13价肺炎球菌结合疫苗对先前接种过23价肺炎球菌多糖疫苗的老年人的安全性:一项开放标签试验

T. Schwarz, K. Pauksens, C. Juergens, D. Jayawardene, D. Scott, W. Gruber, B. Schmoele-Thoma
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引用次数: 8

摘要

为了描述13价肺炎球菌结合疫苗(PCV13)在1049例年龄≥68岁的人群中的安全性,进行了一项开放标签、多中心的研究,这些人群之前接种过未结合的23价肺炎球菌多糖疫苗(PPSV23)。此外,在一项事后描述性分析中,将本研究中PCV13的安全性与在其他已完成的研究中接受PCV13或PPSV23的老年人群中观察到的安全性进行了比较。局部反应(56.6%)和全身反应(58.4%)非常常见,但主要是轻微的,持续时间短(平均:1.3 - 4.6天)。PCV13术后1个月内无相关严重不良事件(ae)。在接种PCV13疫苗后123天和接种非研究流感疫苗后94天,发生了一例短暂的格林-巴利综合征,研究者认为这可能与接种疫苗有关。在本研究人群中观察到的反应原性与ppsv23 -预免疫成人和ppsv23 -初发成人的其他老年研究人群大致相似。在本研究中,反应原性比在PPSV23-预免疫的成年人中观察到的更少,这些成年人再次接种PPSV23而不是随后的PCV13剂量。在这些比较研究中,未见PCV13和PPSV23发生相关严重不良事件的报道。结论:既往接种过PPSV23疫苗的老年人可安全接种PCV13疫苗。(临床试验。gov标识符:NCT00500266)
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Safety of a 13-Valent Pneumococcal Conjugate Vaccine in Elderly Adults Previously Immunized with a 23-Valent Pneumococcal Polysaccharide Vaccine: An Open-Label Trial
An open-label, multicenter study was conducted to describe the safety of the 13-valent pneumococcal conjugate vaccine (PCV13) in 1049 individuals aged ≥68 years, who had previously been immunized with the unconjugated 23-valent pneumococcal polysaccharide vaccine (PPSV23). In addition, the safety profile of PCV13 in this study was compared, in a post-hoc descriptive analysis, to that observed in other elderly populations, who had received PCV13 or PPSV23 as part of other completed studies. Local (56.6%) and systemic reactions (58.4%) were very common, but were mainly mild, and of short duration (mean: 1.3 - 4.6 days). There were no related serious adverse events (AEs) within 1 month after PCV13. 123 days after PCV13 and 94 days after a nonstudy influenza vaccine, a case of transient Guillain-Barre syndrome occurred, which the investigator assessed as possibly related to the vaccination. Reactogenicity observed in this study population was generally similar to that of other elderly study populations with PPSV23-preimmunized adults, and with PPSV23-naive adults. Reactogenicity was less common in this study than that observed in PPSV23-preimmunized adults who were revaccinated with PPSV23 rather than a subsequent dose of PCV13. There were no related serious AEs reported after PCV13 and PPSV23 in these comparator studies. Conclusion: PCV13 may be administered safely to older adults previously immunized with PPSV23. (ClinicalTrials. gov Identifier: NCT00500266)
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