Papilloma Viral InfectionPhase 3NCT02114385

A Study to Compare Immune Response of V503 to Gardasil in 16- to 26-year-old Men (V503-020)

A Phase 3 study testing V503 and GARDASIL in people with Papilloma Viral Infection, run by Merck Sharp & Dohme LLC at 7 sites in 3 countries.

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

Primary objective To demonstrate that administration of V503 induces non-inferior Geometric Mean Titres (GMTs) for serum anti-HPV 6, 11, 16, and 18, compared to GARDASIL in 16- to 26-year-old men Read more about this study

Who is it for?: Ages 16 to 26 yearsHealthy volunteers can take part
Conditions the study is for: Papilloma Viral Infection
What is being tested?: V503 and GARDASIL
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 500 participants
Where: 7 sitesin 3 countries
Study dates: 24 Mar 2014to 22 Apr 2015
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 16 to 26 years
All sexes
Healthy volunteers accepted
Child, Adult

Who may be able to join

Subject is a man, between the ages of 16 years and 0 days and 26 years and 364 days on the day of enrolment.
Subject is a man who has had no more than 5 lifetime female sexual partners.
Subject is judged to be in good physical health on the basis of medical history, physical examination, and laboratory results.
Subject, or subject's parent or guardian, fully understand study procedures, alternative treatments available, the risks involved with the study, and voluntarily agree to participate by giving written informed consent.

Who cannot join

Subject who has had sex with a male partner.
Subject has a history of HPV-related external genital lesions or HPV-related anal lesions
Subject has a known allergy to any vaccine component, including aluminium, yeast, or BENZONASE
Subject has a history of severe allergic reaction that required medical intervention.
Subject has thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injections.
Subject is concurrently enrolled in clinical studies of investigational medicinal products.

Show all 18Show fewer

Subject has donated blood within 1 week prior to the Day 1 vaccination, or intends to donate during Day 1 through Month 7 of the study.
Subject is currently immunocompromised or has been diagnosed as having a congenital or acquired immunodeficiency, HIV infection, lymphoma, leukemia, systemic lupus erythematosus, rheumatoid arthritis, juvenile rheumatoid arthritis, inflammatory bowel disease, or other autoimmune condition.
Subject has had a splenectomy.
Subject is receiving or has received in the year prior to enrolment the following immunosuppressive therapies: radiation therapy, cyclophosphamide, azathioprine, methotrexate, any chemotherapy, cyclosporin, leflunomide, TNF-α antagonists, monoclonal antibody therapies, intravenous gamma globulin, antilymphocyte sera, or other therapy known to interfere with the immune response.
Subject has received any immune globulin product or blood-derived product within the 6 months prior to the Day 1 vaccination, or plans to receive any such product during Day 1 through Month 7 of the study.
Subject has received non-replicating (inactivated) vaccines within 14 days prior to the Day 1 vaccination or has received replicating (live) vaccines within 21 days prior to the Day 1 vaccination.
Subject has received a marketed HPV vaccine, or has participated in an HPV vaccine clinical trial and has received either active agent or placebo.
Subject has had a fever within the 24-hour period prior to the Day 1 vaccination.
Subject has a history or current evidence of any condition, therapy, laboratory abnormality or other circumstance that might confound the results of the study, or interfere with the subject's participation for the full duration of the study, such that it is not in the best interest of the subject to participate.
Subject is unlikely to adhere to the study procedures, keep appointments, or is planning to relocate during the study.
Subject is, at the time of signing informed consent, a user of recreational or illicit drugs or has had a recent history (within the last year) of drug abuse or dependence. Alcohol abusers are defined as those who drink despite recurrent social, interpersonal, and/or legal problems as a result of alcohol use.
Subject, or subject's parent or guardian, is or has an immediate family member (spouse or children) who is investigational site or sponsor staff directly involved with this trial.

Trial locations and contacts

7 sites in 3 countries.

