At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 1,212 enrolled
Drug / intervention
V503biological
Likely dose
V503 (GARDASIL 9) 0.5 mL in a 3-dose regimen administered on Day 1, Month 2, and Month 6AI-extracted
Key inclusion· 1
- ✓Good physical health
Key exclusion· 9
- ✕History of abnormal Pap test or abnormal cervical biopsy results
- ✕History of HPV-related condition
- ✕Prior HPV vaccine vaccination
- ✕Pregnant
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
An Open-Label Phase III Clinical Trial to Study the Immunogenicity and Tolerability of GARDASIL®9 (A Multivalent Human Papillomavirus [HPV] L1 Virus-Like Particle [VLP] Vaccine) in Adult Women (27- to 45-Year-Olds) Compared to Young Adult Women (16 to 26 Year Olds)
In Brief
A Phase 3 clinical trial evaluating V503 for Cervical Cancer and 4 related conditions. Completed, enrolled 1,212 participants across 24 sites in 6 countries.
Detailed Summary
This study will assess the safety and immunogenicity of GARDASIL®9 (V503) in 16- to 45-year-old women. The primary hypothesis of the study states that anti-HPV 16, 18, 31, 33, 45, 52, and 58 geometric mean titers (GMTs) at 4 weeks postdose 3 are non-inferior in adult women as compared with GMTs in young adult women.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCervical Cancer, Vulvar Cancer, Vaginal Cancer, Genital Warts, Human Papillomavirus Infection
CountriesAustria, Belgium, Finland, Germany, Italy, Spain
Collaborators--
Timeline
Phase 3CompletedFinished
201820192020202120222023202420252026
First PostedMay 2017
Enrollment StartSep 2017
Primary CompletionNov 2018
TodayJul 2026
First PostedMay 18, 2017
Enrollment StartSep 20, 2017
Primary CompletionNov 19, 2018
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 9.1 years ago
Interventions
V503biological
V503 vaccination, 0.5 mL in a 3-dose regimen administered on Day 1, Month 2, and Month 6