GARDASIL was efficacious against HPV disease caused by each of the 4 vaccine HPV types.

In a pre-defined analysis, the efficacy of GARDASIL against HPV 16/18-related disease was 100% (95% CI: 87.9%, 100.0%) for CIN 3 or AIS and 100% (95% CI: 55.5%, 100.0%) for VIN 2/3 or VaIN 2/3. The efficacy of GARDASIL against HPV 6-, 11-, 16-, and 18-related VIN 1 or VaIN 1 was 100% (95% CI: 75.8%, 100.0%). These analyses were conducted in the PPE population that consisted of individuals who received all 3 vaccinations within 1 year of enrollment, did not have major deviations from the study protocol, and were naïve (PCR negative and seronegative) to the relevant HPV type(s) (Types 6, 11, 16, and 18) prior to dose 1 and through 1 month Postdose 3 (Month 7).

GARDASIL is a prophylactic vaccine.

There was no clear evidence of protection from disease caused by HPV types for which subjects were PCR positive and/or seropositive at baseline.

Individuals who were already infected with 1 or more vaccine-related HPV types prior to vaccination were protected from clinical disease caused by the remaining vaccine HPV types.

The general population of young American women includes women who are HPV-naïve (PCR negative and seronegative) and women who are HPV-non-naïve (PCR positive and/or seropositive), some of whom have HPV-related disease. The clinical trials population approximated the general population of American women with respect to prevalence of HPV infection and disease at enrollment. Analyses were conducted to evaluate the overall impact of GARDASIL with respect to HPV 6-, 11-, 16-, and 18-related cervical and genital disease in the general population. Here, analyses included events arising from HPV infections that were present at the start of vaccination as well as events that arose from infections that were acquired after the start of vaccination.

The impact of GARDASIL in the general population is shown in Table 2. Impact was measured starting 1 month Postdose 1. Prophylactic efficacy denotes the vaccines efficacy in women who are naïve (PCR negative and seronegative) to the relevant HPV types at vaccination onset. General population impact denotes vaccine impact among women regardless of baseline PCR status and serostatus. The majority of CIN and genital warts, VIN, and VaIN detected in the group that received GARDASIL occurred as a consequence of HPV infection with the relevant HPV type that was already present at Day 1.

Table 2
General Population Impact for Vaccine HPV Types

Bookmark this page: