Table 1 Pre-defined analysis sets to be used in summaries and analyses

All randomised participants with their treatment group as randomised. Participants who received vaccines/medications violating the exclusion criteria but were enrolled will be included.

All randomised participants who received as planned the vaccine strategy to which they were randomised, and who completed the whole study period according to the protocol (satisfied inclusion and exclusion criteria, and visits as scheduled).

All participants in the ITT set who were enrolled under stage 1 protocol at the Perth Children’s Hospital (PCH)/Telethon Kids Institute (TKI).

All participants in the per-protocol set who were enrolled under stage 1 protocol at PCH/TKI site and who met none of the stage 1 per-protocol exclusion criteria and who did not receive any contraindicated vaccines or medications for stage 1.

All participants in the ITT who were enrolled under stage 1 protocol or under the stage 2 protocol at PCH/TKI who consented for the blood samples.

All participants in the stage 1 assay set with the inclusion of the additional participants enrolled under the stage 2 protocol at PCH/TKI who consented for the blood samples and who satisfied all stage 1 and 2 inclusion/exclusion criteria.