Format

Send to

Choose Destination
See comment in PubMed Commons below
Pediatr Infect Dis J. 2014 Feb;33(2):183-9. doi: 10.1097/INF.0000000000000056.

13-Valent pneumococcal conjugate vaccine in older children and adolescents either previously immunized with or naïve to 7-valent pneumococcal conjugate vaccine.

Author information

1
From the *Department of Pediatrics, Cincinnati Children's Hospital Medical Center, Cincinnati, OH; †Pfizer Inc, Pearl River, NY; ‡Senders Pediatrics, Cleveland, OH; §Alpha Clinical Research, Clarksville, TN; ¶Edinger Medical Group, Fountain Valley, CA; and ‖Pfizer Inc, Collegeville, PA.

Abstract

BACKGROUND:

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.

METHODS:

In this open-label study, healthy children aged ≥5 to <10 years (ie, the younger age group) previously vaccinated (≥1 dose) with 7-valent PCV (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 1 month postvaccination were compared with posttoddler dose (PCV13 or PCV7) levels from a historical control study. Opsonophagocytic activity geometric mean titers 1 month postvaccination for the older group were compared with the younger age group. Safety data were collected.

RESULTS:

Five hundred and ninety-eight children were enrolled, 299 in each age group. For PCV7 serotypes, IgG geometric mean concentrations 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 geometric mean concentrations in the younger group were 2.38-21.51 μg/mL, ≥1.2-fold greater than historical posttoddler dose values. Opsonophagocytic activity geometric mean titers 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.

CONCLUSIONS:

PCV13 was immunogenic and safe when administered to older children and adolescents, regardless of prior PCV7 vaccination.

TRIAL REGISTRATION:

ClinicalTrials.gov NCT00761631.

PMID:
24136369
DOI:
10.1097/INF.0000000000000056
[Indexed for MEDLINE]
PubMed Commons home

PubMed Commons

0 comments
How to join PubMed Commons

    Supplemental Content

    Full text links

    Icon for Lippincott Williams & Wilkins
    Loading ...
    Support Center