Table 1. Observed and imputed efficacy of CYD-TDV in all participants who received ≥1 injection (intention to treat) by serotype and genotype.
| CYD dengue vaccine group | Control group | Vaccine efficacy Observed |
Vaccine Efficacy with imputation for missing genotype data | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Cases | Person-years at risk | Density incidence (95% CI) | Cases | Person-years at risk | Density incidence (95% CI) | % | (95% CI) | % | (95% CI) | ||
| Serotype 1 | 63.1 | (52.7; 71.2) | 54.7 | (45.4; 62.3) | |||||||
| Genotype I CYD14CYD | 15 | 13742 | 0.1 (0.1; 0.2) | 18 | 6796 | 0.3 (0.2; 0.4) | 58.8 | (18.3; 79.5) | 57.4 | (29.7; 74.2) | |
| Genotype IV CYD14 | 40 | 13742 | 0.3 (0.2; 0.4) | 51 | 6796 | 0.8 (0.6; 1.0) | 61.3 | (41.5; 74.5) | 53.3 | (37.2; 65.3) | |
| Genotype V CYD15 | 53 | 27016 | 0.2 (0.1; 0.3) | 76 | 13434 | 0.6 (0.4; 0.7) | 65.3 | (50.9; 75.7) | 54.9 | (40.7; 65.6) | |
| p-value* | 0.8614 | 0.9912 | |||||||||
| Serotype 2 | 39.1 | (18.9; 54.3) | 43.0 | (29.4; 53.9) | |||||||
| American/Asian CYD15 | 48 | 27035 | 0.2 (0.1; 0.2) | 50 | 13461 | 0.4 (0.3; 0.5) | 52.2 | (28.9; 67.9) | 50.2 | (32.6; 63.2) | |
| Asian I CYD14CYD | 28 | 13766 | 0.2 (0.1; 0.3) | 14 | 6856 | 0.2 (0.1; 0.3) | 0.3 | (−94.9; 46.6) | 19.8 | (−30.0; 49.6) | |
| Cosmopolitan CYD14 | 28 | 13766 | 0.2 (0.1; 0.3) | 21 | 6856 | 0.3 (0.2; 0.5) | 33.8 | (−18.0; 62.2) | 43.8 | (16.1; 62.2) | |
| p-value* | 0.1469 | 0.2493 | |||||||||
| Serotype 3 | 75.1 | (62.9; 83.3) | 71.6 | (63.0; 78.3) | |||||||
| Genotype I CYD14 | 9 | 13835 | <0.1 (0.0; 0.1) | 14 | 6895 | 0.2 (0.1; 0.3) | 67.9 | (26.9; 86.6) | 58.1 | (25.2; 76.8) | |
| Genotype II CYD14CYD | 0 | 13835 | 0.0 (0.0; 0.0) | 4 | 6895 | <0.1 (0.0; 0.1) | 100.0 | (69.3; 100.0) | 85.8 | (41.1; 97.9) | |
| Genotype III CYD14 | 4 | 13835 | <0.1 (0.0; 0.1) | 7 | 6895 | 0.1 (0.0; 0.2) | 71.6 | (6.1; 92.6) | 68.4 | (19.8; 88.4) | |
| Genotype III CYD15 | 23 | 27060 | <0.1 (0.1; 0.1) | 47 | 13459 | 0.3 (0.3; 0.5) | 75.7 | (60.5; 85.5) | 74.2 | (64.3; 81.4) | |
| Genotype III CYD14 + CYD15 | 27 | 40896 | <0.1 (0.0; 0.1) | 54 | 20354 | 0.3 (0.2; 0.3) | 75.2 | (61.0; 84.6) | 73.7 | (64.3; 80.8) | |
| p-value* | 0.3751 | 0.2561 | |||||||||
| Serotype 4 | 74.1 | (61.7; 82.5) | 76.9 | (69.5; 82.6) | |||||||
| Genotype I CYD14 | 19 | 13826 | 0.1 (0.1; 0.2) | 18 | 6874 | 0.3 (0.2; 0.4) | 47.4 | (−0.9; 72.5) | 58.3 | (29.9; 75.2) | |
| Genotype II CYD14CYD | 8 | 13826 | <0.1 (0.0; 0.1) | 24 | 6874 | 0.3 (0.2; 0.5) | 83.5 | (64.8; 93.1) | 83.8 | (69.3; 91.5) | |
| Genotype II CYD15CYD | 11 | 27063 | <0.1 (0.0; 0.1) | 31 | 13442 | 0.2 (0.2; 0.3) | 82.4 | (66.0; 91.5) | 80.8 | (71.2; 87.3) | |
| Genotype II CYD14 + CYD15CYD | 19 | 40890 | <0.1 (0.0; 0.1) | 55 | 20316 | 0.3 (0.2; 0.4) | 82.9 | (71.7; 90.1) | 81.8 | (74.3; 87.1) | |
| p-value* | 0.0072 | 0.0086 | |||||||||
Cases: number of subjects with at least one sequenced symptomatic virologically-confirmed dengue episode during the active phase of follow-up.
Density incidence: data indicate cases per 100 person-years at risk.
*The p-value was obtained by testing the heterogeneity of genotype distribution between groups (within each serotype) using a Chi2 (or Fisher’s exact test).
CYD Genotype of the serotype-specific CYD-TDV vaccine component.