Anogenital Human Papilloma Virus InfectionPhase 3NCT02576054

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

A Phase 3 study testing V501 in people with Anogenital Human Papilloma Virus Infection and Condyloma Acuminata, run by Merck Sharp & Dohme LLC at 1 site in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 9 to 15 years, men onlyHealthy volunteers can take part
Conditions the study is for: Anogenital Human Papilloma Virus Infection, Condyloma Acuminata
What is being tested?: V501
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 101 participants
Where: 1 siteJapan
Study dates: 20 Nov 2015to 8 Aug 2018
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 9 to 15 years
Men only
Healthy volunteers accepted
Child

Who may be able to join

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

Who cannot join

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

Show all 10Show fewer

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

Trial locations and contacts

1 site in 1 country.

Japan1 site

MSD K.K.
Chiyoda-Ku, Tokyo, 102-8667

Other trials in Japan

About this study

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

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.

Conditions: Anogenital Human Papilloma Virus Infection, Condyloma Acuminata
Being tested: V501

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

V501Biological
Also called Gardasil™
Quadrivalent HPV [Type 6, 11, 16 and 18] L1 VLP vaccine), 0.5 mL intramuscular injection on Day 1, Month 2, and Month 6

Study groups in NCT02576054
Study group	Role	What they receive
V501	Experimental	0.5 mL intramuscular injection on Day 1, Month 2, and Month 6 Receives: Biological: V501

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Four weeks postdose 3 (Month 7)
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.
Measured: Up to Day 5 after any vaccination
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.
Measured: Up to Day 5 after any vaccination
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.
Measured: Up to Day 15 after any vaccination
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.
Measured: Up to Day 15 after any vaccination
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.
Measured: Up to 30 months

Secondary outcomes (5)

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.
Measured: Four weeks postdose 3 (Month 7)
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.
Measured: 12 months postdose 3 (18 months)
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.
Measured: 24 months postdose 3 (30 months)
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
Measured: 12 months postdose 3 (18 months)
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.
Measured: 24 months postdose 3 (30 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

20 Nov 20158 Aug 2018

First posted15 Oct 2015 (estimated)
Study start20 Nov 2015
Primary completion8 Aug 2018
Study completion8 Aug 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Anogenital Human Papilloma Virus InfectionStudies of the same condition, open and under way.
More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Prevention
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 101 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02576054
Sponsor's protocol ID: V501-200
Status last verified: Nov 2019
First submitted: 13 Oct 2015
Last updated: 25 Nov 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: Yes: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

Publications

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.
PubMed 31155600

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 25 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT02576054
Acronym / sponsor ID: V501-200
Conditions: Anogenital Human Papilloma Virus Infection, Condyloma Acuminata
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 101 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: 20 Nov 2015 (actual)
Primary completion: 8 Aug 2018 (actual)
Study completion: 8 Aug 2018 (actual)
First posted: 15 Oct 2015 (estimated)
Results: Posted 6 Sep 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Prevention
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
V501	Experimental	Biological: V5010.5 mL intramuscular injection on Day 1, Month 2, and Month 6

Who may qualify

Ages: 9 to 15 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (5 listed)

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

Key exclusion criteria (10 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
V501Also: Gardasil™Quadrivalent HPV [Type 6, 11, 16 and 18] L1 VLP vaccine), 0.5 mL intramuscular injection on Day 1, Month 2, and Month 6	Biological	V501

Primary outcome

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.
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.
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.
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.
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.
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.

5 secondary outcomes

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)
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)
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)
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)
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)

Results and safety

Results posted to the registry on 6 Sep 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
V501	101	100

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

Time frame: Four weeks postdose 3 (Month 7). Mean (95% Confidence Interval). Unit: Percentage of Participants

Measure	V501 n = 99
Anti HPV 6	94.9 (88.5 to 98.3)
Anti HPV 11	99.0 (94.4 to 100.0)
Anti HPV 16	99.0 (94.5 to 100.0)
Anti HPV 18	99.0 (94.4 to 100.0)

Population analysed: All participants that received all 3 vaccinations within acceptable day ranges, were seronegative to the relevant HPV type at Day 1, did not have protocol violations that could interfere with evaluation of the immune response, and provided Month 7 serology result within 21 to 49 days post dose 3.

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

Time frame: Up to Day 5 after any vaccination. Number. Unit: Percentage of Participants

Measure	V501 n = 100
≥ 37.5 °C (99.5 °F) and < 38.0 °C (100.4 °F)	3.0
≥ 38.0 °C (100.4 °F) and < 38.5 °C (101.3 °F)	1.0
≥ 38.5 °C (101.3 °F)	2.0

Population analysed: All participants who received at least 1 study vaccination and had follow-up safety data.

Primary outcome: Percentage of Participants With an Injection-site Adverse Event

Time frame: Up to Day 5 after any vaccination. Number. Unit: Percentage of Participants

Measure	V501 n = 100
Value	64.0

Population analysed: All participants who received at least 1 study vaccination and had follow-up safety data.

Primary outcome: Percentage of Participants With a Systemic Adverse Event

Time frame: Up to Day 15 after any vaccination. Number. Unit: Percentage of Participants

Measure	V501 n = 100
Value	21.0

Population analysed: All participants who received at least 1 study vaccination and had follow-up safety data.

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to 30 months. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
V501	0 of 100 (0%)	67 of 100 (67%)	0 of 100

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 31155600Murata 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.
Individual participant dataSharing planned: Yes. http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Medical Director study director

Merck Sharp & Dohme LLC

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing V501 in people with Anogenital Human Papilloma Virus Infection and Condyloma Acuminata, run by Merck Sharp & Dohme LLC at 1 site in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Sep 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants With Seroconversion for HPV Types 6, 11, 16, and 18 (time frame: Four weeks postdose 3 (Month 7)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02576054, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2019.