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 unconjugate...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-Barré 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)展开更多
目的:探讨23价肺炎球菌多糖疫苗质量控制标准。方法:对《中国药典》三部(2020年版)、《欧洲药典》(European Pharmacopoeia,EP)10.0、《美国药典》(United States Pharmacopoeia,USP)和WHO指南(Recommendations to assure the quality,s...目的:探讨23价肺炎球菌多糖疫苗质量控制标准。方法:对《中国药典》三部(2020年版)、《欧洲药典》(European Pharmacopoeia,EP)10.0、《美国药典》(United States Pharmacopoeia,USP)和WHO指南(Recommendations to assure the quality,safety and efficacy of pneumococcal conjugate vaccines,Annex 3.)中的23价肺炎球菌多糖疫苗质量标准进行比较研究。结果:《中国药典》2020年版三部23价肺炎球菌多糖疫苗质量标准比较全面,方法可行、适用。结论:《中国药典》2020年版三部中关于23价肺炎球菌多糖疫苗质量标准适用于该疫苗工艺的质量控制。展开更多
文摘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-Barré 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)
文摘目的:探讨23价肺炎球菌多糖疫苗质量控制标准。方法:对《中国药典》三部(2020年版)、《欧洲药典》(European Pharmacopoeia,EP)10.0、《美国药典》(United States Pharmacopoeia,USP)和WHO指南(Recommendations to assure the quality,safety and efficacy of pneumococcal conjugate vaccines,Annex 3.)中的23价肺炎球菌多糖疫苗质量标准进行比较研究。结果:《中国药典》2020年版三部23价肺炎球菌多糖疫苗质量标准比较全面,方法可行、适用。结论:《中国药典》2020年版三部中关于23价肺炎球菌多糖疫苗质量标准适用于该疫苗工艺的质量控制。
文摘目的评价≥2岁健康人群接种23价肺炎球菌多糖疫苗(Pneumococcal polysaccharide vaccine,PPV23)的安全性和免疫原性。方法采用开放性Ⅳ期临床试验,招募2-5岁、6-15岁、16-59岁和≥60岁健康受试者,观察1剂次PPV23接种后30 d内不良事件,分析发生率;检测接种前和接种后30 d血清标本23种肺炎链球菌(Streptococcus pneumoniae,Spn)血清型IgG抗体,评价接种后抗体阳转率、几何平均浓度(Geometric mean concentration,GMC)和几何平均增长倍数(Geometric mean increase,GMI)。结果在2997例受试者中,PPV23接种后与疫苗有关的不良事件发生率为10.84%(325例),其中1级、2级、3级、4级不良事件分别为9.94%、0.77%、0.13%、0.00%;接种部位疼痛、发热分别为4.50%、1.40%。在273例受试者中,PPV23接种后23种Spn血清型IgG抗体阳转率在92.83%-99.66%之间,GMC在2.00-63.34μg/mL之间,GMI在6.82-171.24之间。结论≥2岁健康人群接种1剂次PPV23具有良好的安全性和免疫原性。
