Optimising Rotavirus Vaccine in Aboriginal Children

Australian Indigenous children, particularly those living in remote communities, suffer a disproportionately high burden of rotavirus gastroenteritis disease. Despite the introduction of rotavirus vaccine into the Northern Territory (NT) Immunisation Schedule in 2006, the rate of hospitalization for rotavirus in NT Aboriginal children \< 5 years continues to be high, and the rate ratio of rotavirus hospitalisations for Indigenous versus non-Indigenous children has actually increased. The reasons for sub-optimal vaccine response are not completely understood, but both reduced vaccine immune responses and low vaccine coverage are likely to be important factors. The purpose of this study is to determine if Aboriginal children who receive an additional dose of RV1 between the ages of 6 and 12 months, will have an increase anti-rotavirus serum IgA seroconversion and decreased medical presentations with gastroenteritis in the first three years of life, compared to those who receive placebo.

NCT Number	NCT02941107
Lead Sponsor	Telethon Kids Institute Collaborators: Menzies School of Health Research
Conditions	Viral Gastroenteritis Due to Rotavirus
Enrollment	1,000 participants
Start Date	2018-03-27
Primary Completion	2026-07 (estimated)
Study Completion	2026-12 (estimated)
Updated on ClinicalTrials.gov	2024-03-06