Clinical Trial: Potential Mechanisms for Intussusception After Rotavirus Vaccine-Pilot Study

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional




Official Title: Potential Mechanisms for Intussusception After Rotavirus Vaccine-Pilot Study

Brief Summary: This is a prospective randomized clinical trial that aims to evaluate the potential effects of the first dose of rotavirus vaccines on gastrointestinal motility and anatomy and blood and stool cytokine responses. It will also assess the association between these outcomes and the pattern of the shedding of vaccine strain rotavirus in the stool. Infants will be randomized to one of four arms: monovalent rotavirus vaccine (Rotarix®, RV1) alone, RV1 with other recommended vaccines, pentavalent rotavirus vaccine (RotaTeq®, RV5) alone, or RV5 with other recommended vaccines. Data derived from the pilot study will be used to assess the feasibility of conducting a larger scale study.