At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 15 enrolled
Drug / intervention
Human Papillomavirus Vaccinebiological
Likely dose
Human Papillomavirus Vaccine 0.5mLfrom 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.
Comparison of Immune Response to the Human Papillomavirus Vaccine in Young Women With and Without Inflammatory Bowel Disease
In Brief
A Phase 4 clinical trial evaluating Human Papillomavirus Vaccine for Inflammatory Bowel Disease and Uterine Cervical Dysplasia. Completed, enrolled 15 participants across 1 site.
Detailed Summary
The Gardasil vaccine, a vaccine targeted towards the human papillomavirus (HPV), has been shown to prevent the transmission of several strains of HPV in young women. Women with inflammatory bowel disease (IBD) may not respond as well to this vaccine, either due to having IBD or due to immunosuppressants used to control IBD. This study will test how well women with IBD respond to the Gardasil vaccine.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
CollaboratorsMerck Sharp & Dohme LLC
Timeline
Phase 4CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedDec 2009
Enrollment StartFeb 2010
Primary CompletionJun 2011
TodayJul 2026
First PostedDec 17, 2009
Enrollment StartFeb 1, 2010
Primary CompletionJun 1, 2011
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 16.5 years ago
Interventions
Human Papillomavirus Vaccinebiological
0.5mL intramuscular for 3 doses at 0, 2, and 6 months