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

NCT02114385 | Completed Phase 3 Results

• 3 other identifiers: V503-0202013-003399-10GDS07C
• Study Type: interventional
• Target: 500
• Locations: 3 countries
• Sites: 7

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

Conditions

Papilloma Viral Infection

Keywords

Prevention

Outcome Measures

Primary Outcomes (1)

• 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.

  4 weeks postdose 3 (Month 7)

Secondary Outcomes (8)

• GMTs to HPV Types 31/33/45/52/58

  4 weeks postdose 3 (Month 7)

• Percentage of Participants Who Are Seropositive for HPV Types 6/11/16/18/31/33/45/52/58

  4 weeks postdose 3 (Month 7)

• Percentage of Participants With One or More Adverse Events

  Up to 15 days after any vaccination

• Percentage of Participants With Study Discontinuation Due to an Adverse Event

  Up to Month 7

• Percentage of Participants With One or More Injection-site Adverse Reactions

  Up to 5 days after any vaccination

Study Arms (2)

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

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

Biological: GARDASIL

Interventions

V503 BIOLOGICAL

9-valent HPV \[Types 6, 11, 16, 18, 31, 33, 45, 52, and 58\] L1 virus-like particle vaccine, 0.5-mL intramuscular injection

Also known as: 9vHPV vaccine

V503

GARDASIL BIOLOGICAL

Quadrivalent HPV \[Types 6, 11, 16, and 18\] L1 virus-like particle vaccine, 0.5-mL intramuscular injection

Also known as: qHPV vaccine

GARDASIL

Eligibility Criteria

• Age: 16 Years - 26 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Study Sites (7)

Sanofi Pasteur MSD Investigational Site 1002

Ghent, Belgium

Location

Sanofi Pasteur MSD Investigational Site 1003

Leuven, Belgium

Location

Sanofi Pasteur MSD Investigational Site 1001

Wilrijk, Belgium

Location

Sanofi Pasteur MSD Investigational Site 3001

Mainz, Germany

Location

Sanofi Pasteur MSD Investigational Site 4001

Amsterdam, Netherlands

Location

Sanofi Pasteur MSD Investigational Site 4003

Amsterdam, Netherlands

Location

Sanofi Pasteur MSD Investigational Site 4002

Nijmegen, Netherlands

Location

Related Publications (2)

• 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.

  PMID: 27354258 RESULT

• 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.

  PMID: 29211620 DERIVED

MeSH Terms

Conditions

Papillomavirus Infections

Interventions

Human Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18

Condition Hierarchy (Ancestors)

Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; Infections; DNA Virus Infections; Virus Diseases; Tumor Virus Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Vaccines, Combined; Vaccines; Biological Products; Complex Mixtures; Papillomavirus Vaccines; Viral Vaccines

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp.

ClinicalTrialsDisclosure@merck.com

1-800-672-6372

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2014
• First Posted: April 15, 2014
• Study Start: March 24, 2014
• Primary Completion: April 22, 2015
• Study Completion: April 22, 2015
• Last Updated: November 1, 2018
• Results First Posted: November 1, 2018

Record last verified: 2018-02

Locations

BE (3); NL (3); DE (1)