TABLE 2.

AEs following one dose of either the Zostavax frozen or the Zostavax refrigerated formulation, day 1 to day 28 postvaccination

GroupNo. (%) of subjectsa
Refrigerated group (n = 182)Frozen group (n = 185)
All subjects182185
Subjects with follow-up180 (98.9)183 (98.9)
Subjects with one or more AEs82 (45.6)101 (55.2)
    Injection-site AEsb,c64 (35.6)85 (46.4)
    Systemic AEs34 (18.9)39 (21.3)
Subjects with vaccine-related AEsc68 (37.8)87 (47.5)
    Injection-site AEsc64 (35.6)85 (46.4)
    Systemic AEsc10 (5.6)11 (6.0)
Subjects with serious AEs1 (0.6)0 (0.0)
    Vaccine-related serious AEs0 (0.0)0 (0.0)
    Death0 (0.0)0 (0.0)
Subjects who discontinued due to any AE0 (0.0)0 (0.0)
Subjects who discontinued due to a vaccine-related AE0 (0.0)0 (0.0)
  • a The same subject may appear in different categories but is counted only once in each category.

  • b All injection-site AEs were considered vaccine related.

  • c Determined by the investigator to be possibly, probably, or definitely related to the vaccine.