13-valent Pneumococcal Conjugate Vaccine in Older Children and Adolescents Either Previously Immunized With or Naive to 7-valent Pneumococcal Conjugate Vaccine
ABSTRACT The 13-valent pneumococcal conjugate vaccine (PCV13) has been demonstrated to be immunogenic and safe for administration to infants and children aged <5 years. PCV13 recently was approved for children and adolescents aged up to 17 years as the vaccine may be of benefit to some in this older age group.
In this open-label study, healthy children aged ≥5 to <10 years (ie, the younger age group) previously vaccinated (≥1 dose) with 7-valent pneumococcal conjugate vaccine (PCV7) and pneumococcal vaccine-naïve children aged ≥10 to <18 years (ie, the older age group) received 1 dose of PCV13. For the younger group, antipneumococcal immunoglobulin (Ig) G geometric mean concentrations (GMCs) 1 month postvaccination were compared with posttoddler dose (PCV13 or PCV7) levels from a historical control study. Opsonophagocytic activity (OPA) geometric mean titers (GMTs) 1 month postvaccination for the older group were compared with the younger age group. Safety data were collected.
598 children were enrolled, 299 in each age group. For PCV7 serotypes, IgG GMCs in the younger group were 8.23-53.56 µg/mL, ≥2.5-fold greater than historical posttoddler dose values. For the 6 additional serotypes, IgG GMCs in the younger group were 2.38-21.51 µg/mL, ≥1.2-fold greater than historical posttoddler dose values. OPA GMTs were similar in the older and younger age groups, except for serotype 3 which was lower in the older group. Safety was comparable in both groups.
PCV13 was immunogenic and safe when administered to older children and adolescents, regardless of prior PCV7 vaccination.
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ABSTRACT: Background: Pneumococcal conjugate vaccine (PCV) antibody persistence and immunologic memory responses may be indicative of protection in previously vaccinated children. In children vaccinated in a previous study with an infant/toddler regimen of 4 doses of PCV7, 4 doses of PCV13, or 3 doses of PCV7 (infant series) and a dose of PCV13 (toddler dose), this follow-on study evaluated antibody persistence >= 24 months after the toddler dose, and immunogenicity and safety of a follow-on dose of PCV13. Methods: Children >= 3 years of age who had completed the initial study received 1 dose of PCV13 in this phase 3, open-label follow-on study in France. Serotype-specific anticapsular immunoglobulin G (IgG) and functional opsonophagocytic activity (OPA) were compared across the previous study vaccination groups, before, 4-7 days (IgG only), and 1 month after follow-on vaccination. Safety was assessed. Results: Before follow-on vaccination, IgG and OPA levels for the PCV7 serotypes were comparable across vaccination groups, but were generally higher for the 6 additional serotypes in children who received PCV13 in the previous study. At both time points after the follow-on vaccination, IgG and OPA values for all 13 serotypes increased, those for the PCV7 serotypes were similar across vaccination groups, but concentrations for the additional serotypes were higher in children who had received PCV13 in the previous study. PCV13 was well-tolerated. Conclusions: Antibody persistence and rapid responses after a follow-on dose of PCV13 suggest that even a single toddler dose of PCV13 is likely to provide protection against the 6 additional PCV13 serotypes.The Pediatric Infectious Disease Journal 08/2014; 33(10). DOI:10.1097/INF.0000000000000459 · 3.14 Impact Factor