Table 5.
Overview of solicited AEs by age group: A, children aged 6 to <36 months; B, children aged 36 to <72 months and by vaccination status.*
| A. Children aged 6 to <36 months. | ||||||
|---|---|---|---|---|---|---|
| Naïve children | ||||||
| Vaccination | First |
Second |
Any |
|||
| Vaccine group | aTIV (n = 68) | TIV (n = 69) | aTIV (n = 67) | TIV (n = 67) | aTIV (n = 68) | TIV (n = 69) |
| Any, n (%) | 45 (66) | 35 (51) | 34 (51) | 28 (42) | 50 (74) | 41 (59) |
| Local | 35 (51) | 20 (29) | 21 (31) | 15 (22) | 38 (56) | 25 (36) |
| Systemic | 34 (50) | 27 (39) | 27 (40) | 22 (33) | 41 (60) | 32 (46) |
| Non-naïve children* | ||||||
| Vaccine group |
aTIV (n = 22) |
TIV (n = 22) |
||||
| Any, n (%) | 12 (55) | 9 (41) | ||||
| Local | 10 (45) | 7 (32) | ||||
| Systemic | 9 (41) | 7 (32) | ||||
| B. Children aged 36 to <72 months. | ||||||
| Naïve children | ||||||
| Vaccination | First |
Second |
Any |
|||
| Vaccine group |
aTIV (n = 6) |
TIV (n = 4) |
aTIV (n = 6) |
TIV (n = 3) |
aTIV (n = 6) |
TIV (n = 4) |
| Any, n (%) | 5 (83) | 2 (50) | 4 (67) | 2 (67) | 5 (83) | 3 (75) |
| Local | 5 (83) | 2 (50) | 4 (67) | 2 (67) | 5 (83) | 3 (75) |
| Systemic | 3 (50) | 1 (25) | 2 (33) | 0 | 4 (67) | 1 (25) |
| Non-naïve children* | ||||||
| Vaccine group |
aTIV (n = 44) |
TIV (n = 41) |
||||
| Any, n (%) | 22 (50) | 22 (54) | ||||
| Local | 17 (39) | 20 (49) | ||||
| Systemic | 15 (34) | 7 (17) | ||||
*
Non-naïve children received 1 vaccination.
Local reactions included: ecchymosis, erythema, induration, and swelling; and tenderness in children aged 6–<36 months; or pain in children 36–<72 months. Local reactions were categorized as: none (0 mm), any (≥1 mm).
Systemic reactions included: change in eating habits, vomiting, diarrhea, and fever ≥38°C; and in children aged 6–<36 months, sleepiness, persistent crying, irritability; and in children aged 36–<72 months, chills, myalgia, headache, and fatigue.
aTIV, adjuvanted trivalent influenza vaccine; TIV, trivalent influenza vaccine.