Table 5.
Percentage of participants with reported unsolicited adverse events and serious adverse events during the 31-day (Days 1–31) period after dTpa vaccination overall and by age group (total vaccinated cohorts)
| Overall N = 447 |
4–9 years N = 111 |
10–17 years N = 111 |
18–64 years N = 113 |
≥65 years N = 112 |
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|---|---|---|---|---|---|---|---|---|---|---|
| n | % (95% CI) | n | % (95% CI) | n | % (95% CI) | n | % (95% CI) | n | % (95% CI) | |
| Any unsolicited AEs | 52 | 11.6 (8.8–15.0) | 17 | 15.3 (9.2–23.4) | 10 | 9.0 (4.4–15.9) | 19 | 16.8 (10.4–25.0) | 6 | 5.4 (2.0–11.3) |
| Grade 3 | 7 | 1.6 (0.6–3.2) | 0 | 0.0 (0.0–0.0) | 1 | 0.9 (0.0–4.9) | 5 | 4.4 (1.5–10.0) | 1 | 0.9 (0.0–4.9) |
| Related to vaccination | 16 | 3.6 (2.1–5.7) | 4 | 3.6 (1.0–9.0) | 4 | 3.6 (1.0–9.0) | 6 | 5.3 (2.0–11.2) | 2 | 1.8 (0.2–6.3) |
| Grade 3 related to vaccination | 1 | 0.2 (0.0–1.2) | 0 | 0.0 (0.0–3.3) | 0 | 0.0 (0.0–3.3) | 1 | 0.9 (0.0–4.8) | 0 | 0.0 (0.0–3.2) |
| Medically attended AEs | 16 | 3.6 (2.1–5.7) | 8 | 7.2 (3.2–13.7) | 4 | 3.6 (1.0–9.0) | 4 | 3.5 (1.0–8.8) | 0 | 0.0 (0.0–3.2) |
| SAEs up to study end, n (%) | 1 (0.2) | 0 (0) | 1 (0.9) | 0 (0) | 0 (0) | |||||
N, number of participants; n (%), number (percentage) of participants reporting at least one AE; AE, adverse event; CI, confidence interval; dTpa, diphtheria-tetanus-acellular pertussis vaccine; SAE, serious AE.