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Background
The ZOE-50 (NCT01165177) and ZOE-70 (NCT01165229) phase 3 clinical trials showed that the adjuvanted recombinant zoster vaccine (RZV) was ≥90% efficacious in preventing herpes zoster in adults. Here we present a comprehensive overview of the safety data from these studies.Methods
Adults aged ≥50 (ZOE-50) and ≥70 (ZOE-70) years were randomly vaccinated with RZV or placebo. Safety analyses were performed on the pooled total vaccinated cohort, consisting of participants receiving at least one dose of RZV or placebo. Solicited and unsolicited adverse events (AEs) were collected for 7 and 30?days after each vaccination, respectively. Serious AEs (SAEs) were collected from the first vaccination until 12?months post-last dose. Fatal AEs, vaccination-related SAEs, and potential immune-mediated diseases (pIMDs) were collected during the entire study period.Results
Safety was evaluated in 14,645 RZV and 14,660 placebo recipients. More RZV than placebo recipients reported unsolicited AEs (50.5% versus 32.0%); the difference was driven by transient injection site and solicited systemic reactions that were generally seen in the first week post-vaccination. The occurrence of overall SAEs (RZV: 10.1%; Placebo: 10.4%), fatal AEs (RZV: 4.3%; Placebo: 4.6%), and pIMDs (RZV: 1.2%; Placebo: 1.4%) was balanced between groups. The occurrence of possible exacerbations of pIMDs was rare and similar between groups. Overall, except for the expected local and systemic symptoms, the safety results were comparable between the RZV and Placebo groups irrespective of participant age, gender, or race.Conclusions
No safety concerns arose, supporting the favorable benefit-risk profile of RZV. 相似文献Methods: Day 3 to day 7 after admission to a stroke unit, 64 persons with stroke were assessed twice, using the SwePASS, by two physiotherapists. Inter-rater reliability was determined using percentage-agreement and the rank-invariant method: relative position, relative concentration, and relative rank variance.
Results: The raters showed a percentage agreement of ≥75% in the assessments using the SwePASS. For 9 of the 12 items, the percentage agreement was >80%. For 8 of the 12 items, there was a statistically significant change in position, revealed in relative position values between 0.08 and 0.15. Three items had statistically significant positive relative concentration values between ?0.11 and 0.10. Except for a statistically significant negligible relative variance value of 0.01 for the items 1 and 8, there was no relative variance.
Conclusions: The SwePASS shows an acceptable inter-rater reliability, albeit with potential for improvement. The reliability can be improved by a consensus how to interpret the scale between the raters prior to implementation in the clinic. 相似文献