title: Immunization of preterm infants with 10-valent pneumococcal conjugate vaccine.
abstract: OBJECTIVE
  The safety and immunogenicity of the 10-valent pneumococcal nontypeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) in preterm infants were assessed in this study.
  
  
  METHODS
  Three parallel groups of infants received 3-dose primary immunization with PHiD-CV at 2, 4, and 6 months of age and a booster dose at 16 to 18 months: preterm I (gestation period ≥ 27 and <31 weeks, N = 50); preterm II (≥31 and <37 weeks, N = 87); and term (≥37 weeks, N = 149). Solicited symptoms and adverse events were recorded. Immune responses to PHiD-CV and coadministered vaccine antigens were measured.
  
  
  RESULTS
  The incidence of solicited general symptoms was similar across groups, and the frequency of grade 3 general symptoms was low. Incidences of redness and swelling were generally lower in preterm infants. PHiD-CV was immunogenic for each of the 10 vaccine pneumococcal serotypes (postprimary, ≥92.7% of infants reached enzyme-linked immunosorbent assay antibody concentrations ≥ 0.2 μg/mL and postbooster, ≥97.6%) and for protein D, with a trend for lower postprimary geometric mean antibody concentrations and opsonophagocytic activity (OPA) titers in preterm infants for some pneumococcal serotypes. Postbooster, ≥91.9% of subjects in each group had an OPA titer ≥ 8 for each of the vaccine serotypes. Pneumococcal antibody concentrations and OPA titers after priming and booster vaccination were comparable between the 2 preterm groups.
  
  
  CONCLUSIONS
  PHiD-CV was well tolerated and immunogenic in preterm infants when given as a 3-dose primary vaccination, with robust enzyme-linked immunosorbent assay antibody and OPA booster responses in the second year of life.
authors: Neonatal Unit, La Paz Hospital, Madrid, Spain.
authors: Félix
authors: F
authors: Omeñaca
authors: Jose Manuel
authors: JM
authors: Merino
authors: Juan-Carlos
authors: JC
authors: Tejedor
authors: Andreas
authors: A
authors: Constantopoulos
authors: Vassiliki
authors: V
authors: Papaevangelou
authors: Dimitrios
authors: D
authors: Kafetzis
authors: Antigoni
authors: A
authors: Tsirka
authors: Fani
authors: F
authors: Athanassiadou
authors: Marina
authors: M
authors: Anagnostakou
authors: Nancy
authors: N
authors: François
authors: Dorota
authors: D
authors: Borys
authors: Lode
authors: L
authors: Schuerman
mesh_terms: D005260:Female; D006801:Humans; D007117:Immunization, Secondary / Q000379:methods / Q000639:trends; D007223:Infant; D007231:Infant, Newborn; D007234:Infant, Premature; D008297:Male; D011008:Pneumococcal Infections / Q000276:immunology / Q000517:prevention & control*; D022242:Pneumococcal Vaccines / Q000008:administration & dosage* / Q000276:immunology; D014611:Vaccination / Q000379:methods* / Q000639:trends; D018074:Vaccines, Conjugate / Q000008:administration & dosage / Q000276:immunology
chemical_list: C538863:10-valent pneumococcal vaccine; D022242:Pneumococcal Vaccines; D018074:Vaccines, Conjugate