A Long-Term Extension Study of Vedolizumab in Children and Teenagers With Ulcerative Colitis (UC) or Crohn's Disease (CD)

The drug being tested in this study is Vedolizumab SC. Vedolizumab SC is being tested totreat pediatric participants with moderate to severe active UC or CD. This study willlook at the long‐term safety profile in pediatric participants who take vedolizumab SC.The study will enroll approximately 70 participants. This extension study consists of atreatment cohort and an observational cohort. Participants will continue receiving thesame dose and frequency of vedolizumab SC that was received at the last dose of theparent study VedolizumabSC‐3003 (NCT06100289).For the Treatment cohort participants will be randomized (1:1) to receive vedolizumab ineither a prefilled syringe (PFS) as part of an autoinjector pen (PFS+AI) or a PFS with aneedle safety device (PFS+NSD): ‐ Treatment Cohort: Vedolizumab 108 milligram (mg) PFS+AI ‐ Treatment Cohort: Vedolizumab 108 mg PFS+NSDThis multi‐center trial will be conducted globally. The overall time to participate inthis study is up to 2 years from the first dose in the study. Participants in thetreatment cohort will have a follow‐up safety visit of 18 weeks after their last dose ofstudy drug. Participants who will not be eligible for the treatment cohort will beenrolled in the observational cohort and will be followed for approximately 2 years afterthe last dose of vedolizumab SC received during Study VedolizumabSC‐3003 (NCT06100289).