Safety profile of live varicella virus vaccine (Oka/Merck): five-year results of the European Varicella Zoster Virus Identification Program (EU VZVIP).

BACKGROUND: VARIVAX (Oka/Merck) is a live varicella vaccine, licensed in Europe since 2003. In addition to routine safety surveillance, the Varicella Zoster Virus Identification Program (VZVIP) analyzes clinical samples to establish whether adverse events (AEs) are associated with wild-type (wt) or vaccine varicella zoster virus (vVZV) strain. The European VZVIP provides data on VZV clade distribution. METHODS: Samples were collected from patients with selected AEs; the VZV strain was determined using polymerase chain reaction. RESULTS: From October 2003 to September 2008, 1006 spontaneous AE reports were analyzed (88% non-serious). Samples from 76/585 cases with selected AEs were collected. Of 55 VZV-positive/typable samples, wtVZV was detected in 40 and vVZV in 15 samples. Most rashes (32/44)

[Performance evaluation of a tool for institutional protocol quality assurance]. / Evaluation de la performance d'un outil d'assurance qualité des protocoles institutionnels.

BACKGROUND: Few data are available on the quality of the protocols promoted by the University Hospital Centers (CHU) in France, and there is no standardised method for evaluating protocol quality. The Clinical Research Centre (CIC) of Nancy developed a checklist-based tool aimed at evaluating the quality of institutional protocols. OBJECTIVE: The objective of this study was to evaluate the performance of this tool for assessing the quality of the protocols promoted by the CHU. METHODS: A prospective parallel-group study design, controlled with cluster randomisation, was used. The checklist was applied within the Directions of Clinical Research (DRC) for 4 months. Sixty four protocols were analysed. RESULTS: Before intervention there was no significant difference in quality scores between the two groups. Compared with baseline, there was a significant improvement of the methodological and regulation median score (81.7 +/- 13.7 vs 90.4 +/- 9.2) only in the intervention group (p = 0.040). Changes in the two groups over time were not significantly different from each other using analysis of variance (p = 0.501). CONCLUSION: In an observation limited to 12 CHU in France, the quality of the promoted protocols was judged as suboptimal and able to be improved. Initiation of quality assurance tools, such as the one used in this study, was associated with some spontaneous improvement, but did not improve the result significantly.