Shingrix vaccine succeeds in second Phase III study for Herpes Zoster (Shingles)-GSK
GlaxoSmithKline plc announced that the second pivotal phase III study of its candidate vaccine Shingrix in adults aged 70 years and over (known as ZOE-70) successfully met its primary objective, demonstrating 90% (95% confidence interval: 84–94) efficacy against shingles compared to placebo. The high efficacy seen in ZOE-70 is in line with the efficacy shown in the first pivotal phase III study in adults aged 50 years and over (ZOE-50) presented earlier this year .
In addition, a pre-specified pooled analysis of ZOE-70 and ZOE-50 data demonstrated that the candidate vaccine effectively prevents subsequent chronic neuropathic pain, also known as post-herpetic neuralgia (PHN) which is the most common severe complication of shingles. Shingrix was demonstrated to be 89% (95% confidence interval: 69– 97) efficacious in preventing PHN in people aged 70 years and over and 91% (95% confidence interval: 76– 98) efficacious in people aged 50 years and over. Based on these and the previously reported ZOE-50 data, GSK intends to submit a regulatory application for Shingrix for the prevention of shingles in people 50 years of age and over in North America, in Japan and EU during the second half of 2016.
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