Northwest Arkansas Pediatrics, Fayetteville, AR 72703-4815, USA.
Pediatr Infect Dis J. 2013 Aug;32(8):871-80. doi: 10.1097/INF.0b013e3182906499.
The 7-valent pneumococcal conjugate vaccine (PCV7; serotypes 4, 6B, 9V, 14, 18C, 19F and 23F) has decreased invasive pneumococcal disease incidence. This study was performed to support licensure of a 13-valent pneumococcal conjugate vaccine (PCV13), which expands serotype coverage to include serotypes 1, 3, 5, 6A, 7F and 19A. This study assessed the immunogenicity, safety and manufacturing consistency of PCV13.
Randomized, double-blind, multicenter trial. Healthy United States infants were randomized 2:2:2:1 to receive 1 of 3 lots of PCV13 or PCV7, along with routine US pediatric vaccines at ages 2, 4 and 6 months (infant series), and 12 months (toddler dose).
Among 1709 vaccinated infants, 1 month postinfant series and 1 month posttoddler dose, immunoglobulin G geometric mean concentrations (GMCs) were within 2-fold among the PCV13 lots, meeting equivalence criteria for all 13 serotypes. In a post hoc analysis, based on percent responders at ≥0.35 μg/mL postinfant series and immunoglobulin G GMC ratios postinfant series and posttoddler dose, noninferiority criteria were met for combined PCV13 lots compared with PCV7 for all common serotypes. Posttoddler dose immunoglobulin G GMCs were higher than postinfant series GMCs for all serotypes. Local reactions and fevers were generally mild; incidences of local reactions, systemic events and adverse events were generally similar between groups.
PCV13 can be manufactured in a manner that elicits consistent immune responses. PCV13 provides increased serotype coverage and immunogenicity that is noninferior to PCV7 and has a safety profile similar to PCV7 when given with routine pediatric vaccines.
7 价肺炎球菌结合疫苗（PCV7；血清型 4、6B、9V、14、18C、19F 和 23F）已降低侵袭性肺炎球菌病的发病率。本研究旨在支持 13 价肺炎球菌结合疫苗（PCV13）的许可，该疫苗扩大了血清型覆盖范围，包括血清型 1、3、5、6A、7F 和 19A。本研究评估了 PCV13 的免疫原性、安全性和制造一致性。
随机、双盲、多中心试验。健康的美国婴儿以 2:2:2:1 的比例随机接受 3 种 PCV13 或 PCV7 中的 1 种，以及美国儿科常规疫苗，在 2、4 和 6 个月（婴儿系列）和 12 个月（幼儿剂量）时接种。
在 1709 名接种疫苗的婴儿中，在婴儿系列接种后 1 个月和幼儿剂量接种后 1 个月，PCV13 批次之间的免疫球蛋白 G 几何平均浓度（GMC）在 2 倍以内，符合所有 13 种血清型的等效标准。在事后分析中，根据婴儿系列后≥0.35μg/ml的百分比应答者和婴儿系列后和幼儿剂量后的免疫球蛋白 G GMC 比值，与 PCV7 相比，所有常见血清型的组合 PCV13 批次均符合非劣效性标准。幼儿剂量的免疫球蛋白 G GMC 高于所有血清型的婴儿系列 GMC。局部反应和发热通常较轻；各组之间的局部反应、全身事件和不良事件的发生率通常相似。
PCV13 可以以产生一致免疫反应的方式制造。PCV13 提供了更高的血清型覆盖率和免疫原性，与 PCV7 相比具有非劣效性，并且与常规儿科疫苗联合使用时具有与 PCV7 相似的安全性。
