CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 1,030 enrolled
Drug / intervention
V501biological
Likely dose
V501 0.5 mLfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01544478
NCT01544478Phase 4Completed
CompareCT.gov

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 Virus-Like Particle (VLP) Vaccine in 16- to 26-Year-Old Japanese Women

Merck Sharp & Dohme LLC·interventional·Posted Mar 6, 2012·Updated Nov 28, 2018

In Brief

A Phase 4 clinical trial evaluating V501 for Cervical Cancer and 2 related conditions. Completed, enrolled 1,030 participants.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCervical Cancer, Cervical Intraepithelial Neoplasia, Adenocarcinoma in Situ
Countries--
Collaborators--

Timeline

Phase 4CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedMar 6, 2012
Enrollment StartNov 25, 2011
Primary CompletionAug 27, 2016
TodayJul 2, 2026
Enrollment to primary: 4.8 yearsPosted 14.3 years ago

Interventions

V501biological

HPV types 6, 11, 16, and 18 vaccine 0.5 mL by intramuscular injection at Day 1, Month 2, and Month 6