TY - JOUR
TI - Immunization of preterm infants with 10-valent pneumococcal conjugate vaccine
AU - Omeñaca, F.
AU - Merino, J.M.
AU - Tejedor, J.-C.
AU - Constantopoulos, A.
AU - Papaevangelou, V.
AU - Kafetzis, D.
AU - Tsirka, A.
AU - Athanassiadou, F.
AU - Anagnostakou, M.
AU - François, N.
AU - Borys, D.
AU - Schuerman, L.
JO - PEDIATRIC INVESTIGATION
PY - 2011
VL - 128
TODO - 2
SP - e290-e298
PB - 
SN - null
TODO - 10.1542/peds.2010-1184
TODO - bacterium antibody;  diphtheria pertussis tetanus vaccine;  Pneumococcus vaccine, anorexia;  antibody blood level;  antibody titer;  application site erythema;  application site pain;  application site swelling;  article;  child;  combination chemotherapy;  controlled study;  dose response;  drowsiness;  drug dose comparison;  drug efficacy;  drug fever;  drug safety;  drug tolerability;  female;  gestation period;  human;  immunization;  immunogenicity;  infant;  irritability;  major clinical study;  male;  outcome assessment;  pneumococcal infection;  prematurity;  preschool child;  priority journal;  serotype;  side effect, Female;  Humans;  Immunization, Secondary;  Infant;  Infant, Newborn;  Infant, Premature;  Male;  Pneumococcal Infections;  Pneumococcal Vaccines;  Vaccination;  Vaccines, Conjugate
TODO - 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. Copyright © 2011 by the American Academy of Pediatrics.
ER -