Potential Mechanisms for Intussusception After Rotavirus Vaccine-Pilot Study
Status:
Completed
Trial end date:
2017-05-01
Target enrollment:
Participant gender:
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.