Immunogenicity and safety of a 13-valent pneumococcal conjugate vaccine given with routine pediatric vaccines in Taiwan

被引：15

作者：

Huang, Li-Min ^{[3
]}

Lin, Tzou-Yien ^{[1
]}

Juergens, Christine ^{[2
]}

机构：

[1] Chang Gung Univ, Coll Med, Chang Gung Childrens Hosp, Dept Pediat, Tao Yuan, Taiwan

[2] Pfizer Pharma GmbH, Berlin, Germany

[3] Natl Taiwan Univ Hosp, Dept Pediat, Taipei 10016, Taiwan

来源：

VACCINE | 2012年 / 30卷 / 12期

关键词：

PCV13; PCV7; Streptococcus pneumoniae; Immunogenicity; Safety; ANTIMICROBIAL RESISTANCE PATTERNS; CHILDREN; SEROTYPES; EFFICACY; INFANTS;

D O I：

10.1016/j.vaccine.2011.12.054

中图分类号：

R392 [医学免疫学]; Q939.91 [免疫学];

学科分类号：

100102 ;

摘要：

Immunogenicity and safety of 13-valent and 7-valent pneumococcal conjugate vaccines (PCV13; PCV7) were compared in Taiwanese children. In this double-blind, multicenter study, healthy children were randomly assigned to receive PCV13 (n = 84) or PCV7 (n = 84) at 2, 4, 6 and 15 months with routine pediatric vaccines. For the 7 PCV13/PCV7 common serotypes, serotype-specific immunoglobulin G (IgG) geometric mean concentrations (GMCs) were high 1 month postinfant series, with >= 95.0% in both groups achieving IgG levels >= 0.35 mu g/mL, with a trend to lower IgG GMCs for PCV13 compared with PCV7 (PCV13:PCV7 GMC ratios 0.59-0.91). For the 6 additional serotypes unique to PCV13, GMCs were notably higher after PCV13 than PCV7 (PCV13:PCV7 GMC ratios 1.50-202.58). Immune responses generally increased posttoddler dose. Safety was similar between groups. PCV13 was safe and immunogenic in this Taiwanese population. PCV13 should offer broader protection than PCV7 against pneumococcal disease. Clinical trials registration number: NCT00688870 (C) 2012 Elsevier Ltd. All rights reserved.

引用

页码：2054 / 2059

页数：6

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