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