The ORVAC trial protocol: a phase IV, double-blind, randomised, placebo-controlled clinical trial of a third scheduled dose of Rotarix rotavirus vaccine in Australian Indigenous infants to improve protection against gastroenteritis
Bianca Fleur Middleton, Mark A Jones, Claire S Waddington, Margaret Danchin, Carly McCallum, Sarah Gallagher, Amanda Jane Leach, Ross Andrews, Carl Kirkwood, Nigel Cunliffe, Jonathan Carapetis, Julie A Marsh, Tom Snelling
BMJ OPEN | BMJ PUBLISHING GROUP | Published : 2019
INTRODUCTION: Rotavirus vaccines were introduced into the Australian National Immunisation Program in 2007. Despite this, Northern Territory Indigenous children continue to be hospitalised with rotavirus at a rate more than 20 times higher than non-Indigenous children in other Australian jurisdictions, with evidence of waning protection in the second year of life. We hypothesised that scheduling an additional (third) dose of oral human rotavirus vaccine (Rotarix, GlaxoSmithKline) for children aged 6 to <12 months would improve protection against clinically significant all-cause gastroenteritis. METHODS AND ANALYSIS: This Bayesian adaptive clinical trial will investigate whether routinely sch..View full abstract
Awarded by National Health Medical Research Council (NHMRC)
Awarded by NHMRC
Awarded by NHMRC Career Development Fellowship
lThis work was supported by the National Health Medical Research Council (NHMRC) (1086952). BFM is supported by an NHMRC Postgraduate Scholarship (1134095), a RACP P&CHD NHMRC Scholarship and a Douglas and Lola Douglas Scholarship in Medical Science, Australian Academy of Science. TS is supported by an NHMRC Career Development Fellowship (1111657). MD is supported by a David Bickart Clinician Research Fellowship, University of Melbourne.