在台湾，与常规儿科疫苗联合使用的 13 价肺炎球菌结合疫苗的免疫原性和安全性。
Immunogenicity and safety of a 13-valent pneumococcal conjugate vaccine given with routine pediatric vaccines in Taiwan.
机构信息
Department of Pediatrics, National Taiwan University Hospital, Taipei, Taiwan.
出版信息
Vaccine. 2012 Mar 9;30(12):2054-9. doi: 10.1016/j.vaccine.2011.12.054. Epub 2011 Dec 22.
UNLABELLED
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 μg/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.
未标注
在台湾儿童中比较了 13 价和 7 价肺炎球菌结合疫苗（PCV13；PCV7）的免疫原性和安全性。在这项双盲、多中心研究中，健康儿童随机分配在 2、4、6 和 15 个月时接受 PCV13（n=84）或 PCV7（n=84），同时接种常规儿科疫苗。对于 7 种 PCV13/PCV7 共有血清型，血清型特异性免疫球蛋白 G（IgG）几何平均浓度（GMC）在婴儿系列接种后 1 个月较高，两组均有≥95.0%的个体 IgG 水平≥0.35μg/mL，PCV13 的 IgG GMC 趋势低于 PCV7（PCV13:PCV7 GMC 比值为 0.59-0.91）。对于 PCV13 特有的另外 6 种血清型，PCV13 后的 GMC 明显高于 PCV7（PCV13:PCV7 GMC 比值为 1.50-202.58）。免疫反应在幼儿剂量后通常增加。两组间安全性相似。PCV13 在台湾人群中是安全且具有免疫原性的。PCV13 应该比 PCV7 提供更广泛的针对肺炎球菌疾病的保护。
临床试验注册号
NCT00688870。
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