TABLE 3

Proportions of Subjects (≥3%) With Specific Injection-Site Adverse Experiences at Each Injection Site During Days 1 to 5 After Vaccination

Subjects WithProportion, %
ProQuad + Placebo (Group 1) (N = 399, n = 397), ProQuad SiteM-M-RII + Placebo (Group 2) (N = 205, n = 205), M-M-RII SiteM-M-RII + Varivax (Group 3) (N = 195, n = 193)
M-M-RII SiteVarivax SiteM-M-RII + Varivax Sitesa
Pain/tenderness/soreness41.136.635.236.844.6
    Mild87.184.091.285.9NA
Erythema24.415.614.515.522.8
    ≤1 inch80.490.682.166.7NA
Swelling15.610.27.810.915.0
    ≤1 inch75.881.086.761.9NA
  • 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; NA, not available because no analysis was planned. The risk differences for the following comparisons showed statistically significant differences: erythema for ProQuad versus M-M-RII in group 2 (risk difference: 8.8; P = .012) and group 3 (risk difference: 9.9; P = .006) and Varivax (risk difference: 8.9; P = .014) and swelling for ProQuad versus M-M-RII in group 3 (risk difference: 7.8; P = .008).

  • a When the data for recipients of M-M-RII and Varivax were combined, an injection-site adverse experience was counted only once, regardless of whether it was reported at the injection site for 1 or both vaccines.