title: Immunogenicity and safety in infants of a DTwPHib full liquid vaccine.
abstract: OBJECTIVE
  Combining paediatric vaccines is a rational solution to reduce the number of injections during a single clinical visit, to maintain parents' compliance and to extend vaccine coverage. Different diphtheria, tetanus and whole cell pertussis (DTwP)-containing combination vaccines are licensed and used world-wide. This study assessed the immunogenicity and safety in infants of a combined diphtheria-tetanus-whole cell pertussis-Haemophilus influenzae type b-CRM197 conjugate full liquid vaccine.
  
  
  METHODS
  The safety and efficacy of a combined ready-to-use liquid vaccine containing diphtheria and tetanus toxoids, cell suspension of Bordetella pertussis and H. influenzae type b-CRM197 conjugate vaccine (DTwPHib) were assessed in infants eligible for the local Expanded Programme on Immunization (EPI) in Valencia, Spain. The comparative group received separate injections of reference vaccines DTwP + Hib.
  
  
  RESULTS
  Local and systemic reactions and adverse events were generally mild and similar in the two groups. DTwPHib elicited anti-PRP antibody titres > or = 0.15 microg ml(-1) in 97% and DTwP + Hib in 94% of infants. Furthermore, 89% of DTwPHib and 78% of DTwP + Hib recipients attained anti-PRP antibody titres > or = 1.0 microg ml(-1), signifying long-term protection. The anti-PRP geometric mean titre was significantly higher in the combined DTwPHib vaccine group (6.65 vs 3.57 microg ml(-1)). In both groups, 99% of infants achieved protective (> or = 0.01 IU ml(-1)) anti-diphtheria antibody levels and all children achieved protective (> or = 0.1 IU ml(-1)) anti-tetanus antibody levels. DTwPHib caused a > or = 2-fold increase in anti-pertactin antibody titres in 91% and a > or = 4-fold increase in 82% of recipients. The corresponding proportions in the DTwP + Hib group were 95% and 90%. DTwPHib induced a > or = 2-fold increase in anti-Aggl2 and 3 antibody levels in 79% and a > or = 4-fold increase in 73% of recipients. The corresponding proportions among DTwP + Hib infants were 85 and 82%.
  
  
  CONCLUSIONS
  Overall, the combined liquid vaccine DTwPHib is a safe and effective immunogenic vaccine for EPI use in infants.
authors.affiliation: Departamento de Enfermedades Infecciosas, Hospital Infantil-Hospital Universitario La Fé, Valencia, Spain.
authors.forename: F I
authors.initials: FI
authors.lastname: Botet Asensi
authors.forename: A
authors.initials: A
authors.lastname: Veronese
authors.forename: M
authors.initials: M
authors.lastname: Del Carmen Otero
authors.forename: M
authors.initials: M
authors.lastname: Desamparados Tamarit Pérez
authors.forename: J L
authors.initials: JL
authors.lastname: Hontangas Lopez
authors.forename: S
authors.initials: S
authors.lastname: Viviani
mesh_terms: D000906:Antibodies / Q000097:blood / Q000187:drug effects; D016667:Bacterial Capsules; D015721:Diphtheria-Tetanus-Pertussis Vaccine / Q000008:administration & dosage / Q000009:adverse effects* / Q000276:immunology*; D004334:Drug Administration Schedule; D004347:Drug Interactions; D005500:Follow-Up Studies; D018073:Haemophilus Vaccines / Q000008:administration & dosage / Q000009:adverse effects* / Q000276:immunology*; D006801:Humans; D007109:Immunity / Q000187:drug effects*; D007115:Immunization Schedule; D007125:Immunogenetics; D007223:Infant; D011135:Polysaccharides, Bacterial / Q000008:administration & dosage / Q000009:adverse effects* / Q000276:immunology*; D013997:Time Factors; D017778:Vaccines, Combined
chemical_list: D000906:Antibodies; D015721:Diphtheria-Tetanus-Pertussis Vaccine; D018073:Haemophilus Vaccines; C044237:Haemophilus influenzae type b polysaccharide vaccine; D011135:Polysaccharides, Bacterial; D017778:Vaccines, Combined