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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02114385
Recruitment Status : Completed
First Posted : April 15, 2014
Results First Posted : November 1, 2018
Last Update Posted : November 1, 2018
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Brief 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


Condition or disease Intervention/treatment Phase
Papilloma Viral Infection Biological: V503 Biological: GARDASIL Phase 3

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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
Study Start Date : March 24, 2014
Actual Primary Completion Date : April 22, 2015
Actual Study Completion Date : April 22, 2015

Arm Intervention/treatment
Experimental: V503
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
Biological: V503
9-valent HPV [Types 6, 11, 16, 18, 31, 33, 45, 52, and 58] L1 virus-like particle vaccine, 0.5-mL intramuscular injection
Other Name: 9vHPV vaccine

Active Comparator: GARDASIL
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
Biological: GARDASIL
Quadrivalent HPV [Types 6, 11, 16, and 18] L1 virus-like particle vaccine, 0.5-mL intramuscular injection
Other Name: qHPV vaccine




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. GMTs to HPV Types 31/33/45/52/58 [ Time Frame: 4 weeks postdose 3 (Month 7) ]
    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.

  2. 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) ]
    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.

  3. Percentage of Participants With One or More Adverse Events [ Time Frame: Up to 15 days after any vaccination ]
    The percentage of participants with one or more adverse events was assessed.

  4. Percentage of Participants With Study Discontinuation Due to an Adverse Event [ Time Frame: Up to Month 7 ]
    The percentage of participants discontinued from the study due to an adverse event was assessed.

  5. Percentage of Participants With One or More Injection-site Adverse Reactions [ Time Frame: Up to 5 days after any vaccination ]
    The percentage of participants with one or more injection-site adverse reactions (solicited or unsolicited) was assessed.

  6. Percentage of Participants With Maximum Temperature ≥37.8 °C [ Time Frame: Up to 5 days after any vaccination ]
    The percentage of participants with a maximum temperature ≥37.8 °C was assessed.

  7. Percentage of Participants With One or More Systemic Adverse Events [ Time Frame: Up to 15 days after any vaccination ]
    The percentage of participants with one or more systemic adverse events was assessed.

  8. Percentage of Participants With One or More Serious Adverse Events [ Time Frame: Up to 15 days after any vaccination ]
    The percentage of participants with one or more serious adverse events was assessed.



Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 26 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02114385


Locations
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Belgium
Sanofi Pasteur MSD Investigational Site 1002
Ghent, Belgium
Sanofi Pasteur MSD Investigational Site 1003
Leuven, Belgium
Sanofi Pasteur MSD Investigational Site 1001
Wilrijk, Belgium
Germany
Sanofi Pasteur MSD Investigational Site 3001
Mainz, Germany
Netherlands
Sanofi Pasteur MSD Investigational Site 4001
Amsterdam, Netherlands
Sanofi Pasteur MSD Investigational Site 4003
Amsterdam, Netherlands
Sanofi Pasteur MSD Investigational Site 4002
Nijmegen, Netherlands
Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
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Study Director: Medical Director Merck Sharp & Dohme Corp.

Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT02114385    
Other Study ID Numbers: V503-020
2013-003399-10 ( EudraCT Number )
GDS07C ( Other Identifier: MCMVaccBV (SPMSD) Protocol Number )
First Posted: April 15, 2014    Key Record Dates
Results First Posted: November 1, 2018
Last Update Posted: November 1, 2018
Last Verified: February 2018
Keywords provided by Merck Sharp & Dohme Corp.:
Prevention
Additional relevant MeSH terms:
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Papillomavirus Infections
Papilloma
Virus Diseases
Neoplasms, Squamous Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
DNA Virus Infections
Tumor Virus Infections
Vaccines
Immunologic Factors
Physiological Effects of Drugs