Immunogenicity of a Third Scheduled Dose of Rotarix in Australian Indigenous Infants: A Phase IV, Double-blind, Randomized, Placebo-Controlled Clinical Trial

Bianca F Middleton, Margie Danchin, Mark A Jones, Amanda J Leach, Nigel Cunliffe, Carl D Kirkwood, Jonathan Carapetis, Sarah Gallagher, Lea-Ann Kirkham, Caitlyn Granland, Monica McNeal, Julie A Marsh, Claire S Waddington, Thomas L Snelling

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Abstract

Rotarix (GlaxoSmithKline) oral rotavirus vaccine is licensed as 2 doses in the first 6 months of life. In settings with high child mortality rates, clinical protection conferred by 2 doses of Rotarix is reduced. We assessed vaccine immune response when an additional dose of Rotarix was given to Australian Aboriginal children 6 to \lt;12 months old.ORVAC is a 2-stage, double-blind, randomized, placebo-controlled trial. Australian Aboriginal children 6 to \lt;12 months old who had received 1 or 2 prior doses of Rotarix rotavirus vaccine were randomized 1:1 to receive an additional dose of Rotarix or matched placebo. The primary immunological end point was seroresponse defined as an anti-rotavirus immunoglobulin A level ≥20 AU/mL, 28–56 days after the additional dose of Rotarix or placebo.Between March 2018 and August 2020, a total of 253 infants were enrolled. Of these, 178 infants (70\ had analyzable serological results after follow-up; 89 were randomized to receive Rotarix, and 89 to receive placebo. The proportion with seroresponse was 85\2\ to \lt;12 months old increased the proportion with a vaccine seroresponse.NCT02941107.
Original languageEnglish
Article numberjiac038
JournalThe Journal of infectious diseases
DOIs
Publication statusE-pub ahead of print - 1 Feb 2022

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