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Efficacy and Tolerability Study of V501 in Japanese Males (V501-122)

Primary Purpose

Anogenital Human Papilloma Virus Infection, Condyloma Acuminata

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
V501
Placebo
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Anogenital Human Papilloma Virus Infection

Eligibility Criteria

16 Years - 26 Years (Child, Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Japanese
  • No clinical evidence of gross genital lesion suggesting sexually-transmitted disease and no clinically present external genital warts
  • Other inclusion criteria will be discussed with the investigator during screening

Exclusion Criteria:

  • History of known prior vaccination with an HPV vaccine or plans to receive one outside the study
  • History of external genital warts
  • History of severe allergic reaction that required medical intervention
  • Received immune globulin or blood-derived products in the past 6 months or plan to receive any before Month 7 of the study
  • History of splenectomy, is currently immunocompromised, or has been diagnosed with immunodeficiency, Human Immunodeficiency Virus (HIV), lymphoma, leukemia, systemic lupus erythematosus, rheumatoid arthritis, juvenile rheumatoid arthritis, inflammatory bowel disease, or other autoimmune condition
  • Received immunosuppressive therapy in the past year, excluding inhaled, nasal, or topical corticosteroids and certain regimens of systemic corticosteroids
  • Known thrombocytopenia or coagulation disorder that would contraindicate intramuscular injections
  • Ongoing alcohol or drug abuse within the past 12 months

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    V501

    Placebo

    Arm Description

    Participants received V501 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Follow-up was up to Month 36.

    Participants received placebo 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Follow-up was up to Month 36.

    Outcomes

    Primary Outcome Measures

    Combined Incidence of HPV Type 6, 11, 16, or 18-related Persistent Infection
    Persistent infection was defined as 1) polymerase chain reaction (PCR) positive to HPV Type 6, 11, 16, or 18 in 2 consecutive anogenital or biopsy samples collected ≥4 months apart, or 2) Pathology Panel consensus diagnosis of condyloma acuminate, penile/perianal/perineal intraepithelial neoplasia (PIN), penile, perianal, or perineal cancer and PCR detection of HPV Type 6, 11, 16, or 18 in an adjacent section and PCR positive for the same HPV type at a separate adjacent visit. The combined incidence of HPV Type 6, 11, 16, or 18 persistent infection detected in samples from ≥2 consecutive visits ≥6 months apart was assessed.
    Percentage of Participants With Maximum Temperature ≥37.5°C Reported on the Vaccination Report Card
    Body temperature (oral or oral equivalent) was recorded on the Vaccination Report Card (VRC). The percentage of participants with a maximum temperature ≥37.5°C was summarized.
    Percentage of Participants With an Injection-site Adverse Event Prompted on the Vaccination Report Card
    An adverse event (AE) is defined as any untoward medical occurrence in a participant which does not necessarily have a causal relationship with study drug. An AE can therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study drug or a protocol-specified procedure, whether or not considered related to the study drug or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the study drug or protocol-specified procedure is also an AE. The percentage of participants with an injection-site AE prompted on the VRC (erythema, pain, and swelling) was summarized.
    Percentage of Participants With a Systemic Adverse Event
    An adverse event (AE) is defined as any untoward medical occurrence in a participant which does not necessarily have a causal relationship with study drug. An AE can therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study drug or a protocol-specified procedure, whether or not considered related to the study drug or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the study drug or protocol-specified procedure is also an AE. The percentage of participants with a systemic AE was summarized.
    Percentage of Participants With a Vaccine-related Systemic Adverse Event
    An adverse event (AE) is defined as any untoward medical occurrence in a participant which does not necessarily have a causal relationship with study drug. An AE can therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study drug or a protocol-specified procedure, whether or not considered related to the study drug or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the study drug or protocol-specified procedure is also an AE. Vaccine-related AEs are those that were deemed possibly, probably, or definitely related to vaccine administration by the investigator. The percentage of participants with a vaccine-related systemic AE was summarized.

