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Gardasil

Clinical Pharmacology
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Clinical Pharmacology

Table 4 compares anti-HPV GMTs 1 month Postdose 3 among subjects who received Dose 2 between Month 1 and Month 3 and subjects who received Dose 3 between Month 4 and Month 8 (Table 4).

Table 4
Summary of GMTs for Variation of Dosing Regimen

Variation of Dosing Regimen
Anti-HPV 6
Anti-HPV 11
  Anti-HPV 16
Anti-HPV 18
N
GMT
(95% CI)
N
GMT
(95% CI)
N
GMT
(95% CI)
N
GMT
(95% CI)
Dose 2
Early*
883
570.9
(542.2, 601.2)
888
824.6
(776.7, 875.5)
854
2625.3
(2415.1, 2853.9)
926
517.7
(482.9, 555.0)
On Time*
1767
552.3
(532.3, 573.1)
1785
739.7
(709.3, 771.5)
1737
2400.0
(2263.9, 2544.3)
1894
473.9
(451.8, 497.1)
Late*
313
447.4
(405.3, 493.8)
312
613.9
(550.8, 684.2)
285
1889.7
(1624.4, 2198.5)
334
388.5
(348.3, 433.3)
Dose 3
Early**
495
493.1
(460.8, 527.8)
501
658.9
(609.5, 712.2)
487
2176.6
(1953.4, 2425.3)
521
423.4
(388.8, 461.2)
On Time**
2081
549.6
(531.1, 568.8)
2093
752.8
(723.8, 782.9)
2015
2415.0
(2286.3, 2550.9)
2214
486.0
(464.7, 508.2)
Late**
335
589.0
(537.0, 645.9)
339
865.3
(782.6, 956.7)
326
2765.9
(2408.7, 3176.2)
361
498.5
(446.2, 557.0)
*Early = 36 to 50 days Postdose 1; On-Time = 51 to 70 days Postdose 1; Late = 71 to 84 days Postdose 1.
**Early = 80 to 105 days Postdose 2; On-Time = 106 to 137 days Postdose 2; Late = 138 to 160 days Postdose 2.
Note: GMT = Geometric mean titer in mMU/mL (mMU = milli-Merck units.)
Brand Name: Gardasil
Generic Name: Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine
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