Clinical trial NCT05314023: Immunogenicity and Safety of V503 in Chinese Males 9 Through 19 Years Old (V503-053)
Official title: 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Genital Warts
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2022-04-06
Enrollment: 1590
Sex: MALE
Minimum age (years): 9
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Competitive Luminex immunoassay (cLIA) GMTs to 9 vaccine types of 9vHPV vaccine at one month post last dose
timeFrame: Up to Month 13
measure: cLIA GMTs to 9 vaccine types of 9vHPV vaccine up to 60 months post last dose
timeFrame: Up to 72 months
measure: cLIA seropositivity percentages to 9 vaccine types of 9vHPV vaccine
timeFrame: Up to 72 months
Secondary outcomes:
measure: cLIA seroconversion percentages to 9 vaccine types of 9vHPV vaccine
timeFrame: Up to Month 13
measure: Immunoglobulin G Luminex immunoassay (IgG LIA) GMTs to 9 vaccine types of 9vHPV vaccine at one month post last dose
timeFrame: Up to Month 13
measure: IgG LIA seroconversion percentages to 9 vaccine types of 9vHPV vaccine
timeFrame: Up to Month 13
measure: Percentage of participants experiencing solicited injection-site adverse events (AEs),
timeFrame: Day 1 through Day 8 following any study vaccination
measure: Percentage of participants experiencing solicited systemic AEs
timeFrame: Day 1 through Day 8 following any study vaccination
measure: Percentage of participants experiencing serious AEs (SAEs)
timeFrame: Up to 72 months
measure: IgG LIA GMTs to 9 vaccine types of 9vHPV vaccine up to 60 months post last dose
timeFrame: Up to 72 months
measure: IgG LIA seropositivity percentages to 9 vaccine types of 9vHPV vaccine
timeFrame: Up to 72 months
Other outcomes:
Locations:
city: Liuzhou
country: China
facility: Liucheng County Centers for Disease Control and Prevention ( Site 0005)
state: Guangxi
city: Liuzhou
country: China
facility: Center for Disease Control and Prevention of Rong An ( Site 0006)
state: Guangxi
city: Louxing District
country: China
facility: Loudi Public Health Hospital (Loudi Occupational Disease Prevention And Treatment Hospital) ( Site 0
state: Hunan
city: Guang'an
country: China
facility: Yuechi Disease Prevention and Control Center ( Site 0002)
state: Sichuan
city: Mianyang
country: China
facility: Santai County Center for Disease Control and Prevention ( Site 0001)
state: Sichuan
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References: