Vaccine Information: GARDASIL (Page 5 of 8)

14.5 Population Impact in Boys and Men 16 through 26 Years of Age

Effectiveness of GARDASIL in Prevention of HPV Types 6-, 11-, 16-, or 18-Related Anogenital Disease in Boys and Men 16 Through 26 Years of Age, Regardless of Current or Prior Exposure to Vaccine HPV Types

Study 5 included boys and men regardless of current or prior exposure to vaccine HPV types, and additional analyses were conducted to evaluate the impact of GARDASIL with respect to HPV 6-, 11-, 16-, and 18-related anogenital disease in these boys and men. Here, analyses included events arising among boys and men regardless of baseline PCR status and serostatus, including 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 boys and men regardless of current or prior exposure to a vaccine HPV type is shown in Table 16. Impact was measured starting at Day 1. Prophylactic efficacy denotes the vaccine’s efficacy in boys and men who are naïve (PCR negative and seronegative) to the relevant HPV types at Day 1. Vaccine impact in boys and men who were positive for vaccine HPV infection, as well as vaccine impact among boys and men regardless of baseline vaccine HPV PCR status and serostatus are also presented. The majority of anogenital disease related to a vaccine HPV type 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.

There was no clear evidence of protection from disease caused by HPV types for which boys and men were PCR positive regardless of serostatus at baseline.

Table 16: Effectiveness of GARDASIL in Prevention of HPV Types 6-, 11-, 16-, or 18-Related Anogenital Disease in Boys and Men 16 Through 26 Years of Age, Regardless of Current or Prior Exposure to Vaccine HPV Types
Endpoint Analysis GARDASIL AAHS Control % Reduction(95% CI)
N Cases N Cases
CI = Confidence Interval
AAHS Control = Amorphous Aluminum Hydroxyphosphate Sulfate
*
Includes all individuals who received at least 1 vaccination and who were HPV-naïve (i.e., seronegative and PCR negative) at Day 1 to the vaccine HPV type being analyzed. Case counting started at Day 1.
Includes all individuals who received at least 1 vaccination and who were HPV positive or had unknown HPV status at Day 1, to at least one vaccine HPV type. Case counting started at Day 1.
There is no expected efficacy since GARDASIL has not been demonstrated to provide protection against disease from vaccine HPV types to which a person has previously been exposed through sexual activity.
§
Includes all individuals who received at least 1 vaccination. Case counting started at Day 1.
External Genital Lesions Prophylactic Efficacy * 1775 13 1770 54 76.3 (56.0, 88.1)
HPV 6, HPV 11, HPV 16, and/or HPV 18 Positive at Day 1 460 14 453 26
Boys and Men Regardless of Current or Prior Exposure to Vaccine or Non-Vaccine HPV Types § 1943 27 1937 80 66.7 (48.0, 79.3)
Condyloma Prophylactic Efficacy * 1775 10 1770 49 80.0 (59.9, 90.9)
HPV 6, HPV 11, HPV 16, and/or HPV 18 Positive at Day 1 460 14 453 25
Boys and Men Regardless of Current or Prior Exposure to Vaccine or Non-Vaccine HPV Types § 1943 24 1937 74 68.1 (48.8, 80.7)
PIN 1/2/3 Prophylactic Efficacy * 1775 4 1770 5 20.7 (-268.4, 84.3)
HPV 6, HPV 11, HPV 16, and/or HPV 18 Positive at Day 1 460 2 453 1
Boys and Men Regardless of Current or Prior Exposure to Vaccine or Non-Vaccine HPV Types § 1943 6 1937 6 0.3 (-272.8, 73.4)
AIN 1/2/3 Prophylactic Efficacy * 259 9 261 39 76.9 (51.4, 90.1)
HPV 6, HPV 11, HPV 16, and/or HPV 18 Positive at Day 1 103 29 116 38
Boys and Men Regardless of Current or Prior Exposure to Vaccine or Non-Vaccine HPV Types § 275 38 276 77 50.3 (25.7, 67.2)
AIN 2/3 Prophylactic Efficacy * 259 7 261 19 62.5 (6.9, 86.7)
HPV 6, HPV 11, HPV 16, and/or HPV 18 Positive at Day 1 103 11 116 20
Boys and Men Regardless of Current or Prior Exposure to Vaccine or Non-Vaccine HPV Types § 275 18 276 39 54.2 (18.0, 75.3)

