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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT02114385
First received: April 8, 2014
Last updated: March 7, 2017
Last verified: March 2017
  Purpose

Primary objective

To demonstrate that administration of the 9vHPV vaccine 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 Intervention Phase
Papilloma Viral Infection Biological: V503 Biological: GARDASIL Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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

Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Geometric mean titres to HPV 6, 11, 16 and 18 [ Time Frame: 4 weeks post dose 3 ]

Secondary Outcome Measures:
  • Seroconversion percentages to HPV 6, 11, 16, 18, 31, 33, 45, 52 and 58 [ Time Frame: 4 weeks post dose 3 ]
  • Geometric mean titres to HPV 31, 33, 45, 52 and 58 [ Time Frame: 4 weeks post dose 3 ]
  • Injection site adverse reactions and elevated temperatures [ Time Frame: Day 1 to Day 5 post-vaccination ]
  • Systemic adverse events [ Time Frame: Day 1 to Day 15 post-vaccination ]
  • Serious adverse events [ Time Frame: From signature of informed consent to 1 month following the last vaccination ]

Enrollment: 500
Study Start Date: March 2014
Study Completion Date: September 2015
Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: V503 (9vHPV)
0.5 mL intramuscular injection at Day 1, Month 2 and Month 6
Biological: V503
Active Comparator: GARDASIL
0.5 mL intramuscular injection at Day 1, Month 2 and Month 6
Biological: GARDASIL

Detailed Description:

Secondary objectives

  • To evaluate the tolerability of the 9vHPVvaccine 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 9vHPVvaccine or GARDASIL
  Eligibility

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02114385

Locations
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.
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT02114385     History of Changes
Other Study ID Numbers: V503-020
2013-003399-10 ( EudraCT Number )
GDS07C ( Other Identifier: MCMVaccBV (SPMSD) Protocol Number )
Study First Received: April 8, 2014
Last Updated: March 7, 2017

Keywords provided by Merck Sharp & Dohme Corp.:
Prevention

Additional relevant MeSH terms:
Papilloma
Virus Diseases
Papillomavirus Infections
Neoplasms, Squamous Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
DNA Virus Infections
Tumor Virus Infections

ClinicalTrials.gov processed this record on June 23, 2017