Discussion
culture-proven
The main findings of our study are the identified protective threshold levels of IgG anti–The findings from this re-analysis of data from In the RCT comprising young adults, where we used individual-level data, confirming the Prentice criteria [In children, we used the population-based predicted VEThe conversion of endpoint titres to EU enabled the identification of a ‘dose-response’ relationship between the antibody levels and protection levels across the two trials. The 6.6 EU threshold level (corresponding to 1600 endpoint titre) was measured 17 days post-vaccination in young adults and predicted 73.6% VE against culture-proven We found a strong significant correlation between IgG anti–The main strength of our study is the utilization of data from the only two available Our study has limitations, including the lack of day 17 post-vaccination sera in 18% of the adult RCT volunteers and the availability of sera only for 10% of the participants in the paediatric RCT, the latter allowed only for using the reverse cumulative distribution analytical approach in children. Lastly, the number of There is a need to harmonize internationally between the ELISA assays employed and generate an International Standard Serum. This will enable assay results to reach a maximum external validity for the threshold levels of serum IgG antibodies to The findings of this study on serum IgG anti–