Table 2.
Unsolicited Adverse Events, >1% Incidence Overall, Following the 21-Day Period After Each Dose of A(H1N1)pdm09 Vaccine
| Adverse Event | Group A (N = 28) |
Group B (N = 33) |
Group C (N = 29) |
Group D (N = 28) |
||||
|---|---|---|---|---|---|---|---|---|
| n | % (95% CI) | n | % (95% CI) | n | % (95% CI) | n | % (95% CI) | |
| ≥1 adverse event | 8 | 28.6 (13.2–48.7) | 6 | 18.2 (7.0–35.5) | 7 | 24.1 (10.3–43.5) | 5 | 17.9 (6.1–36.9) |
| Nausea | 1 | 3.6 (0.1–18.3) | 0 | 0.0 (0.0–10.6) | 2 | 6.9 (0.8–22.8) | 1 | 3.6 (0.1–18.3) |
| Vomiting | 0 | 0.0 (0.0–12.3) | 0 | 0.0 (0.0–10.6) | 1 | 3.4 (0.1–17.8) | 1 | 3.6 (0.1–18.3) |
| Nasopharyngitis | 1 | 3.6 (0.1–18.3) | 1 | 3.0 (0.1–15.8) | 0 | 0.0 (0.0–11.9) | 0 | 0.0 (0.0–12.3) |
| Sinusitis | 1 | 3.6 (0.1–18.3) | 1 | 3.0 (0.1–15.8) | 0 | 0.0 (0.0–11.9) | 0 | 0.0 (0.0–12.3) |
| Upper respiratory tract infection | 0 | 0.0 (0.0–12.3) | 1 | 3.0 (0.1–15.8) | 1 | 3.4 (0.1–17.8) | 1 | 3.6 (0.1–18.3) |
| Oropharyngeal pain | 1 | 3.6 (0.1–18.3) | 0 | 0.0 (0.0–10.6) | 1 | 3.4 (0.1–17.8) | 0 | 0.0 (0.0–12.3) |
| Rhinorrhea | 1 | 3.6 (0.1–18.3) | 0 | 0.0 (0.0–10.6) | 1 | 3.4 (0.1–17.8) | 0 | 0.0 (0.0–12.3) |
Data shown are of the total vaccinated cohort. Groups A and B received trivalent seasonal influenza vaccine at day 0 and either adjuvanted (group A) or nonadjuvanted (group B) pandemic vaccine at day 122 and day 143. Groups C and D received saline at day 0 and adjuvanted (group C) or nonadjuvanted (group D) pandemic vaccine at day 122 and day 143. Abbreviations: CI, confidence interval; N, number of participants with the administered dose; n/%, number/percentage of participants reporting the symptom at least once.