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Studies assessed efficacy of GARDASIL in the general population of women

The studies also assessed the efficacy of GARDASIL in the general population of women, including those infected with HPV (and who may have had HPV-related disease) at the start of the trials. In FUTURE I, GARDASIL reduced the rate of cervical lesions caused by vaccine or other HPV types by 20 percent; 344 cases were observed in the vaccine group (n= 2,723); 421 cases were observed in the placebo group (n=2,732). GARDASIL reduced the rate of vaginal or vulvar lesions and genital warts caused by vaccine or other HPV types by 34 percent; 104 cases were observed in the vaccine group (n= 2,723); 157 cases were observed in the placebo group (n=2,732). In FUTURE II, vaccination with GARDASIL reduced the rate of CIN 2/3 and AIS caused by vaccine or other HPV types by 17 percent; 219 cases were observed in the vaccine group (n= 6,087); 266 cases were observed in the placebo group (n=6,080). In both studies, the majority of lesions occurred among women who were already HPV-infected at the start of vaccination. Vaccination with GARDASIL did not change the course of these pre-existing infections. Infections present at the start of vaccination caused most of the lesions in the early period of follow-up; however, over three years, the impact of the vaccine became more apparent, as lesions caused by new infections with vaccine HPV types were observed in the placebo group but not in the vaccine group.

In both studies, the adverse events observed were similar to what has been previously reported.

Additional important information about GARDASIL

The health-care provider should inform the patient, parent or guardian that vaccination does not substitute for routine cervical cancer screening. Women who receive GARDASIL should continue to undergo cervical cancer screening per standard of care.

Vaccination with GARDA
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