CYD 2357 flow chart 4014 children screened CYD

CYD 23/57 flow chart 4014 children screened (CYD 23 study) 12 ineligible 4002 randomised 2669 assigned to CYD-TDV group* 1333 assigned to control group* 2 not vaccinated (consent withdrawn) 3 not vaccinated (consent withdrawn) 2666 given first dose (safety analysis set) Reasons for exclusion (n=114) 6 lost to follow-up 0 SAE 6 other AEs 70 withdrew consent (not for safety) 32 withdrawn for protocol non-compliance 1331 given first dose (safety analysis set) Reasons for exclusion (n=55) 8 lost to follow-up 6 SAEs 1 other AEs 26 withdrew consent (not for safety) 14 withdrawn for protocol non-compliance 2552 completed up to Year 2 421 not enrolled in CYD 57 1276 completed up to Year 2 204 not enrolled in CYD 57 2131 contacted at Year 3 2131 completed up to Year 4 1072 enrolled in CYD 57 1072 contacted at Year 3 1072 completed up to Year 4 * 199 and 100 participants assigned to the immunogenicity subset in the CYD-TDV and control groups, respectively

10632 children screened CYD 14 flowchart 357 ineligible 10275 randomized 6851 assigned to CYD-TDV group* 3424 assigned to control group* 3 not vaccinated (consent withdrawn) 0 not vaccinated 6848 given first dose (safety analysis set) Reasons for exclusion (n=51) 5 lost to follow-up 4 SAEs 0 other AEs 37 withdrew consent (not for safety) 5 withdrawn for protocol non-compliance 3424 given first dose (safety analysis set) Reasons for exclusion (n=27) 1 lost to follow-up 1 SAEs 0 other AEs 23 withdrew consent (not for safety) 2 withdrawn for protocol non-compliance 6797 contacted at Year 2 Reasons for exclusion (n=34) 5 lost to follow-up 1 SAEs 0 other AEs 23 withdrew consent (not for safety) 5 withdrawn for protocol non-compliance 6763 contacted at Year 3 Reasons for exclusion (n=51) 8 lost to follow-up 3 SAEs 0 other AEs 30 withdrew consent (not for safety) 10 withdrawn for protocol non -compliance 6712 completed up to Year 4 3397 contacted at Year 2 Reasons for exclusion (n=17) 4 lost to follow-up 0 SAEs 0 other AEs 12 withdrew consent (not for safety) 1 withdrawn for protocol non-compliance 3380 contacted at Year 3 Reasons for exclusion (n=21) 1 lost to follow-up 3 SAEs 0 other AEs 14 withdrew consent (not for safety) 3 withdrawn for protocol non-compliance 3359 completed up to Year 4 * 1336 and 664 participants assigned to the immunogenicity subset in the CYD-TDV and control groups, respectively.

22838 children screened CYD 15 flowchart 1969 ineligible 20869 randomised 13920 assigned to CYD-TDV group* 4 not vaccinated (consent withdrawn) 2 received all doses, but were excluded for noncompliance with GCP 6949 assigned to control group* 9 not vaccinated (consent withdrawn) 13914 given first dose (safety analysis set) Reasons for exclusion (n=633) 106 lost to follow-up 7 SAEs 3 other AEs 476 withdrew consent (not for safety) 41 withdrawn for protocol non-compliance 13281 contacted at Year 2 Reasons for exclusion (n=207) 83 lost to follow-up 5 SAEs 0 other AEs 114 withdrew consent (not for safety) 5 withdrawn for protocol non-compliance 13074 contacted at Year 3 Reasons for exclusion (n=347) 87 lost to follow-up 12 SAEs 0 other AEs 209 withdrew consent (not for safety) 39 withdrawn for protocol non-compliance 12727 completed up to Year 4 6940 given first dose (safety analysis set) Reasons for exclusion (n=300) 46 lost to follow-up 9 SAEs 0 other AEs 231 withdrew consent (not for safety) 14 withdrawn for protocol non-compliance 6640 contacted at Year 2 Reasons for exclusion (n=95) 37 lost to follow-up 1 SAEs 0 other AEs 53 withdrew consent (not for safety) 4 withdrawn for protocol non-compliance 6545 contacted at Year 3 Reasons for exclusion (n=177) 41 lost to follow-up 10 SAEs 0 other AEs 99 withdrew consent (not for safety) 27 withdrawn for protocol non-compliance 6368 completed up to Year 4 * 1334 and 666 participants assigned to the immunogenicity subset in the CYD-TDV and control groups, respectively