TABLE 5

Summary of Injection-Site AEs Reported During Days 1 to 5 Postdose 1, 2, and 3 and Across All Vaccinations, in All Participants Who Received at Least 1 Injection of Vaccine

Injection Site AEGirls (10–15 y old), n (%)aBoys (10–15 y old), n (%)aWomen (16–23 y old), n (%)a
Pain/tenderness/soreness
    No. of participants who reported
        Postdose 1300 (59.9)265 (53.0)321 (64.6)
        Postdose 2276 (55.4)211 (42.6)296 (61.4)
        Postdose 3288 (58.8)185 (38.1)295 (63.6)
        Across all vaccinations398 (79.4)357 (71.4)429 (86.3)
        P.004b<.001b
    Total no. of times this AE was reported896686953
    Intensity of AEsc
        Mild712 (79.5)576 (84.0)736 (77.2)
        Moderate166 (18.5)104 (15.2)206 (21.6)
        Severe17 (1.9)6 (0.9)10 (1.0)
Redness (erythema)
    No. of participants who reported
        Postdose 134 (6.8)31 (6.2)48 (9.7)
        Postdose 252 (10.4)35 (7.1)50 (10.4)
        Postdose 363 (12.9)50 (10.3)69 (14.9)
        Across all vaccinations101 (20.2)93 (18.6)130 (26.2)
        P.025b.004b
    Total No. of times this AE was reported149118170
    Intensity of AEsc
        Mild133 (89.3)101 (85.6)143 (84.1)
        Moderate14 (9.4)11 (9.3)16 (9.4)
        Severe2 (1.3)4 (3.4)5 (2.9)
Injection-site swelling
    No. of participants who reported
        Postdose 139 (7.8)27 (5.4)48 (9.7)
        Postdose 269 (13.9)50 (10.1)63 (13.1)
        Postdose 373 (14.9)59 (12.1)66 (14.2)
        Across all vaccinations127 (25.3)107 (21.4)125 (25.2)
        P.943b.161b
    Total No. of times this AE was reported188138190
    Intensity of AEsc
        Mild136 (72.3)103 (74.6)151 (79.5)
        Moderate43 (22.9)23 (16.7)24 (12.6)
        Severe9 (4.8)11 (8.0)9 (4.7)
  • a Percentages were calculated on the basis of the number of participants with follow-up (see Table 4 for denominators).

  • b P value for comparison with the proportion of 16- to 23-year-old females with the specific injection-site AE, unadjusted for multiple comparisons.

  • c Percentages were calculated as 100 × (No. of AEs of specific intensity/total AEs reported). Not all column percentages add up to 100% because the intensity ratings for some AEs were unknown.