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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Phase IV Open-Label, Descriptive Study to Evaluate the Safety and Effectiveness on the Incidence of HPV 6, 11, 16 and 18 Related CIN 2/3 or Worse of the Quadrivalent HPV (Types 6, 11, 16, 18) L1 Vir

Brief Summary: This study will evaluate 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.

Detailed Summary:
Sponsor: Merck Sharp & Dohme Corp.

Current Primary Outcome: Combined incidence of CIN 2/3 or worse related to HPV type 6, 11, 16, or 18 [ Time Frame: Up to Month 48 postvaccination ]

Pathology panel consensus diagnosis of CIN 2 or 3, adenocarcinoma in situ, invasive squamous cervical carcinoma, or invasive adenocarcinoma of the cervix, AND HPV type 6, 11, 16, or 18 detected in an adjacent section from the same tissue block


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Merck Sharp & Dohme Corp.

Dates:
Date Received: February 29, 2012
Date Started: November 22, 2011
Date Completion:
Last Updated: March 23, 2017
Last Verified: March 2017