GARDASIL 9: Package Insert and Label Information (Page 4 of 5)

14.5 Immune Responses to GARDASIL 9 Using a 2-Dose Regimen in Individuals 9 through 14 Years of Age

Effectiveness of GARDASIL 9 against persistent infection and disease related to vaccine HPV types in 9- through 14-year-old girls and boys who received a 2-dose regimen was inferred from non-inferiority comparison conducted in the PPI population in Study 8 of GMTs following vaccination with GARDASIL 9 among 9- through 14-year-old girls and boys who received a 2-dose regimen (at 0, 6 months or 0, 12 months) with those among 16- through 26-year-old girls and women who received a 3-dose regimen (at 0, 2, 6 months). Anti-HPV GMTs at one month after the last dose among 9- through 14-year-old girls and boys who received 2 doses of GARDASIL 9 were non-inferior to anti-HPV GMTs among 16- through 26-year-old girls and women who received 3 doses of GARDASIL 9 (Table 11).

One month following the last dose of the assigned regimen, between 97.9% and 100% of subjects across all groups became seropositive for antibodies against the 9 vaccine HPV types (Table 11).

In the same study, in girls and boys 9 through 14 years old, GMTs at one month after the last vaccine dose were numerically lower for some vaccine types after a 2-dose schedule than in girls 9 through 14 years old after a 3-dose schedule (HPV types 18, 31, 45, and 52 after 0, 6 months and HPV type 45 after 0, 12 months; Table 11). The clinical relevance of these findings is unknown.

Duration of immunity of a 2-dose schedule of GARDASIL 9 has not been established.