Country

City, postcode or hospital

7 sites in 3 countries

Belgium3 sites

Sanofi Pasteur MSD Investigational Site 1002
Ghent
Sanofi Pasteur MSD Investigational Site 1003
Leuven
Sanofi Pasteur MSD Investigational Site 1001
Wilrijk

Other trials in Belgium

Netherlands3 sites

Sanofi Pasteur MSD Investigational Site 4001
Amsterdam
Sanofi Pasteur MSD Investigational Site 4003
Amsterdam
Sanofi Pasteur MSD Investigational Site 4002
Nijmegen

Other trials in Netherlands

Germany1 site

Sanofi Pasteur MSD Investigational Site 3001
Mainz

Other trials in Germany

About this study

Official title: A Randomized, Double-Blinded, Controlled With GARDASIL (Human Papillomavirus Vaccine [HPV] [Types 6, 11, 16, 18] (Recombinant, Adsorbed)), Phase 3 Clinical Trial to Study the Immunogenicity and Tolerability of V503 (9-Valent Human Papillomavirus L1 Virus-Like Particle [VLP] Vaccine) in 16- to 26-year-old Men

Primary objective

To demonstrate that administration of V503 induces non-inferior Geometric Mean Titres (GMTs) for serum anti-HPV 6, 11, 16, and 18, compared to GARDASIL in 16- to 26-year-old men

Read the detailed description

Secondary objectives

To evaluate the tolerability of V503 in 16- to 26-year-old men.
To summarise humoral immune responses, including anti-HPV 6, 11, 16, 18, 31, 33, 45, 52, 58 GMTs and seroconversion rates at 4 weeks post-dose 3, in 16- to 26-year-old men who received V503 or GARDASIL

Conditions: Papilloma Viral Infection
Being tested: V503, GARDASIL
Keywords: Prevention
Medical subject headings: Papillomavirus Infections

What participants receive

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

V503Biological
Also called 9vHPV vaccine
9-valent HPV [Types 6, 11, 16, 18, 31, 33, 45, 52, and 58] L1 virus-like particle vaccine, 0.5-mL intramuscular injection
GARDASILBiological
Also called qHPV vaccine
Quadrivalent HPV [Types 6, 11, 16, and 18] L1 virus-like particle vaccine, 0.5-mL intramuscular injection

Study groups in NCT02114385
Study group	Role	What they receive
V503	Experimental	9-valent HPV [Types 6, 11, 16, 18, 31, 33, 45, 52, and 58] L1 virus-like particle vaccine, 0.5-mL intramuscular injection in 3 dose regimen at Day 1, Month 2, and Month 6 Receives: Biological: V503
GARDASIL	Active comparator	Quadrivalent HPV [Types 6, 11, 16, and 18] L1 virus-like particle vaccine, 0.5-mL intramuscular injection in 3 dose regimen at Day 1, Month 2, and Month 6 Receives: Biological: GARDASIL

What is being measured

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

Geometric Mean Titers (GMTs) to HPV Types 6/11/16/18
Serum antibodies to HPV types 6, 11, 16, and 18 were measured with a Competitive Luminex Immunoassay. Titers are reported in milli Merck Units/mL.
Measured: 4 weeks postdose 3 (Month 7)

Secondary outcomes (8)

