RV1 NCT02941107

Trial name or title	"Optimising Rotavirus Vaccine in Aboriginal Children"
Methods	Phase 4, double‐blind, randomized controlled trial
Participants	Number: 1000 Description: infants aged ≥ 6 months and < 12 months
Interventions	1. RV1 2. Placebo
Outcomes	1.Time to medical attendance (hospitalization, emergency department or medical clinic presentation) for which primary reason for presentation is presumed or confirmed acute gastroenteritis or acute diarrhoea illness before age 36 months 2. Anti‐rotavirus IgA seroconversion 3.Time to hospitalization for which the primary coded reason for admission is presumed or confirmed acute gastroenteritis or acute diarrhoea illness before age 36 months 4. Time to hospitalization for which rotavirus confirmed diarrhoea illness occurs before age 36 months 5. Rotavirus infection meeting the jurisdictional case definition 6. Change in anti‐rotavirus IgA log titre between administration of intervention (RV1/placebo) and 28 to 55 days post‐dose 7. The occurrence of intussusception fulfilling Brighton criteria 8. Serious adverse events
Starting date	March 2018 Completion: December 2020 (estimated)
Contact information	Tom Snelling, tom.snelling@telethonkids.org.au Carly McCallum, carly.foulis@telethonkids.org.au
Notes	Location: Australia Registration number: NCT02941107 Source of funding: Telethon Kids Institute