At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 600 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 [Types 6, 11, 16, 18] (Recombinant, Adsorbed)), Phase III Clinical Trial to Study the Immunogenicity and Tolerability of V503 (9-Valent Human Papillomavirus (HPV) Vaccine) in Preadolescent and Adolescent Girls (9- to 15-year-old)
In Brief
A Phase 3 clinical trial evaluating V503 and GARDASIL for Human Papillomavirus. Completed, enrolled 600 participants.
Detailed Summary
Primary objective: • To demonstrate that administration of V503 induces non-inferior Geometric Mean Titers (GMTs) (for serum anti-HPV16 and anti-HPV18) compared to GARDASIL. Secondary objectives: * To evaluate the tolerability of V503 in 9-15 year-old girls. * To summarize humoral immune response (anti-HPV 6, 11, 16, 18) induced by V503 or GARDASIL.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHuman Papillomavirus
Countries--
Collaborators--
Timeline
Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
Enrollment StartFeb 2011
First PostedFeb 2011
Primary CompletionDec 2011
TodayJul 2026
First PostedFeb 25, 2011
Enrollment StartFeb 23, 2011
Primary CompletionDec 20, 2011
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 15.4 years ago
Interventions
V503biological
9-valent HPV \[Types 6, 11, 16, 18, 31, 33, 45, 52, and 58\] L1 virus-like particle vaccine
GARDASILbiological
Quadrivalent HPV \[Types 6, 11, 16, and 18\] L1 virus-like particle vaccine