TABLE 2

Summary of Anti-HPV cLIA Geometric Mean Titers (mMU/mL) Among Male and Female Subjects in the Long-term Follow-up Study (Per-Protocol Immunogenicity Populations)

TimeFemale SubjectsMale Subjects
nGMT95% CInGMT95% CI
A. HPV6
 Base study
  Day 1535<8<8–<8498<8<8–<8
  Month 7501893.9818.7–976.0456962.7874.2–1060.1
  Month 18491213.9195.7–233.8450224.5202.4–249.0
 LTFU study
  Month 42302122.6108.9–137.9252106.792.4–123.1
  Month 60227112.798.3–129.1201104.389.6–121.4
  Month 72258123.9110.4–139.0220114.199.1–131.5
  Month 8426888.678.3–100.222974.163.4–86.5
  Month 9624277.767.9–89.019763.253.9–74.0
B. HPV11
 Base study
  Day 1535<8<8–<8498<8<8–<8
  Month 75011356.81245.1–1478.64571370.81249.6–1503.8
  Month 18491304.1276.8–334.2451290.2261.8–321.7
 LTFU study
  Month 42302140.3123.3–159.6252127.5110.4–147.2
  Month 60227125.8108.0–146.5201118.1100.4–138.8
  Month 72258140.8122.9–161.2220132.8114.2–154.4
  Month 8426889.077.0–102.922980.167.6–95.0
  Month 9624272.761.8–85.519761.751.6–73.8
C. HPV16
 Base study
  Day 1534<12<12–<12498<12<12–<12
  Month 74974992.24501.9–5535.94566091.05447.0–6811.0
  Month 184871258.81142.1–1387.44501388.31238.8–1555.8
 LTFU study
  Month 42299597.1521.8–683.4253577.2484.5–687.7
  Month 60225464.7398.6–541.7199459.0380.8–553.3
  Month 72257523.0455.4–600.7219528.2443.3–629.4
  Month 84267401.4350.6–459.7228365.3302.4–441.3
  Month 96240353.0303.1–411.0196293.6240.5–358.4
D. HPV18
 Base study
  Day 1537<8<8–<8502<8<8–<8
  Month 75031130.81018.3–1255.74581470.71311.2–1649.5
  Month 18492181.4159.5–206.3452231.5199.8–268.2
 LTFU study
  Month 4230373.962.5–87.325590.573.6–111.1
  Month 6022756.346.4–68.420372.357.8–90.4
  Month 7225864.453.3–77.822282.266.0–102.4
  Month 8426945.438.5–53.623153.643.5–65.9
  Month 9624141.835.0–49.919942.834.5–53.2
  • CI, confidence interval; GMT, geometric mean titer; LTFU, long-term follow-up; mMU, milli Merck units.