Table 2.
Local and Systemic Solicited Adverse Events by Dose Group and Maximum Severity, All Ages Combined
| Dose Group | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Symptom | Severity | 1.35 × 105 (n = 18) | 2.7 × 105 (n = 19) | 4.5 × 105 (n = 24) | 9 × 105 (n = 27) | 1.8 × 106 (n = 24) | All Vaccine (n = 112) | After Dose 1 (9 × 105 and 1.8 × 106) (n = 51) | After Dose 2 (9 × 105 and 1.8 × 106) (n = 47) | Placebo (n = 53) |
| Any symptom | Mild | 5 (27.8) | 5 (26.3) | 4 (16.7) | 6 (22.2) | 10 (41.7) | 30 (26.8) | 12 (23.5) | 8 (17.0) | 18 (34.0) |
| Moderate | 2 (11.1) | 1 (5.3) | 2 (8.3) | 3 (11.1) | 2 (8.3) | 10 (8.9) | 3 (5.9) | 1 (2.1) | 4 (7.5) | |
| Severe | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
| Any systemic symptom | Mild | 4 (22.2) | 0 | 2 (8.3) | 2 (7.4) | 6 (25.0) | 14 (12.5) | 6 (11.8) | 3 (6.4) | 11 (20.8) |
| Moderate | 2 (11.1) | 0 | 1 (4.2) | 3 (11.1) | 1 (4.2) | 7 (6.3) | 3 (5.9) | 0 | 3 (5.7) | |
| Severe | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
| Allergic rash/urticaria/ generalized pruritusa | Mild | 2 (11.1) | 0 | 0 | 0 | 1 (4.2) | 3 (2.9) | 1 (2.0) | 0 | 3 (6.1) |
| Moderate | 0 | 0 | 0 | 1 (3.7) | 0 | 1 (1.0) | 1 (2.0) | 0 | 0 | |
| Severe | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
| Drowsiness | Mild | 0 | 0 | 0 | 1 (3.7) | 2 (8.3) | 3 (2.7) | 3 (5.9) | 0 | 3 (5.7) |
| Moderate | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
| Severe | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
| Irritability/fussiness | Mild | 1 (5.6) | 0 | 1 (4.2) | 1 (3.7) | 0 | 3 (2.7) | 1 (2.0) | 0 | 1 (1.9) |
| Moderate | 1 (5.6) | 0 | 0 | 1 (3.7) | 0 | 2 (1.8) | 1 (2.0) | 0 | 0 | |
| Severe | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
| Inability to eat | Moderate | 2 (11.1) | 0 | 1 (4.2) | 1 (3.7) | 1 (4.2) | 5 (4.5) | 2 (3.9) | 0 | 3 (5.7) |
| Severe | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
| Fever (axillary) | Mild | 2 (11.1) | 0 | 3 (12.5) | 3 (11.1) | 5 (20.8) | 13 (11.6) | 5 (9.8) | 3 (6.4) | 10 (18.9) |
| Moderate | 0 | 0 | 0 | 1 (3.7) | 0 | 1 (0.9) | 0 | 0 | 0 | |
| Severe | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
| Any local symptom | Mild | 1 (5.6) | 5 (26.3) | 2 (8.3) | 6 (22.2) | 6 (25.0) | 20 (17.9) | 7 (13.7) | 6 (12.8) | 11 (20.8) |
| Moderate | 0 | 1 (5.3) | 1 (4.2) | 0 | 1 (4.2) | 3 (2.7) | 0 | 1 (2.1) | 1 (1.9) | |
| Severe | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
| Pain at injection site | Mild | 1 (5.6) | 0 | 2 (8.3) | 3 (11.1) | 1 (4.2) | 7 (6.3) | 4 (7.8) | 0 | 5 (9.4) |
| Moderate | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 (1.9) | |
| Severe | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
| Pruritus/itchiness at injection sitea | Mild | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Moderate | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
| Severe | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
| Swelling at injection site | Mild | 0 | 5 (26.3) | 1 (4.2) | 4 (14.8) | 6 (25.0) | 16 (14.3) | 5 (9.8) | 6 (12.8) | 7 (13.2) |
| Moderate | 0 | 1 (5.3) | 0 | 0 | 1 (4.2) | 2 (1.8) | 0 | 1 (2.1) | 0 | |
| Severe | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
| Redness (erythema) at injection sitea | Mild | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 (2.0) |
| Moderate | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
| Severe | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
| Bruising at injection site | Mild | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Moderate | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
| Severe | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
| Induration at injection site | Mild | 0 | 0 | 0 | 0 | 1 (4.2) | 1 (0.9) | 0 | 1 (2.1) | 1 (1.9) |
| Moderate | 0 | 0 | 1 (4.2) | 0 | 0 | 1 (0.9) | 0 | 0 | 0 | |
| Severe | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
Only relevant age groups are included within each dose group; 1.35 × 105 and 2.7 × 105 groups include only 5- to 12-month-olds and 13- to 59-month-olds; other dose groups include all 3 age groups.
aAllergic rash/urticaria/generalized pruritus, pruritus/itchiness at injection site, and redness (erythema) at injection site were not collected for 5- to 9-year-olds receiving 4.5 × 105 or placebo.