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

Genital Warts Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05314023
• Other study ID #: V503-053
• Secondary ID: V503-053
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: May 7, 2022
• Est. completion date: February 19, 2029

Study information

• Verified date: January 2023
• Source: Merck Sharp & Dohme LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1590
• Est. completion date: February 19, 2029
• Est. primary completion date: February 19, 2029
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 9 Years to 19 Years

Eligibility

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.

Related Conditions & MeSH terms

• Condylomata Acuminata
• Genital Warts

Intervention

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.

Locations

Country	Name	City	State
China	Yuechi Disease Prevention and Control Center ( Site 0002)	Guang'an	Sichuan
China	Center for Disease Control and Prevention of Rong An ( Site 0006)	Liuzhou	Guangxi
China	Liucheng County Centers for Disease Control and Prevention ( Site 0005)	Liuzhou	Guangxi
China	Loudi Public Health Hospital (Loudi Occupational Disease Prevention And Treatment Hospital) ( Site 0	Louxing District	Hunan
China	Santai County Center for Disease Control and Prevention ( Site 0001)	Mianyang	Sichuan

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme LLC

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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