3). For all vaccines, most solicited reactions were generally mild or moderate and resolved within 3–7 days (data not shown). Injection-site reactions were reported by similar proportions of older adult subjects receiving the 15 μg (76.5%) or 21 μg (77.3%) ID vaccines, but they were reported more often VX 770 by subjects
immunized with the ID vaccines than by those receiving the HD (49.5%) or SD (34.5%) IM vaccines (Table 5). Among SD vaccine recipients, the Modulators proportion reporting injection-site reactions was higher for younger adults (64.3%) than for older adults (34.5%). The most common injection-site reaction reported with the ID vaccines was erythema, followed by induration, swelling, and pruritus, all of which were more common with the ID vaccines than with the IM vaccines (i.e. the SD and HD vaccines) (Fig. 4A). In contrast, injection-site pain was reported less often by older adults immunized with an ID vaccine than by older adults immunized with the HD vaccine or younger adults immunized with the SD vaccine. Grade-3 erythema
and swelling were reported more often by subjects immunized with an ID vaccine than by subjects immunized with an IM vaccine, although the proportions did not appear to differ between the 15 and 21 μg groups. The proportion of older adult subjects reporting solicited Anticancer Compound Library systemic reactions was similar for all vaccines, although myalgia (24.8%) was reported most often by those immunized with the HD vaccine (Fig. 4B). The proportions of subjects reporting myalgia, headache, and malaise were highest in younger adults receiving SD vaccine. One subject in three of the groups experienced an immediate unsolicited reaction (within 30 min of vaccination): only one older adult subject immunized with the 15 μg ID vaccine reported moderate dizziness lasting one day; one older adult subject immunized with SD vaccine reported moderate jaw pain lasting one day; and one young adult immunized with the SD reported a mild sore throat lasting eight days (Table 5). Only four subjects reported severe treatment-related unsolicited non-serious AEs. One older adult subject immunized with the 21 μg ID vaccine
reported a severe injection-site rash; one older adult subject immunized with the HD vaccine reported severe vomiting on the day of vaccination; one older adult subject immunized with the HD vaccine reported severe cough beginning 9 days after vaccination; and one younger adult immunized with the SD vaccine reported severe diarrhea and vomiting beginning on the day of vaccination. No treatment-related serious adverse events or treatment-related deaths occurred during the study. Vaccination acceptability was similar for all groups (Table 6). Although roughly two-thirds of the subjects in all groups reported feeling the needle puncture during vaccination, most of the subjects in each group reported experiencing “no pain” or “hardly any pain” (range: 77.6% [21 μg ID] to 86.2% [HD]).