Table 7.
Numbers (%) of subjects with any (and severe/>100 mm) local reaction within 7 days after each vaccination (safety population)
| First vaccination | Second vaccination | Booster vaccination | |||||||||||
| Cohort 1 (9–17 years) | 3.75 μg +halfM F59 (n = 79 ) | 7.5 μg +fullM F59 (n = 79 ) | 3.75 μg +halfM F59 (n = 77 ) | 7.5 μg +fullM F59 (n = 78 ) | 3.75 μg +halfM F59 → trivalent seasonal MF59 vaccine (n = 23 ) | 7.5 μg +fullM F59 → trivalent seasonal MF59 vaccine (n = 24 ) | |||||||
| Ecchymosis | Any | 3 (4) | 5 (6) | 3 (4) | 2 (3) | 2 (9) | 0 | ||||||
| >100 mm | 0 | 0 | 0 | 0 | 0 | 0 | |||||||
| Erythema | Any | 6 (8) | 7 (9) | 4 (5) | 10 (13) | 2 (9) | 3 (13) | ||||||
| >100 mm | 0 | 0 | 0 | 0 | 0 | 0 | |||||||
| Induration | Any | 9 (11) | 12 (15) | 7 (9) | 5 (6) | 5 (22) | 3 (13) | ||||||
| >100 mm | 0 | 0 | 0 | 0 | 0 | 0 | |||||||
| Swelling | Any | 5 (6) | 10 (13) | 4 (5) | 7 (9) | 0 | 4 (17) | ||||||
| >100 mm | 0 | 0 | 0 | 0 | 0 | 0 | |||||||
| Pain | Any | 54 (68) | 65 (82) | 42 (55) | 43 (55) | 17 (74) | 19 (79) | ||||||
| Severe | 0 | 1 (1) | 0 | 1 (1) | 3 (13) | 2 (8) | |||||||
| Cohort 2 (3–8 years) | First vaccination | Second vaccination | Booster vaccination | Second seasonal vaccination | |||||||||
| 3.75 μg +halfMF59 (n = 70 ) | 7.5 μg +fullMF59 (n = 72 ) | 15 μg +noMF59 (n = 39 ) | 3.75 μg +halfMF59 (n = 70 ) | 7.5 μg +fullMF59 (n = 70 ) | 15 μg +noMF59 (n = 36 ) | 3.75 μg +halfMF59 → trivalent seasonal MF59 vaccine (n = 30 ) | 7.5 μg +fullMF59 → trivalent seasonal MF59 vaccine (n = 35 ) | 15 μg +noMF59 → trivalent seasonal MF59 vaccine (n = 14 ) | 3.75 μg +halfMF59 → 2× trivalent seasonal MF59 vaccine (n = 22 ) | 7.5 μg +fullMF59 → 2× trivalent seasonal MF59 vaccine (n = 26 ) | 15 μg +noMF59 → 2× trivalent seasonal MF59 vaccine (n = 11 ) | ||
| Ecchymosis | Any | 4 (6) | 6 (8) | 7 (18) | 6 (9) | 5 (7) | 4 (11) | 1 (3) | 1 (3) | 0 | 0 | 1 (4) | 0 |
| >100 mm | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
| Erythema | Any | 11 (16) | 14 (19) | 7 (18) | 7 (10) | 14 (20) | 3 (8) | 8 (27) | 5 (14) | 0 | 4 (18) | 6 (23) | 0 |
| >100 mm | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
| Induration | Any | 6 (9) | 11 (15) | 3 (8) | 4 (6) | 10 (14) | 3 (8) | 4 (13) | 5 (14) | 0 | 4 (18) | 7 (27) | 0 |
| >100 mm | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
| Swelling | Any | 5 (7) | 7 (10) | 2 (5) | 5 (7) | 5 (7) | 2 (6) | 3 (10) | 5 (14) | 1 (7) | 4 (18) | 5 (19) | 1 (9) |
| >100 mm | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
| Pain | Any | 30 (43) | 33 (46) | 14 (36) | 26/69 (38) | 30 (43) | 10 (28) | 23 (77) | 24 (69) | 9 (64) | 13 (59) | 13 (50) | 7 (64) |
| Severe | 1 (1) | 2 (3) | 0 | 1/69 (1) | 0 | 0 | 1 (3) | 1 (3) | 0 | 0 | 1 (4) | 0 | |
| Cohort 3 (1–<3 years) | First vaccination | Second vaccination | First booster vaccination | Second seasonal vaccination | |||||||||
