Table 4.
Age group specific percentages of participants experiencing injection site pain or tenderness and fever from 30 min through 7 days following each dose of study vaccines.
| 6 through 35 months of age |
36 through 71 months |
|||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Placebo |
TIV |
aTIV |
Placebo |
TIV |
aTIV |
|||||||
| n | % (95% CI) | n | % (95% CI) | n | % (95% CI) | n | % (95% CI) | n | % (95% CI) | n | % (95% CI) | |
| Post dose 1 | N = 39 | N = 79 | N = 78 | N = 20 | N = 40 | N = 40 | ||||||
| Fever | ||||||||||||
| 37.5–38.4 °C | 1 | 2.6 (0.1–13.5) | 9 | 11.4 (5.3–20.5) | 18 | 23.1 (14.3–34.0) | 3 | 15.0 (3.2–37.9) | 6 | 15.0 (5.7–29.8) | 12 | 30.0 (16.6–46.5) |
| 38.5–40.0 °C | 0 | 0.0 (0.0–9.0) | 0 | 0.0 (0.0–4.6) | 2 | 2.6 (0.3–9.0) | 0 | 0.0 (0.0–16.8) | 0 | 0.0 (0.0–8.8) | 1 | 2.5 (0.1–13.2) |
| >40.0 °C | 0 | 0.0 (0.0–9.0) | 0 | 0.0 (0.0–4.6) | 0 | 0.0 (0.0–4.6) | 0 | 0.0 (0.0–16.8) | 0 | 0.0 (0.0–8.8) | 0 | 0.0 (0.0–8.8) |
| Pain/tenderness* | ||||||||||||
| Mild or moderate | 9 | 23.1 (11.1–39.3) | 28 | 35.4 (25.0–47.0) | 32 | 41.0 (30.0–52.8) | 4 | 20.0 (5.7–43.7) | 9 | 22.5 (10.8–38.5) | 13 | 32.5 (18.6–49.1) |
| Severe | 0 | 0.0 (0.0–9.0) | 0 | 0.0 (0.0–4.6) | 0 | 0.0 (0.0–4.6) | 0 | 0.0 (0.0–16.8) | 0 | 0.0 (0.0–8.8) | 0 | 0.0 (0.0–8.8) |
| Post dose 2** | N = 35 | N = 68 | N = 73 | N = 18 | N = 37 | N = 39 | ||||||
| Fever | ||||||||||||
| 37.5–38.4 °C | 3 | 8.6 (1.8–23.1) | 9 | 13.2 (6.2–23.6) | 19 | 26.0 (16.5–37.6) | 1 | 5.6 (0.1–27.3) | 6 | 16.2 (6.2–32.0) | 9 | 23.1 (11.1–39.3) |
| 38.5 °C or higher | 1 | 2.9 (0.1–14.9) | 0 | 0.0 (0.0–5.3) | 3 | 4.1 (0.9–11.5) | 0 | 0.0 (0.0–18.5) | 0 | 0.0 (0.0–9.5) | 0 | 0.0 (0.0–9.0) |
| >40.0 °C | 0 | 0.0 (0.0–10.0) | 0 | 0.0 (0.0–5.3) | 0 | 0.0 (0.0–4.9) | 0 | 0.0 (0.0–18.5) | 0 | 0.0 (0.0–9.5) | 0 | 0.0 (0.0–9.0) |
| Pain/tenderness* | ||||||||||||
| Mild or moderate | 6 | 17.1 (6.6–33.7) | 13 | 19.1 (10.6–30.5) | 12 | 16.4 (8.8–27.0) | 0 | 0.0 (0.0–18.5) | 2 | 5.4 (0.7–18.2) | 3 | 7.7 (1.6–20.9) |
| Severe | 0 | 0.0 (0.0–10.0) | 0 | 0.0 (0.0–5.3) | 0 | 0.0 (0.0–4.9) | 0 | 0.0 (0.0–18.5) | 0 | 0.0 (0.0–9.5) | 0 | 0.0 (0.0–9.0) |
*
No other injection site reactions, including bruising, swelling, induration, or erythema, were identified in any child. Injection site pain/tenderness (pain without touching or tenderness as pain when the area is touched), was graded as follows: mild, pain/tenderness causing no or minimal limitation of use of limb; moderate, pain/tenderness limiting use of limb OR pain/tenderness causing greater than minimal interference with usual social and functional activities, severe, pain/tenderness causing inability to perform usual social and functional activities.