Table 2.
Day | Grade 0 | Grade 1 or 2 | Grade 3 | |||
---|---|---|---|---|---|---|
N | Mean Score | N | Mean Score | N | Mean Score | |
Baseline | 63 | 78.5 | 267 | 82.6 | 61 | 82.8 |
Day −7 pre-dose 1 | 63 | 75.6 | 267 | 82.0 | 61 | 82.6 |
Day 0 pre-dose 1 | 63 | 80.4 | 267 | 84.0 | 61 | 82.5 |
Day 60 pre-dose 2 | 63 | 79.6 | 266 | 81.9 | 61 | 83.4 |
Post-dose 2 (mean) | 61 | 82.5 | 267 | 81.9 | 61 | 80.4 |
Day 61 | 61 | 83.9 | 265 | 78.2 | 59 | 68.0 |
Day 62 | 61 | 82.6 | 265 | 81.5 | 59 | 78.9 |
Day 63 | 61 | 82.4 | 265 | 82.5 | 58 | 82.2 |
Day 64 | 61 | 82.0 | 265 | 82.8 | 59 | 82.8 |
Day 65 | 61 | 82.1 | 265 | 83.1 | 59 | 82.3 |
Day 66 | 60 | 81.8 | 265 | 83.2 | 59 | 82.6 |
Day 67a | 44 | 83.2 | 205 | 82.9 | 42 | 85.5 |
Notes: N = total number of participants; PF = physical functioning; SF-36 = Short Form Survey-36; high score represents high level of functioning/quality of life (maximum is 100). Baseline is calculated as the mean of Day −7, Day 0 (pre-dose 1), and Day 60 (pre-dose 2).
aVisit at Day 67: defined as 7-days post-dose 2; not all participants returned for the site visit exactly on Day 67. Reactogenicity grading: 0 (none/normal); 1 (mild); 2 (moderate); 3 (severe; prevents normal activity); for swelling/redness; greatest surface diameter 0 (<20 mm); 1 (≥20 mm–≤50 mm); 2(>50 mm–≤100 mm); 3 (>100 mm); for temperature: 0 (<37.5°C); 1 (37.5°C–38.0°C); 2 (38.1°C–39.0°C); 3 (>39.0°C).