Immunogenicity and Safety of V503 in Chinese Males 9 Through 19 Years Old (V503-053)

Study Overview
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Brief Summary
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This study is designed to demonstrate non-inferior immunogenicity of 3 doses of the 9-Valent Human Papillomavirus (9vHPV) vaccine (GARDASIL™9, V503) in Chinese males 9 through 19 years of age, and 2 doses of the 9vHPV vaccine in Chinese males 9 through 14 years of age, compared to the 3 dose regimen in Chinese males 20 through 26 years of age (from Merck Protocol V503-052). The primary hypothesis is that each of the 3-dose regimen in Chinese males aged 9 through 19 years and 2-dose regimens in Chinese males aged 9 through 14 years induces non-inferior competitive Luminex immunoassay (cLIA) geometric mean titers (GMTs) at one month post last dose compared to the 3-dose regimen in Chinese adult males aged 20 through 26 years. A noninferiority margin of 0.67 in the GMT ratio (9 through 19 years of age or 9 through 14 years of age vs 20 through 26 years of age) is used for each HPV type.

Official Title
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A Phase 3 Open-Label Immunogenicity and Safety Study of 2-Dose Regimens of V503, a 9-Valent Human Papillomavirus (HPV) Vaccine in Chinese Males 9 Through 14 Years Old and 3-Dose Regimen of V503 in Chinese Males 9 Through 19 Years Old

Conditions
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Genital Warts

Intervention / Treatment
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* Biological: 9vHPV vaccine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Is a healthy Chinese male. Has not had sexual debut at the time of enrollment, and does not plan on becoming sexually active during the vaccination period (Day 1 through one month post last dose). Exclusion Criteria: Has a history of known prior vaccination with an HPV vaccine. Has a history of HPV-related external genital lesions, HPV-related intra-anal lesions, or HPV-related head and neck cancer. Has a history of severe allergic reaction that required medical intervention. Has received immune globulin or blood-derived products in the past 6 months or plans to receive any before one month post last dose. 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 IM injections.

Ages Eligible for Study
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Minimum Age: 9 Years
Maximum Age: 19 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: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 9 to 19 Years Old: Day 1, Months 2 and 6<br>Chinese males 9 to 19 years old will receive a 0.5 mL intramuscular (IM) injection of 9-valent HPV (9vHPV) vaccine on Day 1, Month 2 and Month 6 | Biological: 9vHPV vaccine<br>* A 9-valent HPV vaccine (Types 6, 11, 16, 18, 31, 33, 45, 52, and 58) will be administered as a 0.5 mL IM injection.<br>* Other names: GARDASIL™9;|
| Experimental: 9 to 14 Years Old: Day 1, and Month 6<br>Chinese males 9 to 14 years old will receive a 0.5 mL IM injection of 9vHPV vaccine on Day 1 and Month 6 | Biological: 9vHPV vaccine<br>* A 9-valent HPV vaccine (Types 6, 11, 16, 18, 31, 33, 45, 52, and 58) will be administered as a 0.5 mL IM injection.<br>* Other names: GARDASIL™9;|
| Experimental: 9 to 14 Years Old: Day 1 and Month 12<br>Chinese males 9 to 14 years old will receive a 0.5 mL IM injection of 9vHPV vaccine on Day 1 and Month 12 | Biological: 9vHPV vaccine<br>* A 9-valent HPV vaccine (Types 6, 11, 16, 18, 31, 33, 45, 52, and 58) will be administered as a 0.5 mL IM injection.<br>* Other names: GARDASIL™9;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Competitive Luminex immunoassay (cLIA) GMTs to 9 vaccine types of 9vHPV vaccine at one month post last dose | cLIA GMT to each of 9 vaccine types of 9vHPV vaccine at one month post last dose. The GMT for each HPV type will be reported in mMU/mL. | Up to Month 13 | 
| cLIA GMTs to 9 vaccine types of 9vHPV vaccine up to 60 months post last dose | cLIA GMT to each of 9 vaccine types of 9vHPV vaccine at up to 60 months post last dose. The GMT for each HPV type will be reported in mMU/mL. | Up to 72 months | 
| cLIA seropositivity percentages to 9 vaccine types of 9vHPV vaccine | cLIA seropositivity to each of 9 vaccine types of 9vHPV vaccine. The percentage of participants who are seropositive for each HPV type will be summarized. | Up to 72 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cLIA seroconversion percentages to 9 vaccine types of 9vHPV vaccine | cLIA seroconversion to each of 9 vaccine types of 9vHPV vaccine. The percentage of participants who are seropositive for each HPV type will be summarized. | Up to Month 13 | 
| Immunoglobulin G Luminex immunoassay (IgG LIA) GMTs to 9 vaccine types of 9vHPV vaccine at one month post last dose | IgG LIA GMT to each of 9 vaccine types of 9vHPV vaccine at one month post last dose. The GMT for each HPV type will be reported in mMU/mL. | Up to Month 13 | 
| IgG LIA seroconversion percentages to 9 vaccine types of 9vHPV vaccine | IgG LIA seroconversion to each of 9 vaccine types of 9vHPV vaccine. The percentage of participants who are seropositive for each HPV type will be summarized. | Up to Month 13 | 
| Percentage of participants experiencing solicited injection-site adverse events (AEs), | An AE is any untoward medical occurrence in a participant which does not necessarily have a causal relationship with study vaccine. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of study vaccine or a protocol-specified procedure, whether or not considered related to the study vaccine or protocol-specified procedure. Solicited injection-site AEs such as erythema, swelling, pain, and induration at the injection site will be recorded. | Day 1 through Day 8 following any study vaccination | 
| Percentage of participants experiencing solicited systemic AEs | An AE is any untoward medical occurrence in a participant which does not necessarily have a causal relationship with study vaccine. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of study vaccine or a protocol-specified procedure, whether or not considered related to the study vaccine or protocol-specified procedure. Systemic AEs are those not categorized as injection-site AEs. | Day 1 through Day 8 following any study vaccination | 
| Percentage of participants experiencing serious AEs (SAEs) | A SAE is an AE that results in death, is life threatening, results in a persistent or significant disability or incapacity, results in or prolongs an existing hospitalization, is a congenital anomaly or birth defect, or is another important medical event. | Up to 72 months | 
| IgG LIA GMTs to 9 vaccine types of 9vHPV vaccine up to 60 months post last dose | IgG LIA GMT to each of 9 vaccine types of 9vHPV vaccine up to 60 months post last dose. The GMT for each HPV type will be reported in mMU/mL. | Up to 72 months | 
| IgG LIA seropositivity percentages to 9 vaccine types of 9vHPV vaccine | IgG LIA seropositivity to each of 9 vaccine types of 9vHPV vaccine. The percentage of participants who are seropositive for each HPV type will be summarized. | Up to 72 months |