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NCT01034358 · ClinicalTrials.gov registry record · Phase 4
Immune Response to the Human Papillomavirus Vaccine in Young Women With Inflammatory Bowel Disease
A Phase 4 study of Inflammatory Bowel Disease and Uterine Cervical Dysplasia, sponsored by Mayo Clinic.
- Completed
- Registry status
- Phase 4
- Development phase
- 15
- Enrollment target
- 1
- Study location
NCT01034358: Completed Phase 4 study of Inflammatory Bowel Disease and Uterine Cervical Dysplasia, sponsored by Mayo Clinic.
NCT01034358 is a Phase 4 study of Inflammatory Bowel Disease and Uterine Cervical Dysplasia that has completed, run by Mayo Clinic. The registered enrollment target is 15 participants, below the 403-participant average among 28 other Inflammatory Bowel Disease trials with a reported enrollment target (96% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01034358, a Phase 4 study of Inflammatory Bowel Disease and Uterine Cervical Dysplasia, has completed, sponsored by Mayo Clinic.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 15 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
Anti-HPV levels were determined by an assay conducted by Merck \& Co, Inc. and expressed as milliMerck units per milliliter (mMU/mL).
Conditions Studied
Interventions
- BIOLOGICAL Human Papillomavirus Vaccine
Study Locations (1)
Minnesota
- Mayo Clinic - Rochester
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2010-02 |
| Est. Completion | 2011-06 |
| Phase | Phase 4 |
What the finished NCT01034358 record still lists
NCT01034358 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 403-participant average among 28 other Inflammatory Bowel Disease trials with a reported enrollment target (96% lower).
The record links to 2 conditions, with Inflammatory Bowel Disease appearing as the primary indexed condition, and to 1 intervention - of which Human Papillomavirus Vaccine is the first listed.
NCT01034358 reports a single indexed study location in Minnesota.
Frequently Asked Questions
What is clinical trial NCT01034358 about?
NCT01034358 is a clinical study titled "Immune Response to the Human Papillomavirus Vaccine in Young Women With Inflammatory Bowel Disease". 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 immunosuppress...
What is the current status of trial NCT01034358?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 15 participants. The study started on 2010-02. Estimated completion is 2011-06.
What conditions does trial NCT01034358 study?
This clinical trial studies the following conditions: Inflammatory Bowel Disease, Uterine Cervical Dysplasia.
What interventions are being tested in trial NCT01034358?
The interventions under investigation include: Human Papillomavirus Vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT01034358?
This trial is sponsored by Mayo Clinic, which has 2,844 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01034358 being conducted?
This trial has 1 study location across Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Inflammatory Bowel Disease
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01034358's enrollment target sits among peer trials
15 27th of 28 higher than 2 of 28 other Inflammatory Bowel Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Inflammatory Bowel Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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