Safety and Tolerability Study of V501 in Japanese Boys (V501-200)

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Primary Purpose

Status

Completed

Phase

Phase 3

Locations

Japan

Study Type

Interventional

Intervention

V501

About this trial

This is an interventional prevention trial for Anogenital Human Papilloma Virus Infection

Eligibility Criteria

9 Years - 15 Years (Child)MaleAccepts Healthy Volunteers

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

Sites / Locations

MSD K.K.

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

V501

Arm Description

0.5 mL intramuscular injection on Day 1, Month 2, and Month 6

Outcomes

Primary Outcome Measures

Percentage of Participants With Seroconversion for HPV Types 6, 11, 16, and 18

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.

Percentage of Participants With Elevated Oral Temperature (>=37.5° C)

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.

Percentage of Participants With an Injection-site Adverse Event

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.

Percentage of Participants With a Systemic Adverse Event

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.

Percentage of Participants With a Serious Adverse Event

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.

Percentage of Participants With a Vaccine-related Serious Adverse Event

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.

Secondary Outcome Measures

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

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.

Geometric Mean Titers for Serum Anti-HPV Types 6, 11, 16, and 18: Persistence at 18 Months

Antibodies to HPV Types 6, 11, 16, and 18 were measured using a competitive luminex immunoassay. Antibody titers were expressed as mMU/mL.

Geometric Mean Titers for Serum Anti-HPV Types 6, 11, 16, and 18: Persistence at 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.

Percentage of Participants With Seroconversion for HPV Types 6, 11, 16, and 18: Persistence at 18 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

Percentage of Participants With Seroconversion for HPV Types 6, 11, 16, and 18: Persistence at 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.

Full Information

NCT ID

NCT02576054

First Posted

October 13, 2015

Last Updated

November 13, 2019

Sponsor

Merck Sharp & Dohme LLC

1. Study Identification

Unique Protocol Identification Number

NCT02576054

Brief Title

Safety and Tolerability Study of V501 in Japanese Boys (V501-200)

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2019

Overall Recruitment Status

Completed

Study Start Date

November 20, 2015 (Actual)

Primary Completion Date

August 8, 2018 (Actual)

Study Completion Date

August 8, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Merck Sharp & Dohme LLC

4. Oversight

Data Monitoring Committee

No

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

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

Anogenital Human Papilloma Virus Infection, Condyloma Acuminata

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

101 (Actual)

8. Arms, Groups, and Interventions

Arm Title

V501

Arm Type

Experimental

Arm Description

0.5 mL intramuscular injection on Day 1, Month 2, and Month 6

Intervention Type

Biological

Intervention Name(s)

V501

Other Intervention Name(s)

Gardasil™

Intervention Description

Quadrivalent HPV [Type 6, 11, 16 and 18] L1 VLP vaccine), 0.5 mL intramuscular injection on Day 1, Month 2, and Month 6

Primary Outcome Measure Information:

Title

Percentage of Participants With Seroconversion for HPV Types 6, 11, 16, and 18

Description

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.

Time Frame

Four weeks postdose 3 (Month 7)

Title

Percentage of Participants With Elevated Oral Temperature (>=37.5° C)

Description

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.

Time Frame

Up to Day 5 after any vaccination

Title

Percentage of Participants With an Injection-site Adverse Event

Description

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.

Time Frame

Up to Day 5 after any vaccination

Title

Percentage of Participants With a Systemic Adverse Event

Description

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.

Time Frame

Up to Day 15 after any vaccination

Title

Percentage of Participants With a Serious Adverse Event

Description

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.

Time Frame

Up to Day 15 after any vaccination

Title

Percentage of Participants With a Vaccine-related Serious Adverse Event

Description

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.

Time Frame

Up to 30 months

Secondary Outcome Measure Information:

Title

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

Description

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.

Time Frame

Four weeks postdose 3 (Month 7)

Title

Geometric Mean Titers for Serum Anti-HPV Types 6, 11, 16, and 18: Persistence at 18 Months

Description

Antibodies to HPV Types 6, 11, 16, and 18 were measured using a competitive luminex immunoassay. Antibody titers were expressed as mMU/mL.

Time Frame

12 months postdose 3 (18 months)

Title

Geometric Mean Titers for Serum Anti-HPV Types 6, 11, 16, and 18: Persistence at 30 Months

Description

Antibodies to HPV Types 6, 11, 16, and 18 were measured using a competitive luminex immunoassay. Antibody titers were expressed as mMU/mL.

Time Frame

24 months postdose 3 (30 months)

Title

Percentage of Participants With Seroconversion for HPV Types 6, 11, 16, and 18: Persistence at 18 Months

Description

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

Time Frame

12 months postdose 3 (18 months)

Title

Percentage of Participants With Seroconversion for HPV Types 6, 11, 16, and 18: Persistence at 30 Months

Description

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.

Time Frame

24 months postdose 3 (30 months)

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

9 Years

Maximum Age & Unit of Time

15 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

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

MSD K.K.

City

Chiyoda-Ku, Tokyo

ZIP/Postal Code

102-8667

Country

Japan

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

Citations:

PubMed Identifier

31155600

Citation

Murata S, Takeuchi Y, Yamanaka K, Hayakawa J, Yoshida M, Yokokawa R, Wakana A, Sawata M, Tanaka Y. Safety and Immunogenicity of the Quadrivalent HPV Vaccine in Japanese Boys: a Phase 3, Open-Label Study. Jpn J Infect Dis. 2019 Sep 19;72(5):299-305. doi: 10.7883/yoken.JJID.2018.448. Epub 2019 May 31.

Results Reference

result

Anogenital Human Papilloma Virus Infection, Condyloma Acuminata

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial