TABLE 2.
Participants with solicited injection site and systemic reactions within 7 days of first immunization
| Reaction | No. (%, 90% CI) fora: |
|||
|---|---|---|---|---|
| Seronegative population |
Seropositive population |
|||
| 30 μg (n = 101) | 60 μg (n = 98) | 30 μg (n = 75) | 60 μg (n = 76) | |
| Local reactions | ||||
| Any | 63 (62.4, 53.8–70.4) | 57 (58.2, 49.4–66.6) | 44 (58.7, 48.5–68.3) | 48 (63.2, 53.1–72.4) |
| Swelling | 3 (3, 0.8–7.5) | 5 (5.1, 2–10.4) | 6 (8, 3.5–15.2) | 5 (6.6, 2.6–13.3) |
| Induration | 4 (4, 1.4–8.8) | 4 (4.1, 1.4–9.1) | 4 (5.3, 1.8–11.8) | 6 (7.9, 3.5–15) |
| Redness | 3 (3, 0.8–7.5) | 5 (5.1, 2–10.4) | 2 (2.7, 0.5–8.2) | 6 (7.9, 3.5–15) |
| Injection site pain | 42 (41.6, 33.3–50.3) | 36 (36.7, 28.6–45.5) | 32 (42.7, 33–52.8) | 37 (48.7, 38.8–58.7) |
| Tenderness | 50 (49.5, 40.9–58.1) | 40 (40.8, 32.4–49.6) | 31 (41.3, 31.7–51.5) | 23 (30.3, 21.6–40.1) |
| Systemic reactions | ||||
| Any | 30 (29.7, 22.3–38.1) | 29 (29.6, 22–38.1) | 19 (25.3, 17.3–34.9) | 14 (18.4, 11.5–27.3) |
| Malaise | 5 (5, 2–10.1) | 2 (2, 0.4–6.3) | 2 (2.7, 0.5–8.2) | 2 (2.6, 0.5–8.1) |
| Fatigue | 8 (7.9, 4–13.8) | 5 (5.1, 2–10.4) | 4 (5.3, 1.8–11.8) | 6 (7.9, 3.5–15) |
| Headache | 12 (11.9, 7–18.5) | 6 (6.1, 2.7–11.7) | 3 (4, 1.1–10) | 4 (5.3, 1.8–11.6) |
| Nausea | 1 (1, 0.1–4.6) | 0 (0, 0–3) | 2 (2.7, 0.5–8.2) | 1 (1.3, 0.1–6.1) |
| Vomiting | 0 (0, 0–2.9) | 0 (0, 0–3) | 0 (0, 0–3.9) | 1 (1.3, 0.1–6.1) |
| Myalgia | 12 (11.9, 7–18.5) | 12 (12.2, 7.2–19.1) | 10 (13.3, 7.4–21.6) | 4 (5.3, 1.8–11.6) |
| Arthralgia | 2 (2, 0.4–6.1) | 4 (4.1, 1.4–9.1) | 4 (5.3, 1.8–11.8) | 1 (1.3, 0.1–6.1) |
| Fever (>38.0°C) | 0 (0, 0–2.9) | 0 (0, 0–3) | 0 (0, 0–3.9) | 0 (0, 0–3.9) |
a
CI, confidence interval.