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  • 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

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Paediatrics
Protocol
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

Authors

  • Bianca Fleur Middleton Global and Tropical Health Division, Menzies School of Health Research, Charles Darwin University, Darwin, Northern Territory, Australia PubMed articlesGoogle scholar articles
  • Mark A Jones Wesfarmers Centre of Vaccines and Infectious Diseases, Telethon Kids Institute, West Perth, Western Australia, Australia PubMed articlesGoogle scholar articles
  • Claire S Waddington Wesfarmers Centre of Vaccines and Infectious Diseases, Telethon Kids Institute, West Perth, Western Australia, AustraliaDepartment of Medicine, University of Cambridge School of Clinical Medicine, Cambridge, UK PubMed articlesGoogle scholar articles
  • Margaret Danchin Vaccine and Immunisation Research Group, Murdoch Childrens Research Institute, Parkville, Victoria, AustraliaDepartment of Paediatrics, University of Melbourne, Parkville, Victoria, Australia PubMed articlesGoogle scholar articles
  • Carly McCallum Wesfarmers Centre of Vaccines and Infectious Diseases, Telethon Kids Institute, West Perth, Western Australia, Australia PubMed articlesGoogle scholar articles
  • Sarah Gallagher Global and Tropical Health Division, Menzies School of Health Research, Charles Darwin University, Darwin, Northern Territory, Australia PubMed articlesGoogle scholar articles
  • Amanda Jane Leach Child Health Division, Menzies School of Health Research, Charles Darwin Univesity, Darwin, Northern Territory, Australia PubMed articlesGoogle scholar articles
  • Ross Andrews Global and Tropical Health Division, Menzies School of Health Research, Charles Darwin University, Brisbane, Queensland, Australia PubMed articlesGoogle scholar articles
  • Carl Kirkwood Enteric and Diarrheal Diseases, Bill and Melinda Gates Foundation, Seattle, Washington, USA PubMed articlesGoogle scholar articles
  • Nigel Cunliffe Clinical Infection, Microbiology and Immunology, University of Liverpool, Liverpool, UK PubMed articlesGoogle scholar articles
  • Jonathan Carapetis Wesfarmers Centre of Vaccines and Infectious Diseases, Telethon Kids Institute, West Perth, Western Australia, AustraliaFaculty of Health and Medical Sciences, Centre for Child Health Research, University of Western Australia, Crawley, Western Australia, Australia PubMed articlesGoogle scholar articles
  • Julie A Marsh Wesfarmers Centre of Vaccines and Infectious Diseases, Telethon Kids Institute, West Perth, Western Australia, Australia PubMed articlesGoogle scholar articles
  • Tom Snelling Wesfarmers Centre of Vaccines and Infectious Diseases, Telethon Kids Institute, West Perth, Western Australia, Australia PubMed articlesGoogle scholar articles
  1. Correspondence to Dr Bianca Fleur Middleton; bianca.middleton{at}menzies.edu.au
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Citation

Middleton BF, Jones MA, Waddington CS, et al
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
BMJ Open 2019;9:e032549. doi: 10.1136/bmjopen-2019-032549

Publication history

  • Received June 24, 2019
  • Revised September 17, 2019
  • Accepted October 15, 2019
  • First published November 14, 2019.
Online issue publication 
October 13, 2022
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© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.