V501 Safety and Efficacy Study in Japanese Women Aged 16 to 26 Years (V501-110)

Summary

This study evaluated the long-term safety of quadrivalent Human Papillomavirus (HPV) types 6, 11, 16, 18 vaccine and its effectiveness in the prevention of cervical intraepithelial neoplasia (CIN), adenocarcinoma in situ, and cervical cancer related to HPV in Japanese women.

Timeline

Start

2011-11-25

Primary completion

2016-08-27

Completion

2016-08-27

Publications

• Sakamoto M, Miyagi E, Sumi Y, Aisaka K, Kuno N, Nagano H, Asahara S, Han SR, Wakana A, Murata S, Sawata M, Tanaka Y. Effectiveness on high-grade cervical abnormalities and long-term safety of the quadrivalent human papillomavirus vaccine in Japanese women. J Infect Chemother. 2019 Jul;25(7):520-525. doi: 10.1016/j.jiac.2019.02.012. Epub 2019 Mar 15.

Drugs

Indications