TABLE 4.

Clinical AE summary (days 1 to 28 following any vaccination) by age group

Parametera50-59 yr of age (n = 389)≥60 yr of age (n = 731)
No. of subjects% of subjectsNo. of subjects% of subjects
Total389731
Subjects with follow-up38298.273099.9
Subjects with one or more AE23160.532344.2
    Injection-site AEs19350.525034.2
    Systemic AEs9625.113919.0
Subjects with vaccine-related AEsb19952.125635.1
    Injection-site AEsb19350.524934.1
    Systemic AEsb225.8212.9
Subjects with serious AEs10.350.7
    Serious vaccine-related AEs00.000.0
    Death00.000.0
Subjects who discontinued due to vaccine-related AE00.000.0
  • a The same subject may appear in different categories but is counted only once in each category.

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