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

Phase 3Active Not RecruitingNCT05314023

Merck Sharp & Dohme LLC1,590 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

1,590

Conditions

Genital Warts

Interventions

Eligibility

Sex: MALEMin age: 9 YearsMax age: 19 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (5)

Liucheng County Centers for Disease Control and Prevention ( Site 0005)

Liuzhou, Guangxi, China

Center for Disease Control and Prevention of Rong An ( Site 0006)

Liuzhou, Guangxi, China

Loudi Public Health Hospital (Loudi Occupational Disease Prevention And Treatment Hospital) ( Site 0

Louxing District, Hunan, China

Yuechi Disease Prevention and Control Center ( Site 0002)

Guang’an, Sichuan, China

Santai County Center for Disease Control and Prevention ( Site 0001)

Mianyang, Sichuan, China

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: Up to 72 months

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: Up to 72 months