title: Comparison of the immunogenicity and safety of pentavalent vaccine Quinvaxem in a compact prefilled auto-disabled (cPAD) injection system versus single-dose vials in healthy infants: a phase 3, open-label, randomized, parallel-group, non-inferiority study.
abstract: OBJECTIVE
  To evaluate non-inferiority of three doses of Quinvaxem in a compact prefilled auto-disabled (cPAD) injection system versus Quinvaxem in a single-dose vial administered with conventional syringe in terms of seroconversion/seroprotection rates for all antibodies (anti-hepatitis B (HB), anti-Haemophilus influenzae type b polyribosylribitol phosphate (Hib PRP), anti-diphtheria, anti-tetanus, anti-Bordetella pertussis) at 1 month after primary vaccination.
  
  
  METHODS
  Four hundred healthy infants aged 42-65 days were randomized (1:1) to receive Quinvaxem in cPAD or single-dose vial at 6, 10, and 12 weeks of age. Blood samples were collected before vaccination and at 1 month after the third dose to determine seroconversion/seroprotection rates. Safety was assessed from solicited and unsolicited adverse events and serious adverse events (SAEs).
  
  
  RESULTS
  Of the 400 infants randomized, 395 (98.8%) received all three vaccine doses. In the cPAD vs. single-dose vial groups, seroprotection rates against Hib PRP (both 98.5%), HB (92.9% vs. 93.4%), diphtheria (100% vs. 99%), and tetanus toxoids (both 100%), and seroconversion against B. pertussis (95.4% vs. 97%) were ≥92% at 1 month after the third vaccination (lower limits of 95% confidence intervals simultaneously greater than -10%). Geometric mean concentrations exceeded seroprotection/seroconversion thresholds by large margins. The incidences of induration and erythema were comparable between the groups; tenderness was slightly higher in the cPAD group (85.5% vs. 76.5%). No vaccine-related SAEs occurred.
  
  
  CONCLUSIONS
  Quinvaxem in cPAD was non-inferior to single-dose vial with respect to seroprotection/seroconversion rates for all antibodies. Both presentations were well-tolerated.
authors.affiliation: Research Institute for Tropical Medicine, 9002 Research Drive, Filinvest Corporate City, Alabang, Muntinlupa City 1781, Philippines. Electronic address: lerosecap@gmail.com.
authors.forename: Maria Rosario Z
authors.initials: MR
authors.lastname: Capeding
authors.affiliation: Research Institute for Tropical Medicine, 9002 Research Drive, Filinvest Corporate City, Alabang, Muntinlupa City 1781, Philippines.
authors.forename: Edison
authors.initials: E
authors.lastname: Alberto
authors.affiliation: Crucell Holland BV, Leiden, Netherlands.
authors.forename: Amanda
authors.initials: A
authors.lastname: Versteilen
authors.affiliation: Crucell Switzerland AG, Bern, Switzerland.
authors.forename: Martina
authors.initials: M
authors.lastname: Rauscher
authors.affiliation: Janssen Research and Development, Raritan, New Jersey, USA.
authors.forename: Partha
authors.initials: P
authors.lastname: Bagchi
authors.affiliation: Crucell Switzerland AG, Bern, Switzerland.
authors.forename: Patricia Ibarra de
authors.initials: PI
authors.lastname: Palacios
mesh_terms: D004165:Diphtheria / Q000276:immunology / Q000517:prevention & control*; D015721:Diphtheria-Tetanus-Pertussis Vaccine / Q000008:administration & dosage / Q000276:immunology*; D005260:Female; D006192:Haemophilus Infections / Q000276:immunology / Q000517:prevention & control*; D018073:Haemophilus Vaccines / Q000008:administration & dosage / Q000276:immunology*; D006509:Hepatitis B / Q000276:immunology / Q000517:prevention & control*; D017325:Hepatitis B Vaccines / Q000008:administration & dosage / Q000276:immunology*; D006801:Humans; D007223:Infant; D008297:Male; D013742:Tetanus / Q000276:immunology / Q000517:prevention & control*; D014611:Vaccination / Q000295:instrumentation / Q000379:methods; D017778:Vaccines, Combined / Q000008:administration & dosage / Q000276:immunology; D018074:Vaccines, Conjugate / Q000008:administration & dosage / Q000276:immunology; D014917:Whooping Cough / Q000276:immunology / Q000517:prevention & control*
chemical_list: D015721:Diphtheria-Tetanus-Pertussis Vaccine; D018073:Haemophilus Vaccines; D017325:Hepatitis B Vaccines; D017778:Vaccines, Combined; D018074:Vaccines, Conjugate
keywords: Compact prefilled auto-disabled injection; Immunogenicity; Pentavalent vaccine; Quinvaxem; Single-dose vials