TABLE 5

Seroconversion Rates and Estimated Percent Difference at 4 Weeks After Dose 3 in the HPV Per-Protocol Populations

AntigenConcomitant (Group A),aN = 619Nonconcomitant (Group B),aN = 618Estimated Percent Difference Group A – Group Bb (95% confidence interval)
m/nResponse (%)m/nResponse (%)
HPV6501/501100514/5141000.0 (–0.8 to 0.7)
HPV11502/502100514/5141000.0 (–0.8 to 0.7)
HPV16513/513100530/5301000.0 (–0.7 to 0.7)
HPV18516/516100535/5351000.0 (–0.7 to 0.7)
HPV31514/514100536/5361000.0 (–0.7 to 0.7)
HPV33520/520100537/5371000.0 (–0.7 to 0.7)
HPV45523/523100539/5391000.0 (–0.7 to 0.7)
HPV52521/521100538/5381000.0 (–0.7 to 0.7)
HPV58519/519100537/5371000.0 (–0.7 to 0.7)
  • m = number of subjects with the indicated response; N, number of subjects randomized to the respective vaccination group who received at least 1 injection; n, number of subjects contributing to the analysis. Seropositive is defined as anti-HPV serum levels (assessed by competitive Luminex immunoassay) greater or equal to 30, 16, 20, 24, 10, 8, 8, 8, 8 milliMerck units/mL for HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58, respectively.

  • a Group A (concomitant administration) received a 0.5-mL dose of 9vHPV vaccine at day 1, month 2, and month 6 and MCV4 and Tdap on day 1; Group B (nonconcomitant administration) received 9vHPV vaccine as Group A and MCV4 and Tdap at month 1.

  • b P value for noninferiority <.001 for all 9 antigens. The noninferiority criterion for seroconversion end points reported in this table was defined as statistically <5 percentage points decrease in Group A compared with Group B. Noninferiority of seroconversion rates in Group A relative to Group B was demonstrated if the lower limit of the 95% confidence interval for the percentage point difference was greater than –5.