RT Journal Article
T1 13-Valent Pneumococcal Conjugate Vaccine (PCV13) in Preterm Versus Term Infants
A1 Martinón Torres, Federico
A1 Concheiro Guisán, Ana
A1 Gurtman, Alejandra
K1 Immunization
K1 Immunogenicity
K1 Pneumococcal conjugate vaccine
K1 Preterm infants
K1 Safety
AB Objectives: This study evaluated the immune response and safety profile of 13-valent pneumococcal conjugate vaccine (PCV13) in preterm infants compared with term infants.Methods: This Phase IV, open-label, 2-arm, multicenter, parallel-group study enrolled 200 healthy infants (preterm, n = 100; term, n = 100) aged 42 to 98 days. All subjects received PCV13 at ages 2, 3, 4 (infant series), and 12 (toddler dose [TD]) months, together with routine vaccines (diphtheria-tetanus-acellular pertussis, hepatitis B, inactivated poliovirus, and Haemophilus influenzae type b vaccine and meningococcal group C conjugate vaccine).Results: Most subjects achieved an anticapsular immunoglobulin G (IgG) antibody concentration ≥ 0.35 μg/mL for all serotypes: >85% after the infant series (except preterm infants for serotypes 5, 6A, and 6B) and >97% after TD (except for serotype 3). Preterm infants had overall lower IgG geometric mean concentrations compared with term infants; however, geometric mean fold increases after TD were similar for all serotypes. Opsonophagocytic activity results were consistent with IgG results and titers increased after TD in both groups for all serotypes, including serotype 3. PCV13 was generally well tolerated, with similar safety profiles in all preterm subgroups.Conclusions: Immune responses were lower in preterm infants than in term infants. However, the majority of subjects in both groups achieved both pneumococcal serotype-specific IgG antibody levels after the infant series that exceeded the World Health Organization-established threshold of protection and functional antibody responses. Responses were uniformly higher after TD, reinforcing the importance of a timely booster dose. PCV13 was well tolerated regardless of gestational age.
PB Elsevier
YR 2015
FD 2015-04-01
LK https://hdl.handle.net/10347/38669
UL https://hdl.handle.net/10347/38669
LA eng
NO Martinón-Torres F, Czajka H, Center KJ, Wysocki J, Majda-Stanislawska E, Omeñaca F, Bernaola Iturbe E, Blazquez Gamero D, Concheiro-Guisán A, Gimenez-Sanchez F, Szenborn L, Giardina PC, Patterson S, Gruber WC, Scott DA, Gurtman A. 13-valent pneumococcal conjugate vaccine (PCV13) in preterm versus term infants. Pediatrics. 2015 Apr;135(4):e876-86. doi: 10.1542/peds.2014-2941
NO ClinicalTrials.gov NCT01193335
DS Minerva
RD 4 may 2026