At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 107 enrolled
Drug / intervention
Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (V501) +1 morebiological
Likely dose
Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (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.
V501 Phase II Immunogenicity Study in Females Aged 9 to 17 Years
In Brief
A Phase 2 clinical trial evaluating Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (V501) and Comparator: Placebo (unspecified) for HPV Infections. Completed, enrolled 107 participants.
Detailed Summary
The study evaluates the immunogenicity, safety and tolerability of V501 in preadolescent females
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHPV Infections
Countries--
Collaborators--
Timeline
Phase 2CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartDec 2006
First PostedDec 2006
Primary CompletionSep 2009
TodayJul 2026
First PostedDec 15, 2006
Enrollment StartDec 11, 2006
Primary CompletionSep 18, 2009
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 19.5 years ago
Interventions
Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (V501)biological
V501; Gardasil, 0.5 ml injection in 3 dosing regimen
Comparator: Placebo (unspecified)biological
Placebo 0.5 ml injection in 3 dosing regimen