Table 2. Observed and imputed efficacy of CYD-TDV for subjects 9 years and older 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 | 67.7 | (56.1; 76.3) | 58.4 | (47.7; 66.9) | |||||||
| Genotype I CYD14CYD | 6 | 6683 | <0.1 (0.0; 0.2) | 8 | 3306 | 0.2 (0.1; 0.5) | 62.8 | (−6.8; 87.8) | 69.0 | (33.8; 85.5) | |
| Genotype IV CYD14 | 8 | 6683 | 0.1 (0.1; 0.2) | 19 | 3306 | 0.6 (0.3; 0.9) | 79.2 | (54.1; 91.4) | 64.0 | (39.7; 78.5) | |
| 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* | 0.5213 | 0.5400 | |||||||||
| Serotype 2 | 48.6 | (27.4; 63.7) | 47.1 | (31.3; 59.2) | |||||||
| 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 | 12 | 6687 | 0.2 (0.1; 0.3) | 9 | 3330 | 0.3 (0.1; 0.5) | 33.6 | (−62.7; 71.9) | 34.6 | (−27.4; 65.7) | |
| Cosmopolitan CYD14 | 5 | 6687 | <0.1 (0.0; 0.2) | 4 | 3330 | 0.1 (0.0; 0.3) | 37.8 | (−151; 83.5) | 40.3 | (−41.4; 74.3) | |
| p-value* | 0.7736 | 0.7253 | |||||||||
| Serotype 3 | 76.0 | (62.3; 84.7) | 73.6 | (64.4; 80.4) | |||||||
| Genotype I CYD14 | 4 | 6715 | <0.1 (0.0; 0.2) | 6 | 3347 | 0.2 (0.1; 0.4) | 66.8 | (−16.3; 91.5) | 61.2 | (−4.1; 86.1) | |
| Genotype II CYD14CYD | 0 | 6715 | 0.0 (0.0; 0.1) | 3 | 3347 | <0.1 (0.0; 0.3) | 100.0 | (55.4; 100.0) | 80.1 | (7.6; 97.1) | |
| Genotype III CYD14 | 1 | 6715 | <0.1 (0.0; 0.1) | 2 | 3347 | <0.1 (0.0; 0.2) | 75.1 | (−160; 98.8) | 75.1 | (−27.4; 96.6) | |
| 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 | 24 | 33775 | <0.1 (0.0; 0.1) | 49 | 16806 | 0.3 (0.2; 0.4) | 75.7 | (60.8; 85.3) | 74.3 | (64.7; 81.4) | |
| p-value* | 0.5928 | 0.6985 | |||||||||
| Serotype 4 | 85.2 | (74.6; 91.4) | 83.2 | (76.2; 88.2) | |||||||
| Genotype I CYD14 | 3 | 6716 | <0.1 (0.0; 0.1) | 12 | 3327 | 0.4 (0.2; 0.6) | 87.6 | (60.9; 97.2) | 86.2 | (63.6; 94.8) | |
| Genotype II CYD14CYD | 3 | 6716 | <0.1 (0.0; 0.1) | 14 | 3327 | 0.4 (0.2; 0.7) | 89.4 | (67.7; 97.6) | 89.6 | (70.5; 96.3) | |
| 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 | 14 | 33779 | <0.1 (0.0; 0.1) | 45 | 16769 | 0.3 (0.2; 0.4) | 84.6 | (72.6; 91.8) | 82.6 | (74.7; 88.1) | |
| p-value* | 1.0000 | 0.6678 | |||||||||
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.