Merck documents positive top-line outcomes from phase 3 trial assessing efficacy and safety of Gardasil 9 in Japanese males

Merck (known as MSD outside the U.S. and Canada) reported positive top-line results from a Phase 3 trial (V503-064) evaluating Gardasil 9, a 9-valent HPV vaccine, in Japanese males aged 16-26. The trial achieved its primary and secondary goals, showing that a 3-dose Gardasil 9 regimen significantly lowered the incidence of anogenital persistent infections caused by nine HPV strains, compared to a placebo.

A decade after Gardasil 9's initial approval, Merck continues expanding its evaluation to new patient groups, aiming to prevent HPV-related cancers globally through accessible vaccination. These new findings further confirm the vaccine’s effectiveness in reducing persistent infections in males, potentially impacting the global burden of HPV-related diseases.

Merck plans to submit these results to regulatory bodies in Japan and worldwide. Full data will be presented at an upcoming scientific congress. The study enrolled 1,059 participants and is part of a broader clinical program that also investigates Gardasil 9's efficacy against oral HPV infections and head and neck cancers.