Table 5.
Onset, duration, DENV PCR testing (when performed), and presumptive diagnosis in subjects with fever (≥ 38°C) during the 21-day period after each DENV/control vaccine dose by treatment group
| Full-dose DENV | 1/10 dose DENV | Control | |
|---|---|---|---|
| Dose 1 | N = 6 | N = 1 | N = 3 |
| Fever onset | |||
| Mean in days (range) | 6.7 (1–19) | 19 (19) | 17.0 (12–20) |
| Fever duration | |||
| Mean in days (range) | 1.8 (1–3) | 1 (1) | 2.0 (1–4) |
| Presumptive diagnosis | |||
| Isolated fever* | 3 | 0 | 1 |
| Acute pharyngitis | 1 | 0 | 2 |
| Acute gastritis/gastroenteritis | 1 | 1 | – |
| Influenza/ILI | 1 (PCR negative) | 0 | – |
| Dose 2 | N = 13 | N = 0 | N = 6 |
| Fever onset | |||
| Mean in days (range) | 10.4 (1–20) | – | 12.8 (5–19) |
| Fever duration | |||
| Mean in days (range) | 2.3 (1–7) | – | 1.8 (1–3) |
| Presumptive diagnosis | |||
| Isolated fever* | 4 | – | – |
| Acute pharyngitis | 8 (2 PCR negative) | – | 3 |
| Acute gastritis/gastroenteritis | 1 | – | 1 |
| Acute otitis media | – | – | 2 (1 PCR negative) |
*
Isolated fever cases had fever for 1 day without symptoms, which led to an organ-based diagnosis, and fever was presumed due to vaccine if the subject was in the DENV treatment group.