Table 3.
Number and Percentage of Subjects Experiencing Any Solicited Events Following Any Vaccination
| Post Any Vaccination | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Group 1 3.75mcg+MF59 (D1-D29-D169) (N=79) | Group 2 3.75mcg+MF59 (D1-D57-D169) (N=79) | Group 3 7.5mcg+MF59 (D1-D29-D169) (N=82) | ||||||||||
| Symptom | N* | n | % | 95% CI | N* | n | % | 95% CI | N* | n | % | 95% CI |
| Any Symptom | 79 | 59 | 75 | 63.6, 83.8 | 79 | 60 | 76 | 65.0, 84.9 | 82 | 65 | 79 | 68.9, 87.4 |
| Any Systemic Symptom | 79 | 33 | 42 | 30.8, 53.4 | 79 | 34 | 43 | 31.9, 54.7 | 82 | 30 | 37 | 26.2, 48.0 |
| Elevated Oral Temperature | 79 | 3 | 4 | 0.8, 10.7 | 79 | 4 | 5 | 1.4, 12.5 | 82 | 3 | 4 | 0.8, 10.3 |
| Feverishness | 79 | 10 | 13 | 6.2, 22.0 | 79 | 6 | 8 | 2.8, 15.8 | 82 | 8 | 10 | 4.3, 18.3 |
| Fatigue | 79 | 20 | 25 | 16.2, 36.4 | 79 | 17 | 22 | 13.1, 32.2 | 82 | 16 | 20 | 11.6, 29.7 |
| Malaise | 79 | 8 | 10 | 4.5, 19.0 | 79 | 11 | 14 | 7.2, 23.5 | 82 | 18 | 22 | 13.6, 32.5 |
| Myalgia | 79 | 16 | 20 | 12.0, 30.8 | 79 | 21 | 27 | 17.3, 37.7 | 82 | 14 | 17 | 9.7, 27.0 |
| Arthralgia | 79 | 8 | 10 | 4.5, 19.0 | 79 | 8 | 10 | 4.5, 19.0 | 82 | 6 | 7 | 2.7, 15.2 |
| Headache | 79 | 12 | 15 | 8.1, 25.0 | 79 | 17 | 22 | 13.1, 32.2 | 82 | 14 | 17 | 9.7, 27.0 |
| Nausea | 79 | 3 | 4 | 0.8, 10.7 | 79 | 3 | 4 | 0.8, 10.7 | 82 | 6 | 7 | 2.7, 15.2 |
| Any Local Symptom | 79 | 52 | 66 | 54.3, 76.1 | 79 | 51 | 65 | 53.0, 75.0 | 82 | 57 | 70 | 58.4, 79.2 |
| Pain | 79 | 18 | 23 | 14.1, 33.6 | 79 | 30 | 38 | 27.3, 49.6 | 82 | 24 | 29 | 19.7, 40.4 |
| Tenderness | 79 | 42 | 53 | 41.6, 64.5 | 79 | 42 | 53 | 41.6, 64.5 | 82 | 49 | 60 | 48.3, 70.4 |
| Itching/Pruritus | 79 | 4 | 5 | 1.4, 12.5 | 79 | 3 | 4 | 0.8, 10.7 | 82 | 1 | 1 | 0.0, 6.6 |
| Ecchymosis/Bruising (functional grade) | 79 | 7 | 9 | 3.6, 17.4 | 79 | 8 | 10 | 4.5, 19.0 | 82 | 10 | 12 | 6.0, 21.3 |
| Ecchymosis/Bruising (measurement grade) | 79 | 7 | 9 | 3.6, 17.4 | 79 | 8 | 10 | 4.5, 19.0 | 82 | 10 | 12 | 6.0, 21.3 |
| Erythema/Redness (functional grade) | 79 | 19 | 24 | 15.1, 35.0 | 79 | 15 | 19 | 11.0, 29.4 | 82 | 24 | 29 | 19.7, 40.4 |
| Erythema/Redness (measurement grade) | 79 | 19 | 24 | 15.1, 35.0 | 79 | 15 | 19 | 11.0, 29.4 | 82 | 24 | 29 | 19.7, 40.4 |
| Induration/Swelling (functional grade) | 79 | 11 | 14 | 7.2, 23.5 | 79 | 16 | 20 | 12.0, 30.8 | 82 | 14 | 17 | 9.7, 27.0 |
| Induration/Swelling (measurement grade) | 79 | 11 | 14 | 7.2, 23.5 | 79 | 16 | 20 | 12.0, 30.8 | 82 | 14 | 17 | 9.7, 27.0 |
| Post Any Vaccination | ||||||||||||
| Group 4 7.5mcg+MF59 (D1-D57-D169) (N=79) | Group 5 15mcg+MF59 (D1-D29-D169) (N=79) | Group 6 15mcg+MF59 (D1-D57-D169) (N=79) | ||||||||||
| Symptom | N* | n | % | 95% CI | N* | n | % | 95% CI | N* | n | % | 95% CI |
| Any Symptom | 79 | 59 | 75 | 63.6, 83.8 | 79 | 59 | 75 | 63.6, 83.8 | 79 | 63 | 80 | 69.2, 88.0 |
