Table 3.
Symptoms | 23vPPV (n=2340) | Saline placebo (n=2332) | ||||
|
Female (n=1138), n (%) | Male (n=1202), n (%) | P value | Female (n=1139), n (%) | Male (n=1193), n (%) | P value |
Any symptom | 433 (38.05) | 372 (30.95) | <.001 | 141(12.38) | 99 (8.30) | .001 |
Any local symptoms | 363 (31.90) | 297 (24.71) | <.001 | 36 (3.16) | 23 (1.93) | .06 |
Redness at injection site | 89 (7.82) | 57 (4.74) | .002 | 10 (0.88) | 2 (0.17) | .02 |
Swelling at injection site | 120 (10.54) | 87 (7.24) | .005 | 10 (0.88) | 2 (0.17) | .02 |
Pain at injection site | 321 (28.21) | 266 (22.13) | .001 | 28 (2.46) | 21 (1.76) | .24 |
Limited arm movement | 157 (13.80) | 67 (5.57) | <.001 | 8 (0.70) | 3 (0.25) | .11 |
Any systemic symptom | 236 (20.74) | 201 (16.72) | .01 | 105 (9.22) | 75 (6.29) | .008 |
Fever (reported) | 31 (2.72) | 50 (4.16) | .06 | 23 (2.02) | 31 (2.60) | .35 |
Fatigue | 109 (9.58) | 90 (7.49) | .07 | 64 (5.62) | 39 (3.27) | .01 |
Headache | 97 (8.52) | 75 (6.24) | .03 | 63 (5.53) | 35 (2.93) | .002 |
Chills | 30 (2.64) | 26 (2.16) | .45 | 18 (1.58) | 12 (1.01) | .22 |
Rash | 23 (2.02) | 8 (0.67) | .004 | 1 (0.09) | 2 (0.17) | .59 |
Extensive arm swellinga | 10 (0.88) | 3 (0.25) | .04 | 0 (0.00) | 0 (0.00) |
|
Generalized muscle pain | 114 (10.02) | 103 (8.57) | .23 | 48 (4.21) | 16 (1.34) | <.001 |
Generalized joint pain | 29 (2.55) | 21 (1.75) | .18 | 21 (1.84) | 11 (0.92) | .056 |
aDescribed as elbow joint to shoulder joint.