TABLE 10

Injection-Site AEs Prompted for on the VRC

Concomitant (Group A)aNonconcomitant (Group B)a% Difference Group A vs Group B (95% CI)P
9vHPV injection site (reported d 1–5 postdose 1)
 Subjects contributing to the analysis, n611609
  Erythema, n (%)61 (10.0)54 (8.9)1.1 (–2.2 to 4.4).505
  Pain, n (%)356 (58.3)335 (55.0)3.3 (–2.3 to 8.8).251
  Swelling, n (%)88 (14.4)57 (9.4)5.0 (1.4 to 8.7).007
MCV4 and Tdap injection site (reported d 1–5 postvaccination)
 Subjects contributing to the analysis, n611598
  Erythema, n (%)159 (26.0)152 (25.4)0.6 (–4.3 to 5.5).810
  Pain, n (%)439 (71.8)406 (67.9)4.0 (–1.2 to 9.1).134
  Swelling, n (%)188 (30.8)174 (29.1)1.7 (–3.5 to 6.8).526
  • All subjects who received ≥1 injection and had follow-up data were included in the primary analysis of safety. The number and percent of subjects reporting injection-site AEs were compared between Group A and Group B. Risk differences, 95% CIs and P values were calculated for injection site AEs between day 1 and day 5 for both groups. CI, confidence interval.

  • a Group A (concomitant administration) received a 0.5-mL dose of 9vHPV vaccine at day 1, month 2, and month 6 and a 0.5-mL dose of MCV4 and Tdap on day 1; Group B (nonconcomitant administration) received 9vHPV vaccine as Group A and MCV4 and Tdap at month 1. Two subjects randomized into the nonconcomitant group received 9vHPV vaccine at day 1 but did not did not receive MCV4 and Tdap at month 1 and are excluded from this table.