Table 1.
Attributable Risk and Cumulative Incidence Estimates for the Pooled Studies (CYD14, CYD15, and CYD23/57) Over the 6-year Period in Participants Aged ≥9 and <9 Years old, According to Baseline Serostatus by MI M0, NS1 M13 (Th9) and TMLE
| Estimated incidence, per 1000 (95% CI) | ||||
|---|---|---|---|---|
| Age | Endpoint | CYD-TDV | Placebo | Attributable Risk (CYD-TDV–placebo) (per 1000) (95% CI) |
| Seropositive | ||||
| ≥9 years | Hospitalized VCD | |||
| MI M0 | 4.21 (2.42, 6.00) | 19.93 (15.92, 23.93) | –15.71 (–20.05, –11.37) | |
| NS1 M13 (Th9) | 3.71 (2.66, 4.75) | 16.95 (13.61, 20.29) | –13.25 (–16.74, –9.75) | |
| TMLE | 3.61 (2.04, 5.18) | 17.32 (13.62, 21.03) | –13.7 (–17.7, –10) | |
| Severe VCD | ||||
| MI M0 | 0.85 (0.15, 1.54) | 4.95 (3.15, 6.75) | –4.10 (–6.02, –2.18) | |
| NS1 M13 (Th9) | 0.76 (0.29, 1.22) | 4.19 (2.61, 5.76) | –3.43 (–5.08, –1.78) | |
| TMLE | 0.63 (0.11, 1.16) | 4.66 (2.78, 6.54) | –4.0 (–6.0, –2) | |
| <9 years | Hospitalized VCD | |||
| MI M0 | 28.91 (18.33, 39.49) | 58.24 (38.27, 78.21) | –29.33 (–51.28, –7.38) | |
| NS1 M13 (Th9) | 24.95 (18.79, 31.08) | 49.48 (35.34, 63.40) | –24.52 (–39.84, –9.21) | |
| TMLE | 29.42 (18.76, 40.08) | 51.47 (34.33, 68.60) | –22.0 (–42.2, –2) | |
| Severe VCD | ||||
| MI M0 | 7.28 (2.77, 11.79) | 13.31 (6.41, 20.21) | –6.03 (–14.16, 2.10) | |
| NS1 M13 (Th9) | 7.43 (4.25, 10.59) | 12.69 (6.33, 19.00) | –5.26 (–12.34, 1.82) | |
| TMLE | 9.55 (4.36, 14.74) | 17.42 (6.91, 27.93) | –7.9 (–19.6, 4) | |
| Seronegative | ||||
| ≥9 years | Hospitalized VCD | |||
| MI M0 | 21.14 (13.58, 28.71) | 16.35 (7.42, 25.28) | 4.79 (–6.56, 16.14) | |
| NS1 M13 (Th9) | 19.74 (14.12, 25.32) | 13.98 (7.80, 20.11) | 5.76 (–2.56, 14.07) | |
| TMLE | 17.52 (10.42, 24.62) | 11.32 (2.99, 19.65) | 6.2 (–4.7, 17) | |
| Severe VCD | ||||
| MI M0 | 4.49 (1.59, 7.39) | 1.98 (–.96, 4.92) | 2.51 (–1.52, 6.54) | |
| NS1 M13 (Th9) | 4.47 (1.90, 7.04) | .67 (.00, 1.97) | 3.80 (.92, 6.69) | |
| TMLE | 4.24 (1.47, 7.00) | 1.87 (–1.80, 5.54) | 2.4 (–2.2, 7) | |
| <9 years | Hospitalized VCD | |||
| MI M0 | 79.78 (58.34, 101.23) | 44.12 (19.28, 68.96) | 35.67 (4.03, 67.30) | |
| NS1 M13 (Th9) | 77.37 (60.93, 93.52) | 37.37 (23.47, 51.07) | 40.00 (18.65, 61.35) | |
| TMLE | 57.29 (-4.21,74.58) | 35.45 (15.97, 54.93) | 21.8 (-4.2, 48) | |
| Severe VCD | ||||
| MI M0 | 17.19 (8.74, 25.63) | 6.81 (–.28, 13.91) | 10.37 (–0.39, 21.14) | |
| NS1 M13 (Th9) | 13.82 (8.11, 19.49) | 6.22 (1.09, 11.32) | 7.60 (–0.05, 15.25) | |
| TMLE | 17.63 (8.52, 26.75) | 6.32 (–3.28, 15.92) | 11.3 (-1.9, 25) | |
All incidence and attributable risks are presented cumulatively over the study period up to month 72. Subjects with VCD cases before M13 were excluded from the NS1 M13 (Th9) analyses. Data pooled from the CYD14, CYD15, and CYD23/57 studies, except TMLE where data are pooled from the CYD14 and CYD15 studies.
Abbreviations: CI, confidence interval; MI, multiple imputation; M0, baseline; NS1 M13 (Th9), dengue anti-nonstructural protein-1 (NS1) IgG ELISA at M13 with seropositivity defined as ≥9 EU/mL (threshold 9); TMLE, targeted minimum loss-based estimation; VCD, virologically confirmed dengue.