TABLE 1.
Local solicited symptoms reported during days 1 to 7d
| Local solicited symptom | No. (%) of patients |
|||||
|---|---|---|---|---|---|---|
| Placeboa (n = 108) | IIVb (n = 122) | RSV vaccine |
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| Cohort 4 (80 μg sF + 2.5 μg GLA; n = 20) | Cohort 1 (120 μg sF + 1 μg GLA; n = 39) | Cohort 2c (120 μg sF + 2.5 μg GLA; n = 78) | Cohort 3c (120 μg sF + 5 μg GLA; n = 78) | |||
| Any local solicited symptom | 27 (25.0) | 61 (50.0) | 8 (40.0) | 11 (28.2) | 38 (48.7) | 42 (53.8) |
| Tenderness or soreness at injection site | 21 (19.4) | 53 (43.4) | 7 (35.0) | 9 (23.1) | 33 (42.3) | 35 (44.9) |
| Pain at injection site | 18 (16.7) | 30 (24.6) | 6 (30.0) | 6 (15.4) | 22 (28.2) | 23 (29.5) |
| Swelling at injection site | 1 (0.9) | 3 (2.5) | 0 | 1 (2.6) | 1 (1.3) | 4 (5.1) |
| Redness at injection site | 1 (0.9) | 3 (2.5) | 0 | 1 (2.6) | 3 (3.8) | 0 |
a
The placebo group includes subjects who received placebo in the IIV plus placebo groups in cohorts 2 and 3.
b
The IIV group includes subjects who received IIV in cohort 1 and cohort 4 and IIV in the IIV plus placebo groups in cohorts 2 and 3.
c
In this cohort, subjects received the RSV vaccine plus the IIV or RSV vaccine plus placebo.
d
GLA, glucopyranosyl lipid A; IIV, inactivated influenza vaccine; RSV, respiratory syncytial virus; SE, stable emulsion; sF, soluble RSV fusion protein. One subject reported postdose swelling but did not report a measurement on days 4 and 5, so her highest severity grade could not be determined.