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

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

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 Overview

• Status: Active, not recruiting
• Conditions: Genital Warts
• Intervention / Treatment: Biological: 9vHPV vaccine

• Study Type: Interventional
• Enrollment (Anticipated): 1590
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Guangxi
    • Liuzhou, Guangxi, China, 545200
      • Liucheng County Centers for Disease Control and Prevention ( Site 0005)
    • Liuzhou, Guangxi, China, 545400
      • Center for Disease Control and Prevention of Rong An ( Site 0006)
  • Hunan
    • Louxing District, Hunan, China, 417000
      • Loudi Public Health Hospital (Loudi Occupational Disease Prevention And Treatment Hospital) ( Site 0
  • Sichuan
    • Guang'an, Sichuan, China, 638399
      • Yuechi Disease Prevention and Control Center ( Site 0002)
    • Mianyang, Sichuan, China, 621100
      • Santai County Center for Disease Control and Prevention ( Site 0001)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 9 years to 19 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 9 to 19 Years Old: Day 1, Months 2 and 6; 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; 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.; Other Names: V503; GARDASIL™9
Experimental: 9 to 14 Years Old: Day 1, and Month 6; 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; 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.; Other Names: V503; GARDASIL™9
Experimental: 9 to 14 Years Old: Day 1 and Month 12; 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; 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.; Other Names: V503; GARDASIL™9

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Merck Sharp & Dohme LLC

Study record dates

Study Major Dates

• Study Start (Actual): May 7, 2022
• Primary Completion (Anticipated): February 19, 2029
• Study Completion (Anticipated): February 19, 2029

Study Registration Dates

• First Submitted: March 29, 2022
• First Submitted That Met QC Criteria: March 29, 2022
• First Posted (Actual): April 6, 2022

Study Record Updates

• Last Update Posted (Actual): January 19, 2023
• Last Update Submitted That Met QC Criteria: January 18, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Virus Diseases; Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; DNA Virus Infections; Skin Diseases, Infectious; Warts; Papillomavirus Infections; Skin Diseases, Viral; Tumor Virus Infections; Condylomata Acuminata
• Other Study ID Numbers: V503-053 (Other Identifier: Merck)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes