TABLE 2

Summary of Clinical and Specific Systemic Adverse Experiences During Days 1 to 43 After Vaccination

Subjects WithProportion, %
ProQuad + Placebo (Group 1) (N = 399, n = 397)M-M-RII + Placebo (Group 2) (N = 205, n = 205)M-M-RII + Varivax (Group 3) (N = 195, n = 193)
One or more adverse experiences77.678.075.6
Injection-site adverse experiences56.250.751.3
Systemic adverse experiencesa54.760.059.1
    Elevated temperature (≥102°F oral equivalent or abnormal)b10.29.99.4
    Nasopharyngitisc13.112.713.5
    Coughc12.88.810.9
  • Percentages are based on the number of subjects with the adverse experience of the total number of subjects with available safety follow-up information. N indicates the number of subjects vaccinated; n indicates the number of subjects with safety follow-up data.

  • a Occurring at an incidence rate of ≥10%.

  • b None of the P values for the risk comparisons between group 1 and group 2 or between group 1 and group 3 showed statistical significance.

  • c The P values for the risk comparisons between group 1 and group 2 and between group 1 and group 3 were not calculated for nonsolicited adverse experiences; however, all of the 95% CIs for these risk comparisons contained 0, which demonstrated that the groups were comparable.