A phase IV, double blind, randomised, placebo controlled clinical trial of a third scheduled dose of RV1 rotavirus vaccine in Australian Indigenous infants to improve protection against gastroenteritis

Abstract
We will conduct a phase IV double-blind, randomised, placebo-controlled clinical trial to optimise the effectiveness of RV1 oral rotavirus vaccine among Indigenous infants. Northern Territory Indigenous infants will be given either a third dose of rotavirus vaccine (Rotarix – RV1) or a matched placebo between the ages of 6 to 12 months. We will compare the immune responses between the two groups (as a marker of immune protection against rotavirus) as well as the frequency of hospital and clinic presentation for gastroenteritis in the first three years of life.
Link
Subject
Viral Gastroenteritis Due to Rotavirus
Title
A phase IV, double blind, randomised, placebo controlled clinical trial of a third scheduled dose of RV1 rotavirus vaccine in Australian Indigenous infants to improve protection against gastroenteritis
Type of document
Interventional/Clinical trials research
Entity Type
Project

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