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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
First received
Last updated
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
Health authority
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 (GARDASILâ„¢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.

Study Design


Related Conditions & MeSH terms


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
See also
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Completed NCT03158220 - Immunogenicity and Tolerability of Broad Spectrum Human Papillomavirus (HPV) Vaccine in Adult and Young Adult Women (V503-004) Phase 3
Completed NCT01651949 - Multivalent HPV (Human Papillomavirus) Vaccine Study in 16- to 26-Year Old Men and Women (V503-003) Phase 3
Completed NCT00551187 - A Study to Evaluate Tolerability and Immunogenicity of V504 Administered Concomitantly With GARDASIL (V504-001)(COMPLETED) Phase 2
Completed NCT00520598 - Broad Spectrum HPV (Human Papillomavirus) Vaccine in 16 to 26 Year Old Women (V505-001) Phase 2
Terminated NCT01468636 - A RTC to Examine the Effectiveness of 400 mg of Oral Zinc Gluconate as Adjunctive Therapy for Ano-genital Warts Phase 4
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Completed NCT00189293 - Study of Imiquimod Cream Prior to Ablative Therapy in External Ano-Genital Warts Phase 4
Active, not recruiting NCT00092534 - Cervical Intraepithelial Neoplasm (CIN) in Women (Gardasil) (V501-015) Phase 3
Completed NCT02462187 - Topical NVN1000 for the Treatment of External Genital and Perianal Warts Phase 2
Completed NCT00501137 - A Controlled Trial to Assess the Immunogenicity of a Proposed Paediatric Dosing Schedule of Human Papillomavirus Vaccine Phase 3
Active, not recruiting NCT02750202 - Effectiveness Study of Human Papilloma Virus (HPV) Vaccines to Prevent Recurrence of Genital Warts Phase 3
Active, not recruiting NCT02653118 - Long-term Follow-up of Broad Spectrum Human Papillomavirus (HPV) Vaccine Study in Women (V503-021)