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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.

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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).

Interventions

  • BIOLOGICAL Human Papillomavirus Vaccine

Study Locations (1)

Minnesota

  • Mayo Clinic - Rochester

Trial Details

FieldValue
Enrollment Target 15 participants
Start Date 2010-02
Est. Completion 2011-06
Phase Phase 4
Mayo Clinic

2,844 total trials

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.

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.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01034358, the US trial registry maintained by the National Library of Medicine. NCT01034358 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.