    Secondary Outcome Measures

    Combined Incidence of HPV Type 6, 11, 16, or 18-related Persistent Infection or Disease
    Persistent infection was defined as 1) polymerase chain reaction (PCR) positive to HPV Type 6, 11, 16, or 18 in 2 consecutive anogenital or biopsy samples collected ≥4 months apart, or 2) Pathology Panel consensus diagnosis of condyloma acuminate, penile/perianal/perineal intraepithelial neoplasia (PIN), penile, perianal, or perineal cancer and PCR detection of HPV Type 6, 11, 16, or 18 in an adjacent section and PCR positive for the same HPV type at a separate adjacent visit. The incidence of persistent infection detected in samples from ≥2 consecutive visits ≥6 months apart was assessed. Disease was defined as HPV Type 6, 11, 16, or 18-related condyloma acuminate, PIN, penile, perianal, or perineal cancer. The combined incidence of HPV Type 6, 11, 16, or 18 persistent infection or disease was assessed.

    Full Information

    First Posted
    May 22, 2013
    Last Updated
    March 25, 2019
    Sponsor
    Merck Sharp & Dohme LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01862874
    Brief Title
    Efficacy and Tolerability Study of V501 in Japanese Males (V501-122)
    Official Title
    A Phase III Placebo-controlled Clinical Trial to Study the Tolerability, Immunogenicity and Efficacy of V501 in 16- to 26-year-old Japanese Men
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    June 27, 2013 (Actual)
    Primary Completion Date
    August 30, 2017 (Actual)
    Study Completion Date
    August 30, 2017 (Actual)

    3. Sponsor/Collaborators

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

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    A study to evaluate the efficacy and tolerability of V501 (quadrivalent Human Papilloma Virus [HPV] [Type 6, 11, 16 and 18] L1 Virus-Like Particle vaccine, GARDASIL™) in healthy, 16- to 26-year old Japanese males. The hypotheses tested are: 1) V501 reduces the combined incidence of HPV 6-, 11-, 16-, or 18-related persistent infection compared with placebo, and 2) V501 reduces the combined incidence of HPV 6-, 11-, 16-, or 18-related persistent infection, condyloma acuminata, penile/perianal/perineal intraepithelial neoplasia, or penile, perianal, or perineal cancer compared with placebo.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Anogenital Human Papilloma Virus Infection, Condyloma Acuminata