| 3.75 μg +halfMF59 (n = 65 ) | 7.5 μg +fullMF59 (n = 73 ) | 15 μg +noMF59 (n = 33 ) | 3.75 μg +halfMF59 (n = 64 ) | 7.5 μg +fullMF59 (n = 71 ) | 15 μg +noMF59 (n = 29 ) | 3.75 μg +halfMF59 → trivalent seasonal MF59 vaccine (n = 42 ) | 7.5 μg +fullMF59 → trivalent seasonal MF59 vaccine (n = 51 ) | 15 μg +noMF59 → trivalent seasonal MF59 vaccine n = 21 ) | 3.75 μg +halfMF59 → 2× trivalent seasonal MF59 vaccine (n = 36 ) | 7.5 μg +fullMF59 → 2× trivalent seasonal MF59 vaccine (n = 45 ) | 15 μg +noMF59 → 2× trivalent seasonal MF59 vaccine n = 17 ) | ||
| Ecchymosis (mm) | Any | 3 (5) | 8 (11) | 5 (15) | 1 (2) | 5 (7) | 2 (7) | 2 (5) | 5 (10) | 0 | 0 | 1 (2) | 1 (6) |
| >100 mm | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
| Erythema (mm) | Any | 8 (12) | 12 (16) | 6 (18) | 6 (9) | 11 (15) | 4 (14) | 6 (14) | 13 (25) | 4 (19) | 10 (28) | 10 (22) | 2 (12) |
| >100 mm | 0 | 0 | 0 | 0 | 1 (1) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
| Induration (mm) | Any | 6 (9) | 10 (14) | 3 (9) | 2 (3) | 4 (6) | 2 (7) | 4 (10) | 7 (14) | 3 (14) | 8 (22) | 8 (18) | 3 (18) |
| >100 mm | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
| Swelling (mm) | Any | 1 (2) | 4 (5) | 2 (6) | 1 (2) | 4 (6) | 1 (3) | 6 (14) | 4 (8) | 1 (5) | 7 (19) | 7 (16) | 2 (12) |
| >100 mm | 0 | 1 (1) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
| Tenderness | Any | 7 (11) | 30 (41) | 10 (30) | 5 (8) | 21 (30) | 9 (31) | 8 (19) | 18 (35) | 7 (33) | 8 (22) | 11 (24) | 4 (24) |
| Cried when injected limb was moved | 0 | 3 (4) | 1 (3) | 0 | 1 (1) | 0 | 1 (2) | 0 | 0 | 0 | 0 | 1 (6) | |
| Cohort 4 (6–11 months) | First vaccination | Second vaccination | Booster vaccination | Booster vaccination | |||||||||
| 3.75 μg +halfMF59 (n = 75 ) | 7.5 μg +fullMF59 (n = 74 ) | 3.75 μg +halfMF59 (n = 71 ) | 7.5 μg +fullMF59 (n = 70 ) | 3.75 μg +halfMF59 → trivalent seasonal MF59 vaccine (n = 67 ) | 7.5 μg +fullMF59 → trivalent seasonal MF59 vaccine (n = 61 ) | 3.75 μg +halfMF59 → 2× trivalent seasonal MF59 vaccine (n = 63 ) | 7.5 μg +fullMF59 → 2× trivalent seasonal MF59 vaccine (n = 60 ) | ||||||
| Ecchymosis (mm) | Any | 2 (3) | 0 | 3 (4) | 0 | 1 (1) | 1 (2) | 1 (2) | 1 (2) | ||||
| >100 mm | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |||||
| Erythema (mm) | Any | 6 (8) | 5 (7) | 9 (13) | 3 (4) | 5 (7) | 9 (15) | 6 (10) | 6 (10) | ||||
| >100 mm | 0 | 0 | 0 | 0 | 0 | 1 (2) | 0 | 0 | |||||
| Induration (mm) | Any | 4 (5) | 3 (4) | 3 (4) | 7 (10) | 5 (7) | 4 (7) | 6 (10) | 5 (8) | ||||
| >100 mm | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |||||
| Swelling (mm) | Any | 0 | 0 | 1 (1) | 0 | 1 (1) | 5 (8) | 3 (5) | 3 (5) | ||||
| >100 mm | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |||||
| Tenderness | Any | 9 (12) | 17 (23) | 12 (17) | 18 (26) | 11 (16) | 19 (31) | 14 (22) | 13 (22) | ||||
| Cried when injected limb was moved | 0 | 2 (3) | 0 | 1 (1) | 2 (3) | 2 (3) | 2 (3) | 3 (5) | |||||