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Article History

Received: 28 October 2025

Accepted: 16 March 2026

First Online: 7 April 2026

Declarations

:

: The study was approved by the Royal Children’s Hospital Melbourne Human Research Ethics Committee (Reference Number: 62586) in accordance with the Declaration of Helsinki. The protocol was approved by the ethics committee at each site and all participants provided informed consent. The trial was overseen by a steering committee and a data safety and monitoring board.

: Not applicable.

: PCR has received investigator-initiated research grants to his institution from Sanofi outside this work and has received institutional funding from GlaxoSmithKline and Sanofi for local and international lectures and from AstraZeneca, Clover Biopharmaceuticals, GlaxoSmithKline, Novavax, Sanofi, and Pfizer for participation in vaccine scientific advisory boards unrelated to this work. He has been an investigator in sponsored, multicentre vaccine trials for AstraZeneca, Moderna, Novavax, Pfizer, and Sanofi with funding to his institution. He is Chief investigator on an investigator led COVID-19 vaccine trial and institution has received funding from the Medical Research Future Fund. HSM has received investigator-initiated research grants to her institution from Sanofi and Pfizer outside this work. She has been an investigator in sponsored, multicentre vaccine trials for Iliad, Seqirus and Pfizer, with funding to her institution. She is a Chief investigator on an investigator led COVID-19 vaccine trial and institution has received funding from the Medical Research Future Fund. All other authors declare that they have no known competing financial interests or personal relationships that could appear to have influenced the work reported in this paper.