Table 1 Analysis methods for secondary outcomes

Time from randomisation to hospitalisation for which the primary coded reason for admission is presumed or confirmed acute gastroenteritis or acute diarrhoea illness between randomisation and age 36 months.

Summary of the median and inter-quartile range for each treatment arm. The analysis will follow the form of the analysis for the primary clinical endpoint. We will provide a competing risk analysis as discussed in the main text.

Time from randomisation to hospitalisation for which rotavirus confirmed diarrhoea illness occurs between randomisation and age 36 months.

Summary of the median and inter-quartile range for each treatment arm. The analysis will follow the form of the analysis for the primary clinical endpoint. We will provide a competing risk analysis as discussed in the main text.

Time from randomisation to rotavirus infection meeting the jurisdictional case definition between randomisation and age 36 months.

Summary of the median and inter-quartile range for each treatment arm. The analysis will follow the form of the analysis for the primary clinical endpoint. We will provide a competing risk analysis as discussed in the main text.

Change in anti-rotavirus IgA log titre between administration of intervention (RV1/placebo) and 28 to 55 days post dose.

We will adopt a robust linear regression analysis assuming the errors follow t distribution with between 3 and 7 degrees of freedom.

Frequency of intussusception fulfilling Brighton criteria within the first 28 days after administration of the third dose

Descriptive summary.

Frequency of serious adverse events between randomisation and age 36 months.

Descriptive summary.