- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02576054
Safety and Tolerability Study of V501 in Japanese Boys (V501-200)
November 13, 2019 updated by: Merck Sharp & Dohme LLC
A Phase III, Open-Label, Clinical Trial to Study the Safety and Immunogenicity of the Quadrivalent HPV (Types 6, 11, 16, 18) L1 VLP Particle (VLP) Vaccine in 9- to 15-Year-Old Japanese Boys
This is a study of V501 [quadrivalent Human Papillomavirus (HPV) (Type 6, 11, 16 and 18) L1 virus-like particle (VLP) vaccine] in healthy Japanese boys.
This study will consist of two periods.
Period I of the study is to evaluate the immunogenicity and tolerability of V501 up to Month 7. Period II of the study is to evaluate the long-term immunogenicity and safety from Month 7 to Month 30.
Two analyses are planned.
The first analysis will be conducted when all subjects have completed their Month 7 visit or have been discontinued before that time.
The second analysis will be conducted at the end of study.
The primary hypothesis tested in this study is that seroconversion rates for the vaccine HPV types will be >90% at 4 weeks postdose 3.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
101
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Chiyoda-Ku, Tokyo, Japan, 102-8667
- MSD K.K.
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
9 years to 15 years (Child)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- Healthy Japanese male
- Have a legal representative who provides written informed consent for the trial on the participant's behalf
- Have a legal representative who is able to read, understand, and complete the vaccine report card
- Has not yet had coitarche and does not plan on becoming sexually active from Day 1 through Month 7 of the study
- Other inclusion criteria will be discussed with the investigator during screening
Exclusion Criteria:
- Currently enrolled in clinical studies of investigational agents
- History of known prior vaccination with an HPV vaccine or plans to receive one outside the study
- History of severe allergic reaction that required medical intervention
- Allergic to any vaccine component, including aluminum, yeast, or BENZONASE™
- Received immune globulin or blood-derived products in the past 6 months or plans to receive any before Month 7 of the study
- History of splenectomy, is currently immunocompromised, or has been diagnosed with immunodeficiency, Human Immunodeficiency Virus (HIV) infection, lymphoma, leukemia, systemic lupus erythematosus, rheumatoid arthritis, juvenile rheumatoid arthritis, inflammatory bowel disease, or other autoimmune condition
- Received immunosuppressive therapy in the past year, excluding inhaled, nasal, or topical corticosteroids
- Known thrombocytopenia or coagulation disorder that would contraindicate intramuscular injections
- Ongoing alcohol or drug abuse within the past 12 months
- History of genital warts or a positive test for HPV
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: V501
0.5 mL intramuscular injection on Day 1, Month 2, and Month 6
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Quadrivalent HPV [Type 6, 11, 16 and 18] L1 VLP vaccine), 0.5 mL intramuscular injection on Day 1, Month 2, and Month 6
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Participants With Seroconversion for HPV Types 6, 11, 16, and 18
Time Frame: Four weeks postdose 3 (Month 7)
|
Antibodies to HPV Types 6, 11, 16, and 18 were measured using a competitive luminex immunoassay 4 weeks after 3rd vaccination (Month 7).
Antibody titers were expressed as milli Merck units/mL (mMU/mL).
Seroconversion was defined as an anti-HPV 6 titer ≥20 mMU/mL, an anti-HPV 11 titer ≥16 mMU/mL, an anti-HPV 16 titer of ≥20 mMU/mL and an anti-HPV 18 titer of ≥24 mMU/mL.
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Four weeks postdose 3 (Month 7)
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Percentage of Participants With Elevated Oral Temperature (>=37.5° C)
Time Frame: Up to Day 5 after any vaccination
|
The parent/guardian of the participant was to record the participant's oral temperature in the evening after each study vaccination and daily for 4 days after each study vaccination.
Elevated temperature was defined as ≥99.5°F (≥37.5ºC).
The percentage of participants that had an elevated temperature was summarized.
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Up to Day 5 after any vaccination
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Percentage of Participants With an Injection-site Adverse Event
Time Frame: Up to Day 5 after any vaccination
|
An adverse event (AE) is defined as any untoward medical occurrence in a participant which does not necessarily have a causal relationship with study drug.
An AE can therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study drug or a protocol-specified procedure, whether or not considered related to the study drug or protocol-specified procedure.
Any worsening of a preexisting condition that is temporally associated with the study drug or protocol-specified procedure is also an AE.
The parent/guardian of the participant was to record the presence of any vaccination report card (VRC)-prompted injection-site AEs that occurred in the 5 days after any vaccination.
