At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 1,781 enrolled
Drug / intervention
V501 +1 morebiological
Likely dose
V501 0.5 mL intramuscular injectionAI-extracted
Key inclusion· 2
- ✓Healthy adolescents and preadolescents
- ✓No prior sexual history
Key exclusion· 2
- ✕Compromised immune system
- ✕History of severe allergic reaction
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Safety and Immunogenicity Study of Quadrivalent HPV (Types 6, 11, 16, 18) L1 Virus-Like Particle (VLP) Vaccine in Preadolescents and Adolescents (Base Study). A Long Term Immunogenicity, Safety, and Effectiveness Study of GARDASIL (Human Papillomavirus [Types 6, 11, 16, 18] Recombinant Vaccine) Among Adolescents Who Received GARDASIL at 9-18 Years of Age (Extension Study).
In Brief
A Phase 3 clinical trial evaluating V501 and Comparator: Placebo for Human and Papillomavirus Infections. Completed, enrolled 1,781 participants.
Detailed Summary
This study is to evaluate the safety, tolerability, and immune response of an investigational vaccine in preadolescent and adolescent boys and girls for the prevention of Human Papilloma Virus (HPV).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHuman, Papillomavirus Infections
Countries--
Collaborators--
Timeline
Phase 3CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartOct 2003
First PostedSep 2004
Primary CompletionNov 2005
Study CompletionJun 2015
TodayJul 2026
First PostedSep 28, 2004
Enrollment StartOct 8, 2003
Primary CompletionNov 3, 2005
Study CompletionJun 1, 2015
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 21.8 years ago
Interventions
V501biological
0.5 mL intramuscular injection of V501
Comparator: Placebobiological
0.5 mL intramuscular injection of placebo