The ORVAC trial: 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: a statistical analysis plan.

ABSTRACT:

Objective

The purpose of this double-blind, randomised, placebo-controlled, adaptive design trial with frequent interim analyses is to determine if Australian Indigenous children, who receive an additional (third) dose of human rotavirus vaccine (Rotarix, GlaxoSmithKline) for children aged 6 to < 12 months, would improve protection against clinically significant all-cause gastroenteritis.

Participants

Up to 1000 Australian Aboriginal and Torres Strait Islander (hereafter Indigenous) infants aged 6 to < 12 months will be recruited from all regions of the Northern Territory.

Interventions

The intervention is the addition of a third scheduled dose of human monovalent rotavirus vaccine.

Co-primary and secondary outcome measures

ORVAC has two co-primary outcomes: (1

SUBMITTER: Jones MA 

PROVIDER: S-EPMC7447587 | biostudies-literature | 2020 Aug

REPOSITORIES: biostudies-literature