# Immune Response to Systemic and Mucosal Antigenic Challenge in the Presence of Vedolizumab

> **NCT01981616** · PHASE1 · COMPLETED · sponsor: **Millennium Pharmaceuticals, Inc.** · enrollment: 127 (actual)

## Conditions studied

- Inflammatory Bowel Disease

## Interventions

- **DRUG:** Vedolizumab
- **DRUG:** Placebo
- **BIOLOGICAL:** Hepatitis B vaccine
- **BIOLOGICAL:** Oral cholera vaccine

## Key facts

- **NCT ID:** NCT01981616
- **Lead sponsor:** Millennium Pharmaceuticals, Inc.
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE1
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 2011-09
- **Primary completion:** 2012-05
- **Final completion:** 2012-07
- **Target enrollment:** 127 (ACTUAL)
- **Last updated:** 2014-07-21


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT01981616

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT01981616, "Immune Response to Systemic and Mucosal Antigenic Challenge in the Presence of Vedolizumab". Retrieved via AI Analytics 2026-05-28 from https://api.ai-analytics.org/clinical/NCT01981616. Licensed CC0.

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