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    1124 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    V501
    Arm Type
    Experimental
    Arm Description
    Participants received V501 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Follow-up was up to Month 36.
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    Participants received placebo 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Follow-up was up to Month 36.
    Intervention Type
    Biological
    Intervention Name(s)
    V501
    Other Intervention Name(s)
    GARDASIL™, Quadrivalent HPV (Type 6, 11, 16 and 18) L1 Virus-Like Particle vaccine
    Intervention Description
    Formulated with aluminum hydroxyphosphate sulfate (AAHS) adjuvant
    Intervention Type
    Biological
    Intervention Name(s)
    Placebo
    Intervention Description
    Formulated with AAHS adjuvant
    Primary Outcome Measure Information:
    Title
    Combined Incidence of HPV Type 6, 11, 16, or 18-related Persistent Infection
    Description
    Persistent infection was defined as 1) polymerase chain reaction (PCR) positive to HPV Type 6, 11, 16, or 18 in 2 consecutive anogenital or biopsy samples collected ≥4 months apart, or 2) Pathology Panel consensus diagnosis of condyloma acuminate, penile/perianal/perineal intraepithelial neoplasia (PIN), penile, perianal, or perineal cancer and PCR detection of HPV Type 6, 11, 16, or 18 in an adjacent section and PCR positive for the same HPV type at a separate adjacent visit. The combined incidence of HPV Type 6, 11, 16, or 18 persistent infection detected in samples from ≥2 consecutive visits ≥6 months apart was assessed.
    Time Frame
    Up to Month 36
    Title
    Percentage of Participants With Maximum Temperature ≥37.5°C Reported on the Vaccination Report Card
    Description
    Body temperature (oral or oral equivalent) was recorded on the Vaccination Report Card (VRC). The percentage of participants with a maximum temperature ≥37.5°C was summarized.
    Time Frame
    Up to 5 days after any vaccination
    Title
    Percentage of Participants With an Injection-site Adverse Event Prompted on the Vaccination Report Card
    Description
    An adverse event (AE) is defined as any untoward medical occurrence in a participant which does not necessarily have a causal relationship with study drug. An AE can therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study drug or a protocol-specified procedure, whether or not considered related to the study drug or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the study drug or protocol-specified procedure is also an AE. The percentage of participants with an injection-site AE prompted on the VRC (erythema, pain, and swelling) was summarized.
    Time Frame
    Up to 5 days after any vaccination
    Title
    Percentage of Participants With a Systemic Adverse Event
    Description
    An adverse event (AE) is defined as any untoward medical occurrence in a participant which does not necessarily have a causal relationship with study drug. An AE can therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study drug or a protocol-specified procedure, whether or not considered related to the study drug or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the study drug or protocol-specified procedure is also an AE. The percentage of participants with a systemic AE was summarized.
    Time Frame
    Up to 15 days after any vaccination
    Title
    Percentage of Participants With a Vaccine-related Systemic Adverse Event
    Description
    An adverse event (AE) is defined as any untoward medical occurrence in a participant which does not necessarily have a causal relationship with study drug. An AE can therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study drug or a protocol-specified procedure, whether or not considered related to the study drug or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the study drug or protocol-specified procedure is also an AE. Vaccine-related AEs are those that were deemed possibly, probably, or definitely related to vaccine administration by the investigator. The percentage of participants with a vaccine-related systemic AE was summarized.
    Time Frame
    Up to 15 days after any vaccination
    Secondary Outcome Measure Information:
    Title
    Combined Incidence of HPV Type 6, 11, 16, or 18-related Persistent Infection or Disease
    Description
    Persistent infection was defined as 1) polymerase chain reaction (PCR) positive to HPV Type 6, 11, 16, or 18 in 2 consecutive anogenital or biopsy samples collected ≥4 months apart, or 2) Pathology Panel consensus diagnosis of condyloma acuminate, penile/perianal/perineal intraepithelial neoplasia (PIN), penile, perianal, or perineal cancer and PCR detection of HPV Type 6, 11, 16, or 18 in an adjacent section and PCR positive for the same HPV type at a separate adjacent visit. The incidence of persistent infection detected in samples from ≥2 consecutive visits ≥6 months apart was assessed. Disease was defined as HPV Type 6, 11, 16, or 18-related condyloma acuminate, PIN, penile, perianal, or perineal cancer. The combined incidence of HPV Type 6, 11, 16, or 18 persistent infection or disease was assessed.
    Time Frame
    Up to Month 36

    10. Eligibility

    Sex
    Male
    Minimum Age & Unit of Time
    16 Years
    Maximum Age & Unit of Time
    26 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Japanese No clinical evidence of gross genital lesion suggesting sexually-transmitted disease and no clinically present external genital warts Other inclusion criteria will be discussed with the investigator during screening Exclusion Criteria: History of known prior vaccination with an HPV vaccine or plans to receive one outside the study History of external genital warts History of severe allergic reaction that required medical intervention Received immune globulin or blood-derived products in the past 6 months or plan to receive any before Month 7 of the study History of splenectomy, is currently immunocompromised, or has been diagnosed with immunodeficiency, Human Immunodeficiency Virus (HIV), lymphoma, leukemia, systemic lupus erythematosus, rheumatoid arthritis, juvenile rheumatoid arthritis, inflammatory bowel disease, or other autoimmune condition Received immunosuppressive therapy in the past year, excluding inhaled, nasal, or topical corticosteroids and certain regimens of systemic corticosteroids Known thrombocytopenia or coagulation disorder that would contraindicate intramuscular injections Ongoing alcohol or drug abuse within the past 12 months
    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
    http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
    IPD Sharing URL
    http://engagezone.msd.com/ds_documentation.php
    Citations:
    PubMed Identifier
    30797638
    Citation
    Mikamo H, Yamagishi Y, Murata S, Yokokawa R, Han SR, Wakana A, Sawata M, Tanaka Y. Efficacy, safety, and immunogenicity of a quadrivalent HPV vaccine in