GMTs to HPV Types 31/33/45/52/58
Serum antibodies to HPV types 31, 33, 45, 52, and 58 were measured with a Competitive Luminex Immunoassay. Titers are reported in milli Merck Units/mL.
Measured: 4 weeks postdose 3 (Month 7)
Percentage of Participants Who Are Seropositive for HPV Types 6/11/16/18/31/33/45/52/58
Serum antibodies to HPV types were measured with a Competitive Luminex Immunoassay. The serostatus cutoffs (milli Merck U/mL) for HPV types were as follows: HPV Type 6: ≥30; HPV Type 11: ≥16; HPV Type 16: ≥20; HPV Type 18: ≥24; HPV Type 31: ≥10; HPV Type 33: ≥8; HPV Type 45: ≥8; HPV Type 52: ≥8; HPV Type 58: ≥8.
Measured: 4 weeks postdose 3 (Month 7)
Percentage of Participants With One or More Adverse Events
The percentage of participants with one or more adverse events was assessed.
Measured: Up to 15 days after any vaccination
Percentage of Participants With Study Discontinuation Due to an Adverse Event
The percentage of participants discontinued from the study due to an adverse event was assessed.
Measured: Up to Month 7
Percentage of Participants With One or More Injection-site Adverse Reactions
The percentage of participants with one or more injection-site adverse reactions (solicited or unsolicited) was assessed.
Measured: Up to 5 days after any vaccination
Percentage of Participants With Maximum Temperature ≥37.8 °C
The percentage of participants with a maximum temperature ≥37.8 °C was assessed.
Measured: Up to 5 days after any vaccination
Percentage of Participants With One or More Systemic Adverse Events
The percentage of participants with one or more systemic adverse events was assessed.
Measured: Up to 15 days after any vaccination
Percentage of Participants With One or More Serious Adverse Events
The percentage of participants with one or more serious adverse events was assessed.
Measured: Up to 15 days after any vaccination

Timeline

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

24 Mar 201422 Apr 2015

First posted15 Apr 2014 (estimated)
Study start24 Mar 2014
Primary completion22 Apr 2015
Study completion22 Apr 2015

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 (2)Papers the sponsor has linked to this study.
Other trials for Papilloma Viral 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: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 500 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02114385
Sponsor's protocol ID: V503-020
Other IDs: 2013-003399-10, GDS07C
Status last verified: Feb 2018
First submitted: 8 Apr 2014
Last updated: 1 Nov 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Van Damme P, Meijer CJLM, Kieninger D, Schuyleman A, Thomas S, Luxembourg A, Baudin M. A phase III clinical study to compare the immunogenicity and safety of the 9-valent and quadrivalent HPV vaccines in men. Vaccine. 2016 Jul 29;34(35):4205-4212. doi: 10.1016/j.vaccine.2016.06.056. Epub 2016 Jun 25.
PubMed 27354258
Moreira ED, Giuliano AR, de Hoon J, Iversen OE, Joura EA, Restrepo J, Van Damme P, Vandermeulen C, Ellison MC, Krick A, Shields C, Heiles B, Luxembourg A. Safety profile of the 9-valent human papillomavirus vaccine: assessment in prior quadrivalent HPV vaccine recipients and in men 16 to 26 years of age. Hum Vaccin Immunother. 2018 Feb 1;14(2):396-403. doi: 10.1080/21645515.2017.1403700. Epub 2017 Dec 14.
PubMed 29211620

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?

See locations

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Human Papillomavirus Infection
Not yet recruitingPhase 2
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Respiratory Recurrent Papillomatosis (RRP), Human Papillomavirus (HPV)
RecruitingPhase 2
A Study of the Preliminary Efficacy of DARE-HPV to Treat High-risk Persistent Human Papillomavirus (hrHPV)
Human Papilloma Virus (HPV), High-risk Human Papillomavirus Infection
RecruitingObservational study
Lived Experiences of Women Diagnosed With HPV Infection
Human Papillomavirus Infection
RecruitingObservational study
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All Papilloma Viral Infection trials

Study at a glance

From the registry record, last updated by the sponsor on 1 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-Blinded, Controlled With GARDASIL (Human Papillomavirus Vaccine [HPV] [Types 6, 11, 16, 18] (Recombinant, Adsorbed)), Phase 3 Clinical Trial to Study the Immunogenicity and Tolerability of V503 (9-Valent Human Papillomavirus L1 Virus-Like Particle [VLP] Vaccine) in 16- to 26-year-old Men
ClinicalTrials.gov ID: NCT02114385
Acronym / sponsor ID: V503-020
Conditions: Papilloma Viral Infection
Keywords: Prevention
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 500 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: 24 Mar 2014
Primary completion: 22 Apr 2015 (actual)
Study completion: 22 Apr 2015 (actual)
First posted: 15 Apr 2014 (estimated)
Results: Posted 1 Nov 2018

