title: Immunogenicity, Safety, and Tolerability of a Hexavalent Vaccine in Infants.
abstract: BACKGROUND
  DTaP5-IPV-Hib-HepB is a fully liquid investigational hexavalent vaccine directed against 6 diseases.
  
  
  METHODS
  This multicenter, open-label, comparator-controlled, phase III study randomly assigned healthy infants 2-to-1 as follows: group 1 received DTaP5-IPV-Hib-HepB, PCV13, and RV5 at 2, 4, and 6 months of age followed by DTaP5, Hib-OMP, and PCV13 at 15 months of age; group 2 received DTaP5-IPV/Hib, PCV13, and RV5 at 2, 4, and 6 months of age, with HepB at 2 and 6 months of age, followed by DTaP5, Hib-TT, and PCV13 at 15 months of age.
  
  
  RESULTS
  Overall, 981 participants were vaccinated in group 1 and 484 in group 2. Immune responses in group 1 to all antigens contained in DTaP5-IPV-Hib-HepB 1 month after dose 3 and for concomitant rotavirus vaccine were noninferior to those in group 2, with the exception of antipertussis filamentous hemagglutinin (FHA) geometric mean concentrations (GMCs). Vaccine response rates for FHA were noninferior to control. After the toddler dose, group 1 immune responses were noninferior to group 2 for all pertussis antigens. Solicited adverse event rates after any dose were similar in both groups, with the exceptions of increased injection-site erythema, increased fever, and decreased appetite in group 1. Fever was not associated with hospitalization or seizures.
  
  
  CONCLUSIONS
  The safety and immunogenicity of DTaP5-IPV-Hib-HepB are comparable with the analogous licensed component vaccines. Decreased FHA GMCs and increased injection-site reactions and fever are unlikely to be clinically significant. DTaP5-IPV-Hib-HepB provides a new combination vaccine option aligned with the recommended US infant immunization schedule.
authors.affiliation: Department of Pediatrics, University of Louisville, Louisville, Kentucky;
authors.forename: Gary S
authors.initials: GS
authors.lastname: Marshall
authors.affiliation: Blue Ridge Pediatric and Adolescent Medicine, Boone, North Carolina;
authors.forename: Gregory L
authors.initials: GL
authors.lastname: Adams
authors.affiliation: Palmetto Pediatrics, Charleston, South Carolina;
authors.forename: Michael L
authors.initials: ML
authors.lastname: Leonardi
authors.affiliation: Merck & Co, Inc, Kenilworth, New Jersey; and.
authors.forename: Maria
authors.initials: M
authors.lastname: Petrecz
authors.affiliation: Merck & Co, Inc, Kenilworth, New Jersey; and.
authors.forename: Sheryl A
authors.initials: SA
authors.lastname: Flores
authors.affiliation: Merck & Co, Inc, Kenilworth, New Jersey; and.
authors.forename: Angela L
authors.initials: AL
authors.lastname: Ngai
authors.affiliation: Merck & Co, Inc, Kenilworth, New Jersey; and.
authors.forename: Jin
authors.initials: J
authors.lastname: Xu
authors.affiliation: Merck & Co, Inc, Kenilworth, New Jersey; and.
authors.forename: Guanghan
authors.initials: G
authors.lastname: Liu
authors.affiliation: Merck & Co, Inc, Kenilworth, New Jersey; and.
authors.forename: Jon E
authors.initials: JE
authors.lastname: Stek
authors.affiliation: Sanofi Pasteur, Swiftwater, Pennsylvania.
authors.forename: Ginamarie
authors.initials: G
authors.lastname: Foglia
authors.affiliation: Merck & Co, Inc, Kenilworth, New Jersey; and andrew_wen-tseng_lee@merck.com.
authors.forename: Andrew W
authors.initials: AW
authors.lastname: Lee
mesh_terms: D000917:Antibody Formation; D015721:Diphtheria-Tetanus-Pertussis Vaccine / Q000009:adverse effects / Q000276:immunology*; D005260:Female; D018073:Haemophilus Vaccines / Q000009:adverse effects / Q000276:immunology*; D017325:Hepatitis B Vaccines / Q000009:adverse effects / Q000276:immunology*; D006801:Humans; D007223:Infant; D008297:Male; D011054:Poliovirus Vaccine, Inactivated / Q000009:adverse effects / Q000276:immunology*; D018074:Vaccines, Conjugate / Q000009:adverse effects / Q000276:immunology
chemical_list: D015721:Diphtheria-Tetanus-Pertussis Vaccine; D018073:Haemophilus Vaccines; D017325:Hepatitis B Vaccines; D011054:Poliovirus Vaccine, Inactivated; D018074:Vaccines, Conjugate; C541234:diphtheria-tetanus-five component acellular pertussis-inactivated poliomyelitis -Haemophilus influenzae type b conjugate vaccine