GlaxoSmithKline plc (GSK,GSK.L) announced that new data from a Phase III clinical study supports the safety and efficacy of Shingrix in preventing shingles when given to adults 18 years and above shortly after undergoing autologous haematopoietic stem cell transplant. Shingrix is a non-live, recombinant adjuvanted subunit vaccine.
The study succeeded in its primary objective by demonstrating an efficacy of 68.17%. The vaccine reduced overall complications linked to shingles episodes by 77.76%. No safety issues related to the vaccine were detected during the study. GSK said it is evaluating these results together with those of other Phase III studies in immune-compromised patient populations.
Shingrix is now approved in Canada and US for the prevention of herpes zoster in adults aged 50 years and above. Regulatory reviews are currently underway in the European Union, Australia and Japan.
by RTT Staff Writer
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