2024-03-13 06:45:02
Merck & Co said on Wednesday that it will conduct clinical trials of its human papillomavirus (HPV) vaccine Gardasil 9 to study the effectiveness and safety of a single-dose regimen compared to the approved three-dose regimen.
The company said it will conduct two separate studies testing Gardasil 9 in men and women aged 16 to 26 to examine whether a single dose of the vaccine provides comparable long-term protection to the approved three-dose regimen .
The large, multi-year studies are expected to begin in the fourth quarter of 2024, Merck said.
The drugmaker also plans to begin human trials in the fourth quarter for an experimental HPV vaccine that aims to provide broader protection by targeting multiple HPV types.
The U.S. Food and Drug Administration (FDA) first approved Gardasil 9 in 2014 to prevent certain types of cancer, including cervical, vulvar, vaginal and anal cancers, as well as diseases caused by nine HPV variants.
Gardasil 9 is now approved for use in women and men ages 9 to 45.
According to government data, HPV causes about 36,000 cases of cancer in men and women in the United States each year. (Reporting by Mariam Sunny in Bengaluru; Editing by Shounak Dasgupta)
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