Clinical summary

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

Primary objective

To demonstrate that administration of V503 induces non-inferior Geometric Mean Titres (GMTs) for serum anti-HPV 6, 11, 16, and 18, compared to GARDASIL in 16- to 26-year-old men

Detailed description

Secondary objectives

To evaluate the tolerability of V503 in 16- to 26-year-old men.
To summarise humoral immune responses, including anti-HPV 6, 11, 16, 18, 31, 33, 45, 52, 58 GMTs and seroconversion rates at 4 weeks post-dose 3, in 16- to 26-year-old men who received V503 or GARDASIL

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
V503	Experimental	Biological: V5039-valent HPV [Types 6, 11, 16, 18, 31, 33, 45, 52, and 58] L1 virus-like particle vaccine, 0.5-mL intramuscular injection in 3 dose regimen at Day 1, Month 2, and Month 6
GARDASIL	Active comparator	Biological: GARDASILQuadrivalent HPV [Types 6, 11, 16, and 18] L1 virus-like particle vaccine, 0.5-mL intramuscular injection in 3 dose regimen at Day 1, Month 2, and Month 6

Who may qualify

Ages: 16 to 26 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult

Key inclusion criteria (4 listed)

Subject is a man, between the ages of 16 years and 0 days and 26 years and 364 days on the day of enrolment.
Subject is a man who has had no more than 5 lifetime female sexual partners.
Subject is judged to be in good physical health on the basis of medical history, physical examination, and laboratory results.
Subject, or subject's parent or guardian, fully understand study procedures, alternative treatments available, the risks involved with the study, and voluntarily agree to participate by giving written informed consent.

Key exclusion criteria (18 listed)

Subject who has had sex with a male partner.
Subject has a history of HPV-related external genital lesions or HPV-related anal lesions
Subject has a known allergy to any vaccine component, including aluminium, yeast, or BENZONASE
Subject has a history of severe allergic reaction that required medical intervention.
Subject has thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injections.

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
V503Also: 9vHPV vaccine9-valent HPV [Types 6, 11, 16, 18, 31, 33, 45, 52, and 58] L1 virus-like particle vaccine, 0.5-mL intramuscular injection	Biological	V503
GARDASILAlso: qHPV vaccineQuadrivalent HPV [Types 6, 11, 16, and 18] L1 virus-like particle vaccine, 0.5-mL intramuscular injection	Biological	GARDASIL

Primary outcome

Geometric Mean Titers (GMTs) to HPV Types 6/11/16/18
Time frame: 4 weeks postdose 3 (Month 7)
Serum antibodies to HPV types 6, 11, 16, and 18 were measured with a Competitive Luminex Immunoassay. Titers are reported in milli Merck Units/mL.

8 secondary outcomes

GMTs to HPV Types 31/33/45/52/58
Time frame: 4 weeks postdose 3 (Month 7)
Percentage of Participants Who Are Seropositive for HPV Types 6/11/16/18/31/33/45/52/58
Time frame: 4 weeks postdose 3 (Month 7)
Percentage of Participants With One or More Adverse Events
Time frame: Up to 15 days after any vaccination
Percentage of Participants With Study Discontinuation Due to an Adverse Event
Time frame: Up to Month 7
Percentage of Participants With One or More Injection-site Adverse Reactions
Time frame: Up to 5 days after any vaccination
Percentage of Participants With Maximum Temperature ≥37.8 °C
Time frame: Up to 5 days after any vaccination
Percentage of Participants With One or More Systemic Adverse Events
Time frame: Up to 15 days after any vaccination
Percentage of Participants With One or More Serious Adverse Events
Time frame: Up to 15 days after any vaccination

Results and safety

Results posted to the registry on 1 Nov 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
V503	249	246
GARDASIL	251	243

