Efficacy, Immunogenicity, and Safety Study of the 9vHPV Vaccine in Japanese Males (V503-064)

Study Overview
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Brief Summary
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The purposes of this phase 3, double-blind, placebo-controlled clinical study are to evaluate the efficacy of V503 (9-valent human papillomavirus [9vHPV] vaccine) in preventing HPV-related anogenital persistent infection, and to evaluate the safety/tolerability of V503, in Japanese males who are 16 to 26 years of age. It is hypothesized that administration of a 3-dose regimen of V503 reduces the combined incidence of HPV 6/11/16/18-related anogenital persistent infection, as well as the combined incidence of HPV 31/33/45/52/58-related anogenital persistent infection, compared with placebo. The study includes a Base Study to assess efficacy and safety of V503, and an Extension Study. Participants who received placebo in the Base Study will be eligible to receive V503 vaccine on Day 1, Month 2, and Month 6 of the Extension Study. Participants who received less than 3 doses of V503 in the Base Study will be offered the opportunity to complete the 3-dose regimen in the Extension Study.

Official Title
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A Phase 3, Randomized, Placebo-controlled Clinical Study to Evaluate the Efficacy, Immunogenicity and Safety of the 9vHPV Vaccine in Japanese Males, 16 to 26 Years of Age.

Conditions
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Warts, Genital, Neoplasms, Anal

Intervention / Treatment
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* Biological: V503
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Is a Japanese male 16 to 26 years of age Has no more than 5 lifetime sexual partners Exclusion Criteria: Has a history of known prior vaccination with an HPV vaccine or plans to receive one outside the study Has a history of external genital warts Has a history of severe allergic reaction that required medical intervention Has received immune globulin or blood-derived products in the past 3 months or plan to receive any before Month 7 of the study Has a history of splenectomy, is currently immunocompromised, or has been diagnosed with immunodeficiency, human immunodeficiency virus (HIV), lymphoma, leukemia, systemic lupus erythematosus, rheumatoid arthritis, juvenile rheumatoid arthritis, inflammatory bowel disease, or other autoimmune condition Has received immunosuppressive therapy in the past year, excluding inhaled, nasal, or topical corticosteroids and certain regimens of systemic corticosteroids Has a known thrombocytopenia or coagulation disorder that would contraindicate intramuscular injections Has ongoing alcohol or drug abuse within the past 12 months

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 26 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: V503<br>Participants receive an intramuscular (IM) injection of V503 at Day 1, Month 2, and Month 6. | Biological: V503<br>* 9-valent vaccine, HPV 6/11/16/18/31/33/45/52/58, L1 virus-like particle (VLP) 30/40/60/40/20/20/20/20/20 mcg per dose.<br>* Other names: GARDASIL™9;|
| Placebo Comparator: Placebo<br>Participants receive an IM injection of placebo at Day 1, Month 2, and Month 6. | Other: Placebo<br>* 0.9% sodium chloride (NaCL)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Combined incidence of HPV 6/11/16/18-related anogenital persistent infection | This endpoint is defined to have occurred in a participant 1) who is polymerase chain reaction (PCR) positive to HPV 6, 11, 16 or 18 in 2 consecutive anogenital or biopsy samples from at least 2 consecutive visits 6 months (+/- 1-month visit window) or longer apart, or 2) who has a pathology diagnosis of condyloma, penile/perineal/perianal intraepithelial neoplasia, or penile, perineal or perianal cancer and PCR detection of HPV 6, 11, 16, or 18 in an adjacent section and PCR positive for the same HPV type at a separate adjacent visit. The incidence of this endpoint is assessed in each treatment arm. | Up to 42 months | 
| Percentage of participants with solicited injection-site adverse events (AEs) | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. | Up to 5 days after injection | 
| Percentage of participants with ≥1 systemic AE | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. | Up to 15 days after injection | 
| Percentage of participants with ≥1 serious adverse events (SAEs) | An SAE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention, that results in death, is life-threatening, requires hospitalization or prolongs existing hospitalization, results in persistent/significant disability/incapacity, is a congenital birth defect, or is an other important medical event. | Up to 6 months postdose 3 (up to 12 months) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Combined incidence of HPV 31/33/45/52/58-related anogenital persistent infection | This endpoint is defined to have occurred in a participant 1) who is PCR positive to HPV 31, 33, 45, 52, or 58 in 2 consecutive anogenital or biopsy samples from at least 2 consecutive visits 6 months (+/- 1-month visit window) or longer apart, or 2) who has a pathology diagnosis of condyloma, penile/perineal/perianal intraepithelial neoplasia, or penile, perineal or perianal cancer and PCR detection of HPV 31, 33, 45, 52, or 58 in an adjacent section and PCR positive for the same HPV type at a separate adjacent visit. The incidence of this endpoint is assessed in each treatment arm. | Up to 42 months | 
| Geometric mean titers (GMTs) to HPV 6/11/16/18/31/33/45/52/58 | Serum antibody titers are measured with a competitive Luminex immunoassay (cLIA). | Month 7 |