At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 1,447 enrolled
Drug / intervention
GSK Biologicals' HPV vaccine 580299biological
Likely dose
Not stated in 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.
Immunogenicity and Safety Study of GlaxoSmithKline Biologicals' HPV-16/18 L1 AS04 Vaccine When Administered According to Alternative 2-dose Schedules in 9 - 14 Year Old Females
In Brief
A Phase 3 clinical trial evaluating GSK Biologicals' HPV vaccine 580299 for Infections, Papillomavirus. Completed, enrolled 1,447 participants across 33 sites in 5 countries.
Detailed Summary
This study has been designed to evaluate the immunogenicity and safety of GSK Biologicals' HPV-16/18 vaccine when administered according to alternative 2-dose schedules (0,6 months and 0,12 months) in healthy 9-14 year old females as compared to the standard 3-dose schedule (0,1,6 months) in 15-25 year old females.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInfections, Papillomavirus
CountriesCanada, Germany, Italy, Taiwan, Thailand
Collaborators--
Timeline
Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedJun 2011
Enrollment StartJun 2011
Primary CompletionJun 2012
Study CompletionNov 2014
TodayJul 2026
First PostedJun 27, 2011
Enrollment StartJun 29, 2011
Primary CompletionJun 28, 2012
Study CompletionNov 13, 2014
TodayJul 2, 2026
Enrollment to primary: 12 monthsPosted 15.0 years ago
Interventions
GSK Biologicals' HPV vaccine 580299biological
Subjects received 2 or 3 doses of HPV vaccine administered intramuscularly.