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Gardasil
Clinical Pharmacology
Clinical Pharmacology
Gardasil
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
Generic Name: Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine
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