ABSTRACT

Introduction: Evidence on the interchangeability between the two pediatric pneumococcal conjugate vaccines (PCVs) – pneumococcal non-typeable Haemophilus influenzae protein D-conjugate vaccine (PHiD-CV) and 13-valent PCV (PCV13) – is limited but growing. We performed a systematic literature review to summarize evidence for PHiD-CV/PCV13 interchangeability regarding immunogenicity, safety, and effectiveness against pneumococcal disease.

Areas covered: Seven records disclosing results from six studies on PHiD-CV/PCV13 interchangeability were identified. Four clinical trials showed that mixed schedules with a PHiD-CV-to-PCV13 switch at boosting or a PCV13-to-PHiD-CV switch during priming or at boosting were immunogenic with no apparent safety concerns. Two observational studies in the context of a programmatic PHiD-CV-to-PCV13 switch showed similarly high effectiveness against overall invasive pneumococcal disease with a mixed PHiD-CV/PCV13 schedule and a PCV13-only schedule. No effectiveness data for a PCV13-to-PHiD-CV switch and no immunogenicity/safety/effectiveness data for a PHiD-CV-to-PCV13 switch during priming were found.

Expert opinion: For epidemiological or programmatic reasons, several local/national authorities have switched PCVs in their immunization programs. Consequently, children have received mixed schedules. Although herd immunity may obscure the individual effect, the limited data are reassuring. Additional evidence from these settings – especially effectiveness or impact data – may provide the necessary information for authorities to make informed decisions on interchanging PCVs.

摘要

简介：关于两种儿童肺炎球菌结合疫苗（PCV）–肺炎球菌不可分型流感嗜血杆菌D结合疫苗（PHiD-CV）和13价PCV（PCV13）之间互换性的证据有限，但仍在增长。我们进行了系统的文献综述，以总结关于PHiD-CV / PCV13可互换性的证据，涉及免疫原性，安全性和抗肺炎球菌疾病的有效性。

涵盖领域：确定了七项记录，这些记录公开了六项关于PHiD-CV / PCV13互换性的研究结果。四个临床试验表明，在初免期间或初免时，在升压时使用PHiD-CV到PCV13开关或在升压时将PCV13到PHiD-CV开关的混合时间表具有免疫原性，没有明显的安全隐患。在程序性PHiD-CV到PCV13转换的背景下进行的两项观察性研究显示，在混合PHiD-CV / PCV13计划和仅PCV13计划的情况下，针对总体浸润性肺炎球菌疾病具有相似的高有效性。在启动过程中，没有发现PCV13到PHiD-CV开关的有效性数据，也没有发现PHiD-CV到PCV13开关的免疫原性/安全性/有效性数据。

专家意见：出于流行病学或计划的原因，一些地方/国家主管部门已将PCV转换为其免疫计划。因此，孩子们收到了不同的时间表。尽管畜群免疫力可能会掩盖个体效应，但有限的数据令人放心。这些设置提供的其他证据，尤其是有效性或影响数据，可能会为当局提供必要的信息，以便他们就互换PCV做出明智的决定。