Primary outcome: Geometric Mean Titers (GMTs) to HPV Types 6/11/16/18

Time frame: 4 weeks postdose 3 (Month 7). Geometric mean (95% Confidence Interval). Unit: milli Merck U/mL

Measure	V503 n = 249	GARDASIL n = 251
HPV Type 6	758.3 (665.9 to 863.4)	618.4 (554.0 to 690.3)
HPV Type 11	681.7 (608.9 to 763.4)	769.1 (683.5 to 865.3)
HPV Type 16	3924.1 (3513.8 to 4382.3)	3787.9 (3378.4 to 4247.0)
HPV Type 18	884.3 (766.4 to 1020.4)	790.9 (683.0 to 915.7)

V503 vs GARDASIL: GMT Ratio: 1.23 (95% CI 1.04 to 1.45), p <0.001, ANOVA
V503 vs GARDASIL: GMT Ratio: 0.89 (95% CI 0.76 to 1.04), p <0.001, ANOVA
V503 vs GARDASIL: GMT Ratio: 1.04 (95% CI 0.89 to 1.21), p <0.001, ANOVA

Population analysed: All randomized participants. The number contributing to each data point is participants who received all 3 vaccinations within acceptable day ranges, had Month 7 serology for the HPV type within acceptable day ranges, were seronegative at Day 1, and had no protocol violations that interfered with evaluation of immune response.

8 secondary outcomes are reported in the full results.

Adverse events

Time frame: All adverse events: up to 15 days after each vaccination; serious adverse events: up to Month 7. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
V503	0 of 248 (0%)	196 of 248 (79%)	Not reported
GARDASIL	6 of 248 (2.4%)	189 of 248 (76.2%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 27354258Van Damme P, Meijer CJLM, Kieninger D, Schuyleman A, Thomas S, Luxembourg A, Baudin M. A phase III clinical study to compare the immunogenicity and safety of the 9-valent and quadrivalent HPV vaccines in men. Vaccine. 2016 Jul 29;34(35):4205-4212. doi: 10.1016/j.vaccine.2016.06.056. Epub 2016 Jun 25.
Derived from this study: PubMed 29211620Moreira ED, Giuliano AR, de Hoon J, Iversen OE, Joura EA, Restrepo J, Van Damme P, Vandermeulen C, Ellison MC, Krick A, Shields C, Heiles B, Luxembourg A. Safety profile of the 9-valent human papillomavirus vaccine: assessment in prior quadrivalent HPV vaccine recipients and in men 16 to 26 years of age. Hum Vaccin Immunother. 2018 Feb 1;14(2):396-403. doi: 10.1080/21645515.2017.1403700. Epub 2017 Dec 14.

Related trials for Papilloma Viral Infection

Not yet recruitingPhase 1/2
Clinical Trial to Assess the Safety, Tolerability, Reactogenicity, and Immunogenicity of a 10 Valent Human Papillomavirus Virus (10vHPV) Vaccine
Human Papillomavirus Infection
Not yet recruitingPhase 2
Combination Bevacizumab and PRGN-2012 in Adults With Recurrent Respiratory Papillomatosis (RRP)
Respiratory Recurrent Papillomatosis (RRP), Human Papillomavirus (HPV)
RecruitingPhase 2
A Study of the Preliminary Efficacy of DARE-HPV to Treat High-risk Persistent Human Papillomavirus (hrHPV)
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RecruitingObservational study
Lived Experiences of Women Diagnosed With HPV Infection
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RecruitingObservational study
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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

7 sites in 3 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing V503 and GARDASIL in people with Papilloma Viral Infection, run by Merck Sharp & Dohme LLC at 7 sites in 3 countries.

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 4 inclusion and 18 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 1 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in Belgium, Netherlands, Germany. 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 1 Nov 2018). 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?

Geometric Mean Titers (GMTs) to HPV Types 6/11/16/18 (time frame: 4 weeks postdose 3 (Month 7)). 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 NCT02114385, which also lists 2 linked publications.

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 1 Nov 2018.