Table 3.
Demographic and Baseline Characteristics for Participants Aged 4–60 Years (Placebo-Controlled Trials Safety Pool, Safety Set)
| Characteristic | Participants, No. (%)a | |
|---|---|---|
| TAK-003 (n = 14 627) | Placebo (n = 7167) | |
| Age, y | ||
| ȃMean (SD) | 11.4 (8.36) | 10.3 (5.66) |
| ȃMedian (range) | 10.0 (4.0–60.0) | 10.0 (4.0–60.0) |
| Age category | ||
| ȃChildren (aged 4–11 y) | 9210 (63.0) | 4728 (66.0) |
| ȃAdolescents (aged 12–17 y) | 4629 (31.6) | 2287 (31.9) |
| ȃAdults (aged 18–60 y) | 788 (5.4) | 152 (2.1) |
| Gender | ||
| ȃMale | 7295 (49.9) | 3659 (51.1) |
| ȃFemale | 7332 (50.1) | 3508 (48.9) |
| Body mass indexb | (n = 14 617) | (n = 7167) |
| ȃMean (SD) | 18.4 (4.49) | 18.0 (3.96) |
| ȃMedian (range) | 17.1 (8.5–64.8) | 16.9 (8.8–42.1) |
| Race | ||
| ȃAsian | 6033 (41.2) | 3069 (42.8) |
| ȃAmerican Indian or Alaska Nativec | 5469 (37.4) | 2762 (38.5) |
| ȃBlack or African American | 1643 (11.2) | 819 (11.4) |
| ȃWhite | 937 (6.4) | 253 (3.5) |
| ȃMultiracial or otherd | 545 (3.7) | 216 (3.0) |
| ȃUnknown race | 0 | 48 (0.7) |
| Region | ||
| ȃLatin America | 7807 (53.4) | 3962 (55.3) |
| ȃAsia Pacific | 6032 (41.2) | 3074 (42.9) |
| ȃNorth America | 788 (5.4) | 131 (1.8) |
| Region endemic status | ||
| ȃEndemic | 13 539 (92.6) | 6936 (96.8) |
| ȃNonendemic | 1088 (7.4) | 231 (3.2) |
| Baseline dengue serostatuse | ||
| ȃSeropositive | 9808 (67.1) | 4975 (69.4) |
| ȃSeronegative | 4472 (30.6) | 2063 (28.8) |
| ȃUnknown | 347 (2.4) | 129 (1.8) |
| Flavivirus vaccination status | ||
| ȃExposed (YF or JE vaccine) | 6030 (41.2) | 2996 (41.8) |
| ȃNot exposed | 8597 (58.8) | 4171 (58.2) |
Abbreviations: JE, Japanese encephalitis; SD, standard deviation; YF, yellow fever.
Data represent no. (%) of participants unless otherwise specified.
Body mass index calculated as weight in kilograms divided by height in meters squared.
Owing to limited selection options on the case report form, this category was most frequently selected as the participant’s race in Latin American countries.
Includes the category “Native Hawaiian or other Pacific Islander.”
Seropositive defined as reciprocal neutralizing antibody titer of ≥10 against ≥1 dengue virus serotype at baseline; seronegative, as no detectable antibody titers against any dengue virus serotype at baseline.