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
目的分析13价肺炎球菌多糖结合疫苗(Pneumococcal polysaccharide conjugate vaccine,PCV13)纳入青海省免疫规划(Expanded Program on Immunization,EPI)的成本效益。方法建立决策树-Markov模型,计算PCV13纳入青海省EPI的2021年出生队...目的分析13价肺炎球菌多糖结合疫苗(Pneumococcal polysaccharide conjugate vaccine,PCV13)纳入青海省免疫规划(Expanded Program on Immunization,EPI)的成本效益。方法建立决策树-Markov模型,计算PCV13纳入青海省EPI的2021年出生队列接种成本和肺炎球菌性疾病(Pneumococcal disease,PD)经济负担,与未纳入EPI相比的净效益和效益成本比(Benefit-cost ratio,BCR)。结果PCV13纳入青海省EPI与未纳入EPI相比,PCV13总接种成本将增加12845万元,PD总经济负担将减少12921万元,产生的净效益为76万元,BCR为1.01。具有成本效益的每剂次PCV13最高价格为460元。结论按照当前国产PCV13价格将PCV13纳入青海省EPI从全社会角度略具有成本效益,建议降低疫苗价格以进一步提高成本效益,适时将PCV13纳入青海省EPI。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)
文摘目的分析13价肺炎球菌多糖结合疫苗(Pneumococcal polysaccharide conjugate vaccine,PCV13)纳入青海省免疫规划(Expanded Program on Immunization,EPI)的成本效益。方法建立决策树-Markov模型,计算PCV13纳入青海省EPI的2021年出生队列接种成本和肺炎球菌性疾病(Pneumococcal disease,PD)经济负担,与未纳入EPI相比的净效益和效益成本比(Benefit-cost ratio,BCR)。结果PCV13纳入青海省EPI与未纳入EPI相比,PCV13总接种成本将增加12845万元,PD总经济负担将减少12921万元,产生的净效益为76万元,BCR为1.01。具有成本效益的每剂次PCV13最高价格为460元。结论按照当前国产PCV13价格将PCV13纳入青海省EPI从全社会角度略具有成本效益,建议降低疫苗价格以进一步提高成本效益,适时将PCV13纳入青海省EPI。