Table 11: Summary of Anti-HPV cLIA Geometric Mean Titers in the PPI * Population at One Month After the Last Vaccine Dose Among Subjects Who Received 2 Doses or 3 Doses of GARDASIL 9 (Study 8)
Population (Regimen) N n GMTmMU /mL GMT Ratio relative to 3-dose regimen in 16- through 26-year-old girls and women(95% CI)
N = Number of individuals randomized to the respective vaccination group who received at least 1 injection
n = Number of individuals contributing to the analysis
CI=Confidence Interval
cLIA=competitive Luminex Immunoassay
GMT=Geometric Mean Titer
*
The PPI population consisted of individuals who received all assigned vaccinations within pre-defined day ranges, did not have major deviations from the study protocol, met predefined criteria for the interval between the last vaccination dose and blood collection for immunogenicity assessment, and were seronegative to the relevant HPV type(s) (types 6, 11, 16, 18, 31, 33, 45, 52, and 58) prior to dose 1.
2-dose regimen (0, 6): vaccination at Day 1 and Month 6; 2-dose regimen (0, 12): vaccination at Day 1 and Month 12; 3-dose regimen (0, 2, 6): vaccination at Day 1, Month 2, and Month 6. The data are from Study 8 (NCT01984697).
mMU=milli-Merck Units
§
Demonstration of non-inferiority required that the lower bound of the 95% CI of the GMT ratio be greater than 0.67
Exploratory analysis; criterion for non-inferiority was not pre-specified
Anti-HPV 6
9- to 14-year-old girls (0, 6) 301 258 1657.9 2.15 (1.83, 2.53)§
9- to 14-year-old boys (0, 6) 301 263 1557.4 2.02 (1.73, 2.36)§
9- to 14-year-old girls and boys (0, 12) 300 257 2678.8 3.47 (2.93, 4.11)§
9- to 14-year-old girls (0, 2, 6) 300 254 1496.1 1.94 (1.65, 2.29)
16- to 26-year-old women (0, 2, 6) 314 238 770.9 1
Anti-HPV 11
9- to 14-year-old girls (0, 6) 301 258 1388.9 2.39 (2.03, 2.82)§
9- to 14-year-old boys (0, 6) 301 264 1423.9 2.45 (2.09, 2.88)§
9- to 14-year-old girls and boys (0, 12) 300 257 2941.8 5.07 (4.32, 5.94)§
9- to 14-year-old girls (0, 2, 6) 300 254 1306.3 2.25 (1.90, 2.66)
16- to 26-year-old women (0, 2, 6) 314 238 580.5 1
Anti-HPV 16
9- to 14-year-old girls (0, 6) 301 272 8004.9 2.54 (2.14, 3.00)§
9- to 14-year-old boys (0, 6) 301 273 8474.8 2.69 (2.29, 3.15)§
9- to 14-year-old girls and boys (0, 12) 300 264 14329.3 4.54 (3.84, 5.37)§
9- to 14-year-old girls (0, 2, 6) 300 269 6996.0 2.22 (1.89, 2.61)
16- to 26-year-old women (0, 2, 6) 314 249 3154.0 1
Anti-HPV 18
9- to 14-year-old girls (0, 6) 301 272 1872.8 2.46 (2.05, 2.96)§
9- to 14-year-old boys (0, 6) 301 272 1860.9 2.44 (2.04, 2.92)§
9- to 14-year-old girls and boys (0, 12) 300 266 2810.4 3.69 (3.06, 4.45)§
9- to 14-year-old girls (0, 2, 6) 300 270 2049.3 2.69 (2.24, 3.24)
16- to 26-year-old women (0, 2, 6) 314 267 761.5 1
Anti-HPV 31
9- to 14-year-old girls (0, 6) 301 272 1436.3 2.51 (2.10, 3.00)§
9- to 14-year-old boys (0, 6) 301 271 1498.2 2.62 (2.20, 3.12)§
9- to 14-year-old girls and boys (0, 12) 300 268 2117.5 3.70 (3.08, 4.45)§
9- to 14-year-old girls (0, 2, 6) 300 271 1748.3 3.06 (2.54, 3.67)
16- to 26-year-old women (0, 2, 6) 314 264 572.1 1
Anti-HPV 33
9- to 14-year-old girls (0, 6) 301 273 1030.0 2.96 (2.50, 3.50)§
9- to 14-year-old boys (0, 6) 301 271 1040.0 2.99 (2.55, 3.50)§
9- to 14-year-old girls and boys (0, 12) 300 269 2197.5 6.31 (5.36, 7.43)§
9- to 14-year-old girls (0, 2, 6) 300 275 796.4 2.29 (1.95, 2.68)
16- to 26-year-old women (0, 2, 6) 314 279 348.1 1
Anti-HPV 45
9- to 14-year-old girls (0, 6) 301 274 357.6 1.67 (1.38, 2.03)§
9- to 14-year-old boys (0, 6) 301 273 352.3 1.65 (1.37, 1.99)§
9- to 14-year-old girls and boys (0, 12) 300 268 417.7 1.96 (1.61, 2.37)§
9- to 14-year-old girls (0, 2, 6) 300 275 661.7 3.10 (2.54, 3.77)
16- to 26-year-old women (0, 2, 6) 314 280 213.6 1
Anti-HPV 52
9- to 14-year-old girls (0, 6) 301 272 581.1 1.60 (1.36, 1.87)§
9- to 14-year-old boys (0, 6) 301 273 640.4 1.76 (1.51, 2.05)§
9- to 14-year-old girls and boys (0, 12) 300 268 1123.4 3.08 (2.64, 3.61)§
9- to 14-year-old girls (0, 2, 6) 300 275 909.9 2.50 (2.12, 2.95)
16- to 26-year-old women (0, 2, 6) 314 271 364.2 1
Anti-HPV 58
9- to 14-year-old girls (0, 6) 301 270 1251.2 2.55 (2.15, 3.01)§
9- to 14-year-old boys (0, 6) 301 270 1325.7 2.70 (2.30, 3.16)§
9- to 14-year-old girls and boys (0, 12) 300 265 2444.6 4.98 (4.23, 5.86)§
9- to 14-year-old girls (0, 2, 6) 300 273 1229.3 2.50 (2.11, 2.97)
16- to 26-year-old women (0, 2, 6) 314 261 491.1 1

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