![]() Table 1: Injection-Site Adverse Reactions Reported in ≥1% of Adults Who Received ZOSTAVAX or Placebo Within 5 Days Postvaccination in the ZOSTAVAX Efficacy and Safety Trial * Solicited on the Vaccination Report Card ![]() Injection-site adverse reactions occurring at an incidence ≥1% within 5 days postvaccination are shown in Table 1. The overall incidence of vaccine-related injection-site adverse reactions within 5 days postvaccination was greater for subjects vaccinated with ZOSTAVAX as compared to subjects who received placebo (63.6% for ZOSTAVAX and 14.0% for placebo). Most Common Adverse Reactions and Experiences in the ZEST Study An anaphylactic reaction was reported for one subject vaccinated with ZOSTAVAX. ![]() In the ZEST study, all subjects were monitored for adverse reactions. In the ZEST study, serious adverse events occurred at a similar rate in subjects vaccinated with ZOSTAVAX (0.6%) or placebo (0.5%) from Days 1 to 42 postvaccination. All subjects received a vaccination report card (VRC) to record adverse events occurring from Days 1 to 42 postvaccination. The age distribution of subjects enrolled, 50 to 59 years, was similar in both vaccination groups. The gender distribution was 38% male and 62% female in both vaccination groups. The racial distribution across both vaccination groups was similar: White (94.4%) Black (4.2%) Hispanic (3.3%) and Other (1.4%) in both vaccination groups. In the ZEST study, subjects received a single dose of either ZOSTAVAX (N=11,184) or placebo (N=11,212). ZOSTAVAX Efficacy and Safety Trial (ZEST) in Subjects 50 to 59 Years of Age Because clinical trials are conducted under widely varying conditions, rates of adverse reactions observed in the clinical trials of a vaccine cannot be directly compared to rates in the clinical trials of another vaccine and may not reflect the rates observed in practice.
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