At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 500 enrolled
Drug / intervention
V503 +1 morebiological
Likely dose
Not stated in 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 Randomized, Double-Blinded, Controlled With GARDASIL (Human Papillomavirus Vaccine [HPV] [Types 6, 11, 16, 18] (Recombinant, Adsorbed)), Phase 3 Clinical Trial to Study the Immunogenicity and Tolerability of V503 (9-Valent Human Papillomavirus L1 Virus-Like Particle [VLP] Vaccine) in 16- to 26-year-old Men
In Brief
A Phase 3 clinical trial evaluating V503 and GARDASIL for Papilloma Viral Infection. Completed, enrolled 500 participants across 7 sites in 3 countries.
Detailed Summary
Primary objective To demonstrate that administration of V503 induces non-inferior Geometric Mean Titres (GMTs) for serum anti-HPV 6, 11, 16, and 18, compared to GARDASIL in 16- to 26-year-old men
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPapilloma Viral Infection
CountriesBelgium, Germany, Netherlands
Collaborators--
Timeline
Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
Enrollment StartMar 2014
First PostedApr 2014
Primary CompletionApr 2015
TodayJul 2026
First PostedApr 15, 2014
Enrollment StartMar 24, 2014
Primary CompletionApr 22, 2015
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 12.2 years ago
Interventions
V503biological
9-valent HPV \[Types 6, 11, 16, 18, 31, 33, 45, 52, and 58\] L1 virus-like particle vaccine, 0.5-mL intramuscular injection
GARDASILbiological
Quadrivalent HPV \[Types 6, 11, 16, and 18\] L1 virus-like particle vaccine, 0.5-mL intramuscular injection