Effectiveness of GARDASIL in Prevention of Any HPV Type Related Anogenital Disease in Boys and Men 16 Through 26 Years of Age, Regardless of Current or Prior Infection with Vaccine or Non-Vaccine HPV Types

The impact of GARDASIL against the overall burden of dysplastic or papillomatous anogenital disease regardless of HPV detection, results from a combination of prophylactic efficacy against vaccine HPV types, disease contribution from vaccine HPV types present at time of vaccination, the disease contribution from HPV types not contained in the vaccine, and disease in which HPV was not detected.

Additional efficacy analyses from Study 5 were conducted in 2 populations: (1) a generally HPV-naïve population that consisted of boys and men who are seronegative and PCR negative to HPV 6, 11, 16, and 18 and PCR negative to HPV 31, 33, 35, 39, 45, 51, 52, 56, 58 and 59 at Day 1, approximating a population of sexually-naïve boys and men and (2) the general study population of boys and men regardless of baseline HPV status, some of whom had HPV-related disease at Day 1.

Among generally HPV-naïve boys and men and among all boys and men in Study 5 (including boys and men with HPV infection at Day 1), GARDASIL reduced the overall incidence of anogenital disease (Table 17). These reductions were primarily due to reductions in lesions caused by HPV types 6, 11, 16, and 18 in boys and men naïve (seronegative and PCR negative) for the specific relevant vaccine HPV type. Infected boys and men may already have anogenital disease at Day 1 and some will develop anogenital disease during follow-up, either related to a vaccine or non-vaccine HPV type present at the time of vaccination or related to a non-vaccine HPV type not present at the time of vaccination.

Table 17: Effectiveness of GARDASIL in Prevention of Any HPV Type Related Anogenital Disease in Boys and Men 16 Through 26 Years of Age, Regardless of Current or Prior Infection with Vaccine or Non-Vaccine HPV Types
Endpoint Analysis GARDASIL AAHS Control % Reduction(95% CI)
N Cases N Cases
CI = Confidence Interval
AAHS Control = Amorphous Aluminum Hydroxyphosphate Sulfate
*
Includes all individuals who received at least 1 vaccination and who were seronegative and PCR negative at enrollment to HPV 6, 11, 16 and 18, and PCR negative at enrollment to HPV 31, 33, 35, 39, 45, 51, 52, 56, 58 and 59. Case counting started at Day 1.
Includes all individuals who received at least 1 vaccination. Case counting started at Day 1.
External Genital Lesions Prophylactic Efficacy * 1275 7 1270 37 81.5 (58.0, 93.0)
Boys and Men Regardless of Current or Prior Exposure to Vaccine or Non-Vaccine HPV Types 1943 38 1937 92 59.3 (40.0, 72.9)
Condyloma Prophylactic Efficacy * 1275 5 1270 33 85.2 (61.8, 95.5)
Boys and Men Regardless of Current or Prior Exposure to Vaccine or Non-Vaccine HPV Types 1943 33 1937 85 61.8 (42.3, 75.3)
PIN 1/2/3 Prophylactic Efficacy * 1275 2 1270 4 50.7 (-244.3, 95.5)
Boys and Men Regardless of Current or Prior Exposure to Vaccine or Non-Vaccine HPV Types 1943 8 1937 7 -13.9 (-269.0, 63.9)
AIN 1/2/3 Prophylactic Efficacy * 129 12 126 28 54.9 (8.4, 79.1)
Boys and Men Regardless of Current or Prior Exposure to Vaccine or Non-Vaccine HPV Types 275 74 276 103 25.7 (-1.1, 45.6)
AIN 2/3 Prophylactic Efficacy * 129 8 126 18 52.5 (-14.8, 82.1)
Boys and Men Regardless of Current or Prior Exposure to Vaccine or Non-Vaccine HPV Types 275 44 276 59 24.3 (-13.8, 50.0)

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