13 价肺炎球菌结合疫苗在既往接种过 7 价肺炎球菌结合疫苗或未接种过 7 价肺炎球菌结合疫苗的大龄儿童和青少年中的应用。

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

机构信息

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.

出版信息

Pediatr Infect Dis J. 2014 Feb;33(2):183-9. doi: 10.1097/INF.0000000000000056.

DOI:10.1097/INF.0000000000000056

PMID:24136369

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.

摘要

背景

13 价肺炎球菌结合疫苗（PCV13）已被证明对 <5 岁的婴儿和儿童具有免疫原性和安全性。PCV13 最近被批准用于 17 岁以下的儿童和青少年，因为这种疫苗对该年龄段的某些人可能有益。

方法

在这项开放性研究中，先前已接种过 7 价肺炎球菌结合疫苗（PCV7）的 ≥5 岁至 <10 岁（即年龄较小组）的健康儿童和未接种过肺炎球菌疫苗的 ≥10 岁至 <18 岁（即年龄较大组）的儿童接受了 1 剂 PCV13。对于年龄较小组，接种后 1 个月的肺炎球菌免疫球蛋白（Ig）G 几何平均浓度与历史对照研究中婴儿后期剂量（PCV13 或 PCV7）的水平进行了比较。年龄较大组接种后 1 个月的调理吞噬活性几何平均滴度与年龄较小组进行了比较。收集了安全性数据。

结果

共有 598 名儿童入组，每组 299 名。对于 PCV7 血清型，年龄较小组的 IgG 几何平均浓度为 8.23-53.56 μg/mL，比历史婴儿后期剂量值高 2.5 倍以上。对于另外 6 种血清型，年龄较小组的 IgG 几何平均浓度为 2.38-21.51 μg/mL，比历史婴儿后期剂量值高 1.2 倍以上。年龄较大组和年龄较小组的调理吞噬活性几何平均滴度相似，除 3 型血清型外，年龄较大组的滴度较低。两组的安全性相似。