The percentage of participants with an injection-site AE prompted on the VRC (erythema, pain, and swelling) was summarized.
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Up to Day 5 after any vaccination
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Percentage of Participants With a Systemic Adverse Event
Time Frame: Up to Day 15 after any vaccination
|
An adverse event (AE) is defined as any untoward medical occurrence in a participant which does not necessarily have a causal relationship with study drug.
An AE can therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study drug or a protocol-specified procedure, whether or not considered related to the study drug or protocol-specified procedure.
Any worsening of a preexisting condition that is temporally associated with the study drug or protocol-specified procedure is also an AE.
The parent/guardian of the participant was to record the presence of any VRC-prompted systemic AEs that occurred in the 5 days after any vaccination.
The percentage of participants with a systemic AE was summarized.
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Up to Day 15 after any vaccination
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Percentage of Participants With a Serious Adverse Event
Time Frame: Up to Day 15 after any vaccination
|
An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the sponsor's product, whether or not considered related to the use of the product.
A serious adverse event (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, is a cancer, is an overdose, or is another important medical event.
The percentage of participants that experienced 1 or more SAEs was summarized.
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Up to Day 15 after any vaccination
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Percentage of Participants With a Vaccine-related Serious Adverse Event
Time Frame: Up to 30 months
|
An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the sponsor's product, whether or not considered related to the use of the product.
A serious adverse event (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, is a cancer, is an overdose, or is another important medical event.
The percentage of participants that experienced 1 or more SAEs that were considered at least possibly related to the study vaccine was summarized.
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Up to 30 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Geometric Mean Titers for Serum Anti-HPV Types 6, 11, 16, and 18 Participants Aged 9 to 15 Years Versus Participants Aged 16 to 26 Years
Time Frame: Four weeks postdose 3 (Month 7)
|
Antibodies to HPV Types 6, 11, 16, and 18 were measured using a competitive luminex immunoassay.
Antibody titers were expressed mMU/mL.
GMTs obtained for each anti-HPV from this study were compared to each of the ant-HPV GMTs obtained in study V501-122 (NCT NCT01862874) in which Japanese males 16 to 26 years received V501 in the same 3 dose regimen, to test a hypothesis that would demonstrate non-inferiority.
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Four weeks postdose 3 (Month 7)
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Geometric Mean Titers for Serum Anti-HPV Types 6, 11, 16, and 18: Persistence at 18 Months
Time Frame: 12 months postdose 3 (18 months)
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Antibodies to HPV Types 6, 11, 16, and 18 were measured using a competitive luminex immunoassay.
Antibody titers were expressed as mMU/mL.
|
12 months postdose 3 (18 months)
|
Geometric Mean Titers for Serum Anti-HPV Types 6, 11, 16, and 18: Persistence at 30 Months
Time Frame: 24 months postdose 3 (30 months)
|
Antibodies to HPV Types 6, 11, 16, and 18 were measured using a competitive luminex immunoassay.
Antibody titers were expressed as mMU/mL.
|
24 months postdose 3 (30 months)
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Percentage of Participants With Seroconversion for HPV Types 6, 11, 16, and 18: Persistence at 18 Months
Time Frame: 12 months postdose 3 (18 months)
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Serum antibodies to HPV types were measured with a competitive luminex immunoassay.
The serostatus cutoffs (mMU/mL) for HPV types were as follows: HPV Type 6: ≥20; HPV Type 11: ≥16; HPV Type 16: ≥20; HPV Type 18: ≥24
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12 months postdose 3 (18 months)
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Percentage of Participants With Seroconversion for HPV Types 6, 11, 16, and 18: Persistence at 30 Months
Time Frame: 24 months postdose 3 (30 months)
|
Serum antibodies to HPV types were measured with a competitive luminex immunoassay.
The serostatus cutoffs (mMU/mL) for HPV types were as follows: HPV Type 6: ≥20; HPV Type 11: ≥16; HPV Type 16: ≥20; HPV Type 18: ≥24.
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24 months postdose 3 (30 months)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 20, 2015
Primary Completion (Actual)
August 8, 2018
Study Completion (Actual)
August 8, 2018
Study Registration Dates
First Submitted
October 13, 2015
First Submitted That Met QC Criteria
October 13, 2015
First Posted (Estimate)
October 15, 2015
Study Record Updates
Last Update Posted (Actual)
November 25, 2019
Last Update Submitted That Met QC Criteria
November 13, 2019
Last Verified
November 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- V501-200
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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