At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 100 enrolled
Drug / intervention
V503biological
Likely dose
V503 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.
A Phase III Open-label, Safety, Tolerability and Immunogenicity Study of a 9-Valent Human Papillomavirus (HPV) L1 Virus-Like Particle (VLP) Vaccine Administered to 9- to 15-Year-Old Japanese Preadolescent and Adolescent Girls
In Brief
A Phase 3 clinical trial evaluating V503 for Papillomavirus Infections. Completed, enrolled 100 participants.
Detailed Summary
This study will evaluate the safety, tolerability, and immunogenicity of V503 in Japanese girls between the ages of 9 and 15 and will determine whether V503 induces an acceptable immune response to all human papillomavirus (HPV) strains contained in the vaccine. The success criterion for the primary analysis requires that point estimates for seroconversion rate be greater than 90% for all 9 HPV types.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPapillomavirus Infections
Countries--
Collaborators--
Timeline
Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedDec 2010
Enrollment StartJan 2011
Primary CompletionAug 2013
TodayJul 2026
First PostedDec 6, 2010
Enrollment StartJan 12, 2011
Primary CompletionAug 10, 2013
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 15.6 years ago
Interventions
V503biological
V503 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6