Table 2 Percentage of participants reporting unsolicited adverse events (AEs) during the 30-day period after each injection given via the 0–2–6 months schedule (vaccine doses at 0–2–6 months and placebo at 12 months) and the 0–2–12 months schedule (vaccine doses at 0–2–12 months and placebo at 6 months) (total vaccinated cohort)
| Â | Percentage of participants (95% CI) | |
|---|---|---|
|  | 0–2–6 schedule (N = 100) | 0–2–12 schedule (N = 100) |
At least one unsolicited AE (overall) | 38.0 (28.5–48.3) | 40.0 (30.3–50.3) |
 Related to vaccination | 7.0 (2.9–13.9) | 7.0 (2.9–13.9) |
 Grade 3 intensity | 5.0 (1.6–11.3) | 9.0 (4.2–16.4) |
 Grade 3 and related to vaccination | 1.0 (0.0–5.4) | 3.0 (0.6–8.5) |
At least one unsolicited AE (by injection) | Â | Â |
 First injection at 0 months | 16.0 (9.4–24.7) | 20.0 (12.7–29.2) |
 Second injection at 2 months | 16.1 (9.3–25.2) | 20.4 (12.9–29.7) |
 Third injection at 6 months | 14.4 (7.9–23.4) | 11.3 (5.8–19.4) |
 Fourth injection at 12 months | 8.2 (3.4–16.2) | 9.7 (4.5–17.6) |
Unsolicited AEs reported in ≥ 4% of participants in at least one group |  |  |
 Nasopharyngitis | 6.0 (2.2–12.6) | 6.0 (2.2–12.6) |
 Back pain | 2.0 (0.2–7.0) | 4.0 (1.1–9.9) |
 Hypertension | 0 | 4.0 (1.1–9.9) |