Safety of a 4-Dose 20-Valent Pneumococcal Conjugate Vaccine Series in Infants: A Randomized Trial.

IF 6.2 2区 医学 Q1 PEDIATRICS Pediatrics Pub Date : 2024-11-01 DOI:10.1542/peds.2023-065218
Gabriella Hajdu, Teena Hughes, G Laïssa Ouedraogo, Laurence Flint, Mariano Young, Vrunda Parikh, Dung-Yang Lee, Yahong Peng, William C Gruber, Daniel A Scott, Wendy Watson
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Abstract

Background and objectives: The 20-valent pneumococcal conjugate vaccine (PCV20) was developed to expand protection for pneumococcal disease. It contains all 13-valent pneumococcal conjugate vaccine (PCV13) components plus conjugates for 7 additional serotypes. Our primary objective with this study was to evaluate PCV20 tolerability and safety.

Methods: In this phase 3, multi-country, double-blind study, healthy infants born at ≥34 weeks' gestation were randomly assigned 2:1 to receive PCV20 or PCV13 at 2, 4, 6, and 12 to 15 months of age. Safety assessments included local reactions and systemic events within 7 days after each vaccination, adverse events (AEs) from dose 1 to 1 month after dose 3 and from dose 4 to 1 month after dose 4, and serious AEs and newly diagnosed chronic medical conditions from dose 1 through 6 months after the last dose.

Results: Participants received PCV20 (N = 1000) or PCV13 (N = 504); 91.7% received all 4 doses. The frequencies of local reactions and systemic events were generally similar in PCV20 and PCV13 groups, with most reported as mild or moderate. The most common local reaction was injection site pain (PCV20, 24.7% to 40.5%; PCV13, 26.8% to 42.0%); irritability was the most common systemic event (PCV20, 54.8% to 68.2%; PCV13, 54.7% to 68.5%). AE frequencies were similar in both groups. No serious AEs were related to study vaccines. Few newly diagnosed chronic medical conditions were reported (2.8% in both groups). PCV20 was safe across multiple countries, in late preterm infants, and when administered with other vaccines.

Conclusions: A 4-dose series of PCV20 had a tolerability and safety profile similar to that of PCV13.

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婴儿接种 4 剂 20 价肺炎球菌结合疫苗系列的安全性:随机试验
背景和目的:20 价肺炎球菌结合疫苗 (PCV20) 的开发旨在扩大对肺炎球菌疾病的保护范围。它包含 13 价肺炎球菌结合疫苗 (PCV13) 的所有成分以及另外 7 种血清型的结合疫苗。这项研究的主要目的是评估 PCV20 的耐受性和安全性:在这项3期多国双盲研究中,妊娠期≥34周的健康婴儿被2:1随机分配,分别在2、4、6和12至15个月大时接种PCV20或PCV13。安全性评估包括每次接种后7天内的局部反应和全身事件、第1剂至第3剂后1个月、第4剂至第4剂后1个月的不良事件(AE),以及第1剂至最后一剂后6个月的严重AE和新诊断的慢性疾病:参与者接种了 PCV20(1000 人)或 PCV13(504 人);91.7% 的参与者接种了全部 4 剂。PCV20 组和 PCV13 组发生局部反应和全身事件的频率基本相似,大多数反应为轻度或中度。最常见的局部反应是注射部位疼痛(PCV20,24.7% 至 40.5%;PCV13,26.8% 至 42.0%);烦躁是最常见的全身反应(PCV20,54.8% 至 68.2%;PCV13,54.7% 至 68.5%)。两组的 AE 发生率相似。没有出现与研究疫苗相关的严重不良反应。新诊断的慢性疾病报告很少(两组均为 2.8%)。PCV20在多个国家、晚期早产儿以及与其他疫苗同时接种时都是安全的:PCV20 4剂系列的耐受性和安全性与PCV13相似。
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来源期刊
Pediatrics
Pediatrics 医学-小儿科
CiteScore
12.80
自引率
5.00%
发文量
791
审稿时长
2-3 weeks
期刊介绍: The Pediatrics® journal is the official flagship journal of the American Academy of Pediatrics (AAP). It is widely cited in the field of pediatric medicine and is recognized as the leading journal in the field. The journal publishes original research and evidence-based articles, which provide authoritative information to help readers stay up-to-date with the latest developments in pediatric medicine. The content is peer-reviewed and undergoes rigorous evaluation to ensure its quality and reliability. Pediatrics also serves as a valuable resource for conducting new research studies and supporting education and training activities in the field of pediatrics. It aims to enhance the quality of pediatric outpatient and inpatient care by disseminating valuable knowledge and insights. As of 2023, Pediatrics has an impressive Journal Impact Factor (IF) Score of 8.0. The IF is a measure of a journal's influence and importance in the scientific community, with higher scores indicating a greater impact. This score reflects the significance and reach of the research published in Pediatrics, further establishing its prominence in the field of pediatric medicine.
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