenACWY-TT at 12-15 months and DTaP at 15-18 months (MenACWY-TT group); MenACWY-TT co-administered with DTaP at 15-18 months (Coad group); or HibMenCY-TT at 12-15 months and DTaP at 15-18 months (HibMenCY-TT group). Controls received DTaP at 15-18 months. Only children in the HibMenCY-TT group received a fourth dose of Hib conjugate vaccine due to Hib conjugate vaccine shortage at the time of the study. DTaP immunogenicity and reactogenicity were assessed one month post-vaccination.
  
  
  RESULTS
  Pre-defined statistical non-inferiority criteria between Coad and Control groups were met for diphtheria, tetanus and filamentous haemagglutinin but not pertussis toxoid and pertactin. Following vaccination ≥99% of children had anti-diphtheria/anti-tetanus concentrations ≥1.0 IU/ml. Pertussis GMCs were lower in all investigational groups versus Control. In post hoc analyses, pertussis antibody concentrations were above those in infants following 3-dose DTaP primary vaccination in whom efficacy against pertussis was demonstrated (Schmitt, von König, et al., 1996; Schmitt, Schuind, et al., 1996). The reactogenicity profile of the Coad group was similar to DTaP administered alone.
  
  
  CONCLUSIONS
  Routine booster DTaP was immunogenic with an acceptable safety profile when co-administered with MenACWY-TT vaccine in HibMenCY-TT-primed toddlers. These data support the administration of a fourth DTaP dose following a 4-dose HibMenCY-TT vaccination series, or co-administered with MenACWY-TT in HibMenCY-TT-primed children.
authors.affiliation: Palmetto Pediatrics, 2781 Tricom Street, 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 Boulevard, 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: 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 Boulevard, RN0220, King of Prussia, PA 19406, United States.
authors.forename: Yaela
authors.initials: Y
authors.lastname: Baine
authors.affiliation: GlaxoSmithKline Vaccines, 2301 Renaissance Boulevard, RN0220, King of Prussia, PA 19406, United States.
authors.forename: Leonard R
authors.initials: LR
authors.lastname: Friedland
authors.affiliation: GlaxoSmithKline Vaccines, 2301 Renaissance Boulevard, RN0220, King of Prussia, PA 19406, United States.
authors.forename: Carmen
authors.initials: C
authors.lastname: Baccarini
authors.affiliation: GlaxoSmithKline Vaccines, 2301 Renaissance Boulevard, RN0220, King of Prussia, PA 19406, United States.
authors.forename: Jacqueline M
authors.initials: JM
authors.lastname: Miller
mesh_terms: D015721:Diphtheria-Tetanus-Pertussis Vaccine / Q000276:immunology*; D022681:Diphtheria-Tetanus-acellular Pertussis Vaccines / Q000009:adverse effects* / Q000276:immunology*; D004334:Drug Administration Schedule; D005260:Female; D018073:Haemophilus Vaccines / Q000276:immunology*; D017325:Hepatitis B Vaccines / Q000276:immunology*; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D008297:Male; D022401:Meningococcal Vaccines / Q000008:administration & dosage* / Q000276:immunology*; D011054:Poliovirus Vaccine, Inactivated / Q000276:immunology*; D013745:Tetanus Toxoid / Q000276:immunology*; D018074:Vaccines, Conjugate / Q000276:immunology
chemical_list: D015721:Diphtheria-Tetanus-Pertussis Vaccine; D022681:Diphtheria-Tetanus-acellular Pertussis Vaccines; D018073:Haemophilus Vaccines; D017325:Hepatitis B Vaccines; C527605:Hib-MenCY-TT vaccine; D022401:Meningococcal Vaccines; C472675:PEDIARIX; D011054:Poliovirus Vaccine, Inactivated; D013745:Tetanus Toxoid; D018074:Vaccines, Conjugate; C576777:tetravalent meningococcal serogroups A, C, W-135 and Y tetanus toxoid conjugate vaccine
keywords: Co-administration; DTaP vaccine; HibMenCY-TT; MenACWY-TT; Quadrivalent meningococcal vaccine