Efficacy of the vedolizumab IV and SC formulations has been demonstrated in completed studies of adult subjects with moderately to severely active UC or CD. Clinical trial results are needed to affirm proper dosing, exposure, efficacy and safety for use of vedolizumab in pediatric patients. Subsequent to preliminary positive results from the completed pediatric phase 2, vedolizumab IV is being further evaluated in the phase 3 Studies MLN0002-3024 and MLN0002-3025 (subjects aged 2 to 17 years). Confirmatory positive results from these studies would support submission for registration of vedolizumab IV for pediatric patients. Vedolizumab SC is being evaluated in the proposed study to provide an alternative administration route of vedolizumab for maintenance treatment in the
same pediatric population