TABLE 1

Local solicited symptoms reported during days 1 to 7d

Local solicited symptomNo. (%) of patients
Placeboa (n = 108)IIVb (n = 122)RSV vaccine
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 symptom27 (25.0)61 (50.0)8 (40.0)11 (28.2)38 (48.7)42 (53.8)
Tenderness or soreness at injection site21 (19.4)53 (43.4)7 (35.0)9 (23.1)33 (42.3)35 (44.9)
Pain at injection site18 (16.7)30 (24.6)6 (30.0)6 (15.4)22 (28.2)23 (29.5)
Swelling at injection site1 (0.9)3 (2.5)01 (2.6)1 (1.3)4 (5.1)
Redness at injection site1 (0.9)3 (2.5)01 (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.