Post-Licensure Observational Safety Study of Gardasil 9

In December 2014, the FDA approved the Human Papillomavirus (HPV) 9-valent vaccine, Gardasil 9, for use in young males (9-15 years of age) and females (9-26 years of age). While clinical trials in large populations have shown that Gardasil 9 is generally safe and well tolerated, this observational study is being conducted by Merck and Co., Inc. as a post-licensure regulatory commitment to the FDA to monitor the general safety of Gardasil 9 when administered as part of routine health care.

0