Phase III trial of HZ/su for Herpes Zoster meets primary endpoint-GSK

Glaxo Smith Kline has announced that a pivotal Phase III study to assess the efficacy of HZ/su, an investigational vaccine for the prevention of Herpes Zoster, has met its primary endpoint. Analysis of the primary endpoint showed that HZ/su reduced the risk of shingles by 97.2 per cent in adults aged 50 years and older compared to placebo. These are the first results from the ZOster Efficacy study in adults aged 50 years and over (ZOE-50). The study, which started in August 2010, is ongoing in 18 countries and involves more than 16,000 individuals.

The full set of safety data from the ZOE-50 trial is currently being analysed and will be disclosed in the coming months. The Independent Data Monitoring Committee (IDMC) for the ZOE-50 study, in its ongoing review of the safety information up to 31 May 2014, raised no concerns regarding the continuation of the trial. Data from the ZOE-50 trial are expected to be presented at a forthcoming scientific conference and submitted for publication in a peer-reviewed journal.