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

February 20, 2018 updated by: Merck Sharp & Dohme LLC

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

500

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Ghent, Belgium
        • Sanofi Pasteur MSD Investigational Site 1002
      • Leuven, Belgium
        • Sanofi Pasteur MSD Investigational Site 1003
      • Wilrijk, Belgium
        • Sanofi Pasteur MSD Investigational Site 1001
  • Germany
      • Mainz, Germany
        • Sanofi Pasteur MSD Investigational Site 3001
  • Netherlands
      • Amsterdam, Netherlands
        • Sanofi Pasteur MSD Investigational Site 4001
      • Amsterdam, Netherlands
        • Sanofi Pasteur MSD Investigational Site 4003
      • Nijmegen, Netherlands
        • Sanofi Pasteur MSD Investigational Site 4002

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 26 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • qHPV vaccine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
4 weeks postdose 3 (Month 7)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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
The percentage of participants with one or more systemic adverse events was assessed.
Up to 15 days after any vaccination
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.
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)
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.
4 weeks postdose 3 (Month 7)
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.
Up to 15 days after any vaccination
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.
Up to Month 7
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.
Up to 5 days after any vaccination
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.
Up to 15 days after any vaccination

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck Sharp & Dohme LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 24, 2014

Primary Completion (Actual)

April 22, 2015

Study Completion (Actual)

April 22, 2015

Study Registration Dates

First Submitted

April 8, 2014

First Submitted That Met QC Criteria

April 11, 2014

First Posted (Estimate)

April 15, 2014

Study Record Updates

Last Update Posted (Actual)

November 1, 2018

Last Update Submitted That Met QC Criteria

February 20, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • V503-020
  • 2013-003399-10 (EudraCT Number)
  • GDS07C (Other Identifier: MCMVaccBV (SPMSD) Protocol Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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