| Any Systemic Symptom | 79 | 33 | 42 | 30.8, 53.4 | 79 | 34 | 43 | 31.9, 54.7 | 79 | 29 | 37 | 26.1, 48.3 |
| Elevated Oral Temperature | 79 | 1 | 1 | 0.0, 6.9 | 79 | 2 | 3 | 0.3, 8.8 | 79 | 5 | 6 | 2.1, 14.2 |
| Feverishness | 79 | 4 | 5 | 1.4, 12.5 | 79 | 8 | 10 | 4.5, 19.0 | 79 | 8 | 10 | 4.5, 19.0 |
| Post Any Vaccination | ||||||||||||
| Group 1 3.75mcg+MF59 (D1-D29-D169) (N=79) | Group 2 3.75mcg+MF59 (D1-D57-D169) (N=79) | Group 3 7.5mcg+MF59 (D1-D29-D169) (N=82) | ||||||||||
| Symptom | N* | n | % | 95% CI | N* | n | % | 95% CI | N* | n | % | 95% CI |
| Fatigue | 79 | 18 | 23 | 14.1, 33.6 | 79 | 16 | 20 | 12.0, 30.8 | 79 | 23 | 29 | 19.4, 40.4 |
| Malaise | 79 | 11 | 14 | 7.2, 23.5 | 79 | 13 | 16 | 9.1, 26.5 | 79 | 13 | 16 | 9.1, 26.5 |
| Myalgia | 79 | 11 | 14 | 7.2, 23.5 | 79 | 7 | 9 | 3.6, 17.4 | 79 | 13 | 16 | 9.1, 26.5 |
| Arthralgia | 79 | 10 | 13 | 6.2, 22.0 | 79 | 2 | 3 | 0.3, 8.8 | 79 | 4 | 5 | 1.4, 12.5 |
| Headache | 79 | 17 | 22 | 13.1, 32.2 | 79 | 8 | 10 | 4.5, 19.0 | 79 | 14 | 18 | 10.0, 27.9 |
| Nausea | 79 | 3 | 4 | 0.8, 10.7 | 79 | 3 | 4 | 0.8, 10.7 | 79 | 2 | 3 | 0.3, 8.8 |
| Any Local Symptom | 79 | 54 | 68 | 56.9, 78.4 | 79 | 50 | 63 | 51.7, 73.9 | 79 | 55 | 70 | 58.2, 79.5 |
| Pain | 79 | 22 | 28 | 18.3, 39.1 | 79 | 21 | 27 | 17.3, 37.7 | 79 | 22 | 28 | 18.3, 39.1 |
| Tenderness | 79 | 46 | 58 | 46.6, 69.2 | 79 | 42 | 53 | 41.6, 64.5 | 79 | 48 | 61 | 49.1, 71.6 |
| Itching/Pruritus | 79 | 3 | 4 | 0.8, 10.7 | 79 | 4 | 5 | 1.4, 12.5 | 79 | 3 | 4 | 0.8, 10.7 |
| Ecchymosis/Bruising (functional grade) | 79 | 6 | 8 | 2.8, 15.8 | 79 | 10 | 13 | 6.2, 22.0 | 79 | 9 | 11 | 5.3, 20.5 |
| Ecchymosis/Bruising (measurement grade) | 79 | 6 | 8 | 2.8, 15.8 | 79 | 10 | 13 | 6.2, 22.0 | 79 | 8 | 10 | 4.5, 19.0 |
| Erythema/Redness (functional grade) | 79 | 16 | 20 | 12.0, 30.8 | 79 | 17 | 22 | 13.1, 32.2 | 79 | 16 | 20 | 12.0, 30.8 |
| Erythema/Redness (measurement grade) | 79 | 16 | 20 | 12.0, 30.8 | 79 | 17 | 22 | 13.1, 32.2 | 79 | 16 | 20 | 12.0, 30.8 |
| Induration/Swelling (functional grade) | 79 | 15 | 19 | 11.0, 29.4 | 79 | 11 | 14 | 7.2, 23.5 | 79 | 17 | 22 | 13.1, 32.2 |
| Induration/Swelling (measurement grade) | 79 | 14 | 18 | 10.0, 27.9 | 79 | 11 | 14 | 7.2, 23.5 | 79 | 17 | 22 | 13.1, 32.2 |
N = Number of subjects in the Safety Analysis population. n = number of subjects reporting the specified symptom.
N* = Number of subjects with non-missing data for the specified symptom for at least one post-vaccination assessment; used as denominator for percentages and 95% CI calculations.
95% Confidence Intervals are from an exact binomial distribution (Clopper-Pearson).
*
one subject was randomized to Group 2, but followed the Group 1 schedule, so is counted under Group 1 for all safety and immunogenicity analysis populations