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Safety of a 13-valent Pneumococcal Conjugate Vaccine in Elderly Adults Previously Immunized with a 23-valent Pneumococcal Polysaccharide Vaccine: An Open-Label Trial

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World Journal of Vaccines 2013年第4期3卷 123-129页

作者： Tino F. Schwarz Karlis Pauksens Christine Juergens Deepthi Jayawardene Daniel A. Scott William C. Gruber Beate Schmoele-Thoma Central Laboratory and Vaccination Centre Stiftung Juliusspital Würzburg Germany Department of Medical Sciences Section of Infectious Diseases Uppsala University Akademiska Sjukhuset Uppsala Sweden Pfizer Inc. Collegeville USA Pfizer Pharma GmbH Berlin Germany Pfizer Vaccine Research Pfizer Pearl River USA

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)

关键词： 13-valent Pneumococcal Conjugate Vaccine 23-valent Pneumococcal Polysaccharide Vaccine Streptococcus pneumoniae Reactogenicity Safety

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