At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 176 enrolled
Drug / intervention
Gardasil™ +1 morebiological
Likely dose
Gardasil 3-dose regimen (Day 1, Month 2, Month 6)AI-extracted
Key inclusion· 2
- ✓Girls ages 9 to 15 years who have not yet had coitarche (first sexual intercourse)
- ✓Healthy females ages 16 to 23 years with a lifetime history of 0 to 3 sexual partners
Key exclusion· 3
- ✕Prior vaccination with any HPV vaccine
- ✕(Ages 16–23 only) Any prior history of genital warts or treatment for genital warts
- ✕(Ages 16–23 only) More than 3 lifetime sexual partners (male or female)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
An Immunogenicity and Safety Study of Gardasil (V501 (Human Papillomavirus [Types 6, 11, 16, 18] Recombinant Vaccine)) in Females 9 to 23 Years of Age in Korea
In Brief
A Phase 3 clinical trial evaluating Gardasil™ and Placebo for Papillomavirus Infections. Completed, enrolled 176 participants.
Detailed Summary
This is an immunogenicity and safety study of Gardasil (V501) in females 9 to 23 years of age in Korea.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPapillomavirus Infections
Countries--
Collaborators--
Timeline
Phase 3CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 2005
Enrollment StartOct 2005
Primary CompletionJun 2006
TodayJul 2026
First PostedSep 12, 2005
Enrollment StartOct 1, 2005
Primary CompletionJun 1, 2006
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 20.8 years ago
Interventions
Gardasil™biological
Gardasil™ 3 dose regimen (Day 1, Month 2 and Month 6)
Placebobiological
Gardasil™ matching placebo 3 dose regimen (Day 1, Month 2 and Month 6)