Immunogenicity of a Third Scheduled Dose of Rotarix in Australian Indigenous Infants: A Phase IV, Double-blind, Randomized, Placebo-Controlled Clinical Trial.
In: Journal of Infectious Diseases, Jg. 226 (2022-11-01), Heft 9, S. 1537-1544
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Zugriff:
Background: 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 <12 months old. Methods: ORVAC is a 2-stage, double-blind, randomized, placebo-controlled trial. Australian Aboriginal children 6 to <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. Results: 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% after Rotarix compared with 72% after placebo. There were no occurrences of intussusception or any serious adverse events. Conclusions: An additional dose of Rotarix administered to Australian Aboriginal infants 6 to <12 months old increased the proportion with a vaccine seroresponse. Clinical Trials Registration: NCT02941107. [ABSTRACT FROM AUTHOR]
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Titel: |
Immunogenicity of a Third Scheduled Dose of Rotarix in Australian Indigenous Infants: A Phase IV, Double-blind, Randomized, Placebo-Controlled Clinical Trial.
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Autor/in / Beteiligte Person: | Middleton, Bianca F ; Danchin, Margie ; Jones, Mark A ; Leach, Amanda J ; Cunliffe, Nigel ; Kirkwood, Carl D ; Carapetis, Jonathan ; Gallagher, Sarah ; Kirkham, Lea-Ann ; Granland, Caitlyn ; McNeal, Monica ; Marsh, Julie A ; Waddington, Claire S ; Snelling, Thomas L |
Zeitschrift: | Journal of Infectious Diseases, Jg. 226 (2022-11-01), Heft 9, S. 1537-1544 |
Veröffentlichung: | 2022 |
Medientyp: | academicJournal |
ISSN: | 0022-1899 (print) |
DOI: | 10.1093/infdis/jiac038 |
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