At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 1,021 enrolled
Drug / intervention
Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine +1 morebiological
Likely dose
Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine 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 Efficacy Study in Women Aged 18 to 26
In Brief
A Phase 2 clinical trial evaluating Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine and Comparator: Placebo for HPV Infections. Completed, enrolled 1,021 participants.
Detailed Summary
A study to evaluate the efficacy, immunogenicity, safety and tolerability of V501 in adult women
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHPV Infections
Countries--
Collaborators--
Timeline
Phase 2CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartJun 2006
First PostedSep 2006
Primary CompletionSep 2009
TodayJul 2026
First PostedSep 20, 2006
Enrollment StartJun 12, 2006
Primary CompletionSep 16, 2009
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 19.8 years ago
Interventions
Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccinebiological
V501; Gardasil, 0.5 ml injection in 3 dosing regimen
Comparator: Placebobiological
Placebo 0.5 ml injection in 3 dosing regimen