A Study of Vedolizumab in Children and Teenagers With Ulcerative Colitis or Crohn's Disease

Exclusion Criteria

• •1. Participants who have had previous exposure to approved or investigational anti-integrins, including but not limited to, natalizumab, efalizumab, etrolizumab, or abrilumab (AMG 181); or mucosal addressin cell adhesion molecule-1 (MAdCAM-1) antagonists (ontamalimab), or rituximab.
• •2. Participants who have had prior exposure to vedolizumab.
• •3. Participants with hypersensitivity or allergies to vedolizumab or any of its excipients.
• •4. Participants with active cerebral/meningeal disease, signs/symptoms or history of progressive multifocal leukoencephalopathy (PML) or any other major neurological disorders.
• •5. The participant has received any live vaccinations within 30 days before first dose of study drug.
• •6. Participants who currently require surgical intervention or are anticipated to require surgical intervention for UC or CD during this study.
• •7. Participants who have had subtotal or total colectomy or have a jejunostomy, ileostomy, colostomy, ileo-anal pouch, known fixed stenosis of the intestine, short bowel syndrome, or \>3 small intestine resections.
• •8. Participants with a current diagnosis of indeterminate colitis.
• •9. Participants with clinical features suggesting monogenic very early-onset inflammatory bowel disease (IBD).
• •10. Participants with active or latent tuberculosis (TB).
• •11. Participants with evidence of positive hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb). Hepatitis B virus (HBV) immune subjects (that is, HBsAg negative and hepatitis B surface antibody \[anti-HBs\]-positive) may, however, be included.
• •12. The participant has any identified congenital or acquired immunodeficiency (for example, common variable immunodeficiency, human immunodeficiency virus \[HIV\] infection, organ transplantation).
• •13. Participants with positive stool studies for ova and/or parasites or stool culture at screening visit.
• •14. Participants with positive Clostridioides difficile (C difficile) stool test at screening visit.