title: Immunogenicity and reactogenicity of a combined fully liquid DTPw-HepB-Hib pentavalent vaccine in healthy infants: no clinically relevant impact of a birth dose of hepatitis B vaccine.
abstract: OBJECTIVE
  In this open-label, non-randomized phase II study, the safety and immunogenicity of a fully liquid diphtheria-tetanus-whole cell pertussis-hepatitis B-Haemophilus influenzae type b (DTPw-HepB-Hib) combination vaccine (Quinvaxem(®)) were assessed in infants who had or had not received a birth dose of hepatitis B (HepB) vaccine.
  
  
  METHODS
  Two groups of infants, 'HepB at birth' (n=110) and 'no HepB at birth' (n=108), were enrolled and received a primary vaccination course using a 2-4-6 months schedule.
  
  
  RESULTS
  Seroprotection/seroconversion rates of >95% were achieved against all antigens included in the combination vaccine for both study groups. Although significantly higher anti-hepatitis B virus (p<0.001) and anti-tetanus (p=0.031) antibody titers were achieved in group 'HepB at birth' when compared with group 'no HepB at birth', the proportion of 'no HepB at birth' subjects achieving protective titers was non-inferior to the proportion of subjects in group 'HepB at birth'. The birth dose of HepB vaccine did not seem to influence the safety pattern of the DTPw-HepB-Hib combination vaccine.
  
  
  CONCLUSIONS
  The present study demonstrated that the fully liquid DTPw-HepB-Hib vaccine was safe and immunogenic when administered using a 2-4-6 months immunization schedule, regardless of whether or not infants had received a dose of HepB vaccine at birth.
authors.affiliation: Hospital de Niños Ricardo Gutierrez, Epidemiología, Buenos Aires, Argentina.
authors.forename: Angela
authors.initials: A
authors.lastname: Gentile
authors.forename: Veronica
authors.initials: V
authors.lastname: Umido
authors.forename: Paola
authors.initials: P
authors.lastname: Czerniuk
authors.forename: Josefina
authors.initials: J
authors.lastname: Nacul
authors.forename: Mauricio
authors.initials: M
authors.lastname: Seigelchifer
authors.forename: Anne Katrin
authors.initials: AK
authors.lastname: Hilbert
authors.forename: Ursula
authors.initials: U
authors.lastname: Yela
authors.forename: Christian
authors.initials: C
authors.lastname: Herzog
authors.forename: Ursula
authors.initials: U
authors.lastname: Aeberhard
authors.forename: Christian
authors.initials: C
authors.lastname: Spyr
mesh_terms: D000284:Administration, Oral; D000907:Antibodies, Bacterial / Q000097:blood*; D001886:Bordetella pertussis / Q000276:immunology; D003353:Corynebacterium diphtheriae / Q000276:immunology; D004167:Diphtheria Toxin / Q000276:immunology; D015721:Diphtheria-Tetanus-Pertussis Vaccine / Q000008:administration & dosage* / Q000009:adverse effects / Q000276:immunology*; D018073:Haemophilus Vaccines / Q000008:administration & dosage* / Q000009:adverse effects / Q000276:immunology*; D006510:Hepatitis B Antibodies / Q000097:blood; D017325:Hepatitis B Vaccines / Q000008:administration & dosage* / Q000009:adverse effects / Q000276:immunology*; D006801:Humans; D007115:Immunization Schedule; D007223:Infant; D007231:Infant, Newborn; D013744:Tetanus Toxin / Q000276:immunology; D014611:Vaccination
chemical_list: D000907:Antibodies, Bacterial; D004167:Diphtheria Toxin; D015721:Diphtheria-Tetanus-Pertussis Vaccine; C524361:DtwP-HepB-Hib vaccine; D018073:Haemophilus Vaccines; D006510:Hepatitis B Antibodies; D017325:Hepatitis B Vaccines; D013744:Tetanus Toxin