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Multivalent HPV (Human Papillomavirus) Vaccine Study in 16- to 26-Year Old Men and Women (V503-003)

Primary Purpose

Genital Warts, Anal Cancer, Anal Intraepithelial Neoplasia

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
9vHPV Vaccine
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Genital Warts

Eligibility Criteria

16 Years - 26 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Good physical health
  • Has never had Papanicolaou testing (Pap, cervical or anal) or has only had normal Pap test results
  • Other inclusion criteria will be discussed with the investigator

Exclusion Criteria:

  • History of severe allergic reaction that required medical intervention
  • Currently enrolled in a clinical trial
  • If participant is female, pregnant
  • Currently immunocompromised or having received immunosuppressive therapy in the last year
  • Positive test for HPV
  • History of HPV-related external genital lesions or HPV-related anal lesions or anal cancer
  • If participant is female, history of abnormal cervical biopsy results
  • Other exclusion criteria will be discussed with the investigator

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Active Comparator

    Experimental

    Experimental

    Arm Label

    Females

    Heterosexual Males

    Men who have Sex with Men

    Arm Description

    Healthy females 16 to 26 years of age received 9vHPV vaccine 0.5 mL intramuscular injection on Day 1, Month 2, and Month 6

    Healthy heterosexual males 16 to 26 years of age received 9vHPV 0.5 mL intramuscular injection on Day 1, Month 2, and Month 6

    Healthy MSM 16 to 26 years of age received 9vHPV 0.5 mL intramuscular injection on Day 1, Month 2, and Month 6

    Outcomes

    Primary Outcome Measures

    Geometric Mean Titers (GMTs) to the HPV Types Contained in the 9vHPV Vaccine
    Serum antibodies to HPV types 6/11/16/18/31/33/45/52/58 were measured with a Competitive Luminex Immunoassay. Titers are reported in milli Merck Units/mL
    Percentage of Participants With One or More Injection-site Adverse Experiences Prompted on the Vaccination Report Card
    An adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an AE. Injection-site AEs prompted on the Vaccination Report Card (VRC) were erythema, pain, and swelling. Participants were instructed to use the Vaccination Report Card to record AEs daily after each study vaccination.
    Percentage of Participants With Elevated Oral Body Temperature (>=37.8° C, >=100° F)
    Participants were instructed by the investigator to use the Vaccination Report Card to document evening oral temperature daily after each study vaccination
    Percentage of Participants With an Adverse Event
    An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an AE.
    Percentage of Participants Who Had Study Vaccine Discontinued Due to an Adverse Event
    An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an AE.

    Secondary Outcome Measures

    Percentage of Participants With Seroconversion to the HPV Types Contained in the 9vHPV Vaccine
    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 Types 33, 45, 52, and 58: ≥8.

    Full Information

    First Posted
    July 25, 2012
    Last Updated
    October 30, 2018
    Sponsor
    Merck Sharp & Dohme LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01651949
    Brief Title
    Multivalent HPV (Human Papillomavirus) Vaccine Study in 16- to 26-Year Old Men and Women (V503-003)
    Official Title
    A Phase III Clinical Trial to Study the Tolerability and Immunogenicity of 9vHPV (V503), a Multivalent Human Papillomavirus (HPV) L1 Virus-Like Particle (VLP) Vaccine, in 16- to 26-Year-Old Men and 16- to 26-Year-Old Women
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    October 29, 2012 (Actual)
    Primary Completion Date
    August 4, 2014 (Actual)
    Study Completion Date
    August 4, 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Merck Sharp & Dohme LLC

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    This study is designed to evaluate the immunogenicity and tolerability of 9vHPV (9-valent HPV vaccine, V503) in 16- to 26-year old men and women. The overall goal is to bridge 9vHPV efficacy findings in young women to young men based on the demonstration of similar immunogenicity and safety profiles. The primary hypothesis is that 9vHPV induces antibody responses at 4 weeks postdose 3 in heterosexual males that are non-inferior to antibody responses in young women.
    Detailed Description
    Study participants will be administered a 3-dose regimen of 9vHPV. They will be assessed for immunogenicity 1 month following completion of vaccination. All participants will be followed for safety for a total of 12 months.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Genital Warts, Anal Cancer, Anal Intraepithelial Neoplasia

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    2520 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Females
    Arm Type
    Active Comparator
    Arm Description
    Healthy females 16 to 26 years of age received 9vHPV vaccine 0.5 mL intramuscular injection on Day 1, Month 2, and Month 6
    Arm Title
    Heterosexual Males
    Arm Type
    Experimental
    Arm Description
    Healthy heterosexual males 16 to 26 years of age received 9vHPV 0.5 mL intramuscular injection on Day 1, Month 2, and Month 6
    Arm Title
    Men who have Sex with Men
    Arm Type
    Experimental
    Arm Description
    Healthy MSM 16 to 26 years of age received 9vHPV 0.5 mL intramuscular injection on Day 1, Month 2, and Month 6
    Intervention Type
    Biological
    Intervention Name(s)
    9vHPV Vaccine
    Intervention Description
    9vHPV, V503 (9-valent HPV [Types 6, 11, 16, 18, 31, 33, 45, 52, and 58] L1 virus-like particle vaccine), 0.5 mL injection in 3-dose regimen
    Primary Outcome Measure Information:
    Title
    Geometric Mean Titers (GMTs) to the HPV Types Contained in the 9vHPV Vaccine
    Description
    Serum antibodies to HPV types 6/11/16/18/31/33/45/52/58 were measured with a Competitive Luminex Immunoassay. Titers are reported in milli Merck Units/mL
    Time Frame
    Four weeks post vaccination 3 (Month 7)
    Title
    Percentage of Participants With One or More Injection-site Adverse Experiences Prompted on the Vaccination Report Card
    Description
    An adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an AE. Injection-site AEs prompted on the Vaccination Report Card (VRC) were erythema, pain, and swelling. Participants were instructed to use the Vaccination Report Card to record AEs daily after each study vaccination.
    Time Frame
    Up to 5 days after any vaccination
    Title
    Percentage of Participants With Elevated Oral Body Temperature (>=37.8° C, >=100° F)
    Description
    Participants were instructed by the investigator to use the Vaccination Report Card to document evening oral temperature daily after each study vaccination
    Time Frame
    Up to 5 days after any vaccination
    Title
    Percentage of Participants With an Adverse Event
    Description
    An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an AE.
    Time Frame
    Up to Month 12
    Title
    Percentage of Participants Who Had Study Vaccine Discontinued Due to an Adverse Event
    Description
    An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an AE.
    Time Frame
    Up to Month 12
    Secondary Outcome Measure Information:
    Title
    Percentage of Participants With Seroconversion to the HPV Types Contained in the 9vHPV Vaccine
    Description
    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 Types 33, 45, 52, and 58: ≥8.
    Time Frame
    Four weeks post vaccination 3 (Month 7)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    16 Years
    Maximum Age & Unit of Time
    26 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Good physical health Has never had Papanicolaou testing (Pap, cervical or anal) or has only had normal Pap test results Other inclusion criteria will be discussed with the investigator Exclusion Criteria: History of severe allergic reaction that required medical intervention Currently enrolled in a clinical trial If participant is female, pregnant Currently immunocompromised or having received immunosuppressive therapy in the last year Positive test for HPV History of HPV-related external genital lesions or HPV-related anal lesions or anal cancer If participant is female, history of abnormal cervical biopsy results Other exclusion criteria will be discussed with the investigator
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Medical Director
    Organizational Affiliation
    Merck Sharp & Dohme LLC
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf
    IPD Sharing URL
    http://engagezone.msd.com/ds_documentation.php
    Citations:
    PubMed Identifier
    26144901
    Citation
    Castellsague X, Giuliano AR, Goldstone S, Guevara A, Mogensen O, Palefsky JM, Group T, Shields C, Liu K, Maansson R, Luxembourg A, Kaplan SS. Immunogenicity and safety of the 9-valent HPV vaccine in men. Vaccine. 2015 Nov 27;33(48):6892-901. doi: 10.1016/j.vaccine.2015.06.088. Epub 2015 Jul 2.
    Results Reference
    background
    PubMed Identifier
    27422279
    Citation
    Moreira ED Jr, Block SL, Ferris D, Giuliano AR, Iversen OE, Joura EA, Kosalaraksa P, Schilling A, Van Damme P, Bornstein J, Bosch FX, Pils S, Cuzick J, Garland SM, Huh W, Kjaer SK, Qi H, Hyatt D, Martin J, Moeller E, Ritter M, Baudin M, Luxembourg A. Safety Profile of the 9-Valent HPV Vaccine: A Combined Analysis of 7 Phase III Clinical Trials. Pediatrics. 2016 Aug;138(2):e20154387. doi: 10.1542/peds.2015-4387. Epub 2016 Jul 15.
    Results Reference
    derived
    Available IPD and Supporting Information:
    Available IPD/Information Type
    CSR Synopsis
    Available IPD/Information URL
    http://www.merck.com/clinical-trials/study.html?id=V503-003&kw=V503-003&tab=access

    Learn more about this trial

    Multivalent HPV (Human Papillomavirus) Vaccine Study in 16- to 26-Year Old Men and Women (V503-003)

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