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

Primary Purpose

Genital Warts

Status
Active
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
9vHPV vaccine
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Genital Warts

Eligibility Criteria

9 Years - 19 Years (Child, Adult)MaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Liucheng County Centers for Disease Control and Prevention ( Site 0005)
  • Center for Disease Control and Prevention of Rong An ( Site 0006)
  • Loudi Public Health Hospital (Loudi Occupational Disease Prevention And Treatment Hospital) ( Site 0
  • Yuechi Disease Prevention and Control Center ( Site 0002)
  • Santai County Center for Disease Control and Prevention ( Site 0001)

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

9 to 19 Years Old: Day 1, Months 2 and 6

9 to 14 Years Old: Day 1, and Month 6

9 to 14 Years Old: Day 1 and Month 12

Arm Description

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

Chinese males 9 to 14 years old will receive a 0.5 mL IM injection of 9vHPV vaccine on 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 12

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.

Full Information

First Posted
March 29, 2022
Last Updated
January 18, 2023
Sponsor
Merck Sharp & Dohme LLC
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1. Study Identification

Unique Protocol Identification Number
NCT05314023
Brief Title
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

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 7, 2022 (Actual)
Primary Completion Date
February 19, 2029 (Anticipated)
Study Completion Date
February 19, 2029 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck Sharp & Dohme LLC

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Genital Warts

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
1590 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
9 to 19 Years Old: Day 1, Months 2 and 6
Arm Type
Experimental
Arm Description
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
Arm Title
9 to 14 Years Old: Day 1, and Month 6
Arm Type
Experimental
Arm Description
Chinese males 9 to 14 years old will receive a 0.5 mL IM injection of 9vHPV vaccine on Day 1 and Month 6
Arm Title
9 to 14 Years Old: Day 1 and Month 12
Arm Type
Experimental
Arm Description
Chinese males 9 to 14 years old will receive a 0.5 mL IM injection of 9vHPV vaccine on Day 1 and Month 12
Intervention Type
Biological
Intervention Name(s)
9vHPV vaccine
Other Intervention Name(s)
V503, GARDASIL™9
Intervention Description
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.
Primary Outcome Measure Information:
Title
Competitive Luminex immunoassay (cLIA) GMTs to 9 vaccine types of 9vHPV vaccine at one month post last dose
Description
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
Title
cLIA GMTs to 9 vaccine types of 9vHPV vaccine up to 60 months post last dose
Description
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
Title
cLIA seropositivity percentages to 9 vaccine types of 9vHPV vaccine
Description
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 Outcome Measure Information:
Title
cLIA seroconversion percentages to 9 vaccine types of 9vHPV vaccine
Description
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
Title
Immunoglobulin G Luminex immunoassay (IgG LIA) GMTs to 9 vaccine types of 9vHPV vaccine at one month post last dose
Description
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
Title
IgG LIA seroconversion percentages to 9 vaccine types of 9vHPV vaccine
Description
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
Title
Percentage of participants experiencing solicited injection-site adverse events (AEs),
Description
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
Title
Percentage of participants experiencing solicited systemic AEs
Description
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
Title
Percentage of participants experiencing serious AEs (SAEs)
Description
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
Title
IgG LIA GMTs to 9 vaccine types of 9vHPV vaccine up to 60 months post last dose
Description
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
Title
IgG LIA seropositivity percentages to 9 vaccine types of 9vHPV vaccine
Description
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

10. Eligibility

Sex
Male
Gender Based
Yes
Gender Eligibility Description
Chinese males only
Minimum Age & Unit of Time
9 Years
Maximum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Merck Sharp & Dohme LLC
Official's Role
Study Director
Facility Information:
Facility Name
Liucheng County Centers for Disease Control and Prevention ( Site 0005)
City
Liuzhou
State/Province
Guangxi
ZIP/Postal Code
545200
Country
China
Facility Name
Center for Disease Control and Prevention of Rong An ( Site 0006)
City
Liuzhou
State/Province
Guangxi
ZIP/Postal Code
545400
Country
China
Facility Name
Loudi Public Health Hospital (Loudi Occupational Disease Prevention And Treatment Hospital) ( Site 0
City
Louxing District
State/Province
Hunan
ZIP/Postal Code
417000
Country
China
Facility Name
Yuechi Disease Prevention and Control Center ( Site 0002)
City
Guang'an
State/Province
Sichuan
ZIP/Postal Code
638399
Country
China
Facility Name
Santai County Center for Disease Control and Prevention ( Site 0001)
City
Mianyang
State/Province
Sichuan
ZIP/Postal Code
621100
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
IPD Sharing URL
http://engagezone.msd.com/ds_documentation.php

Learn more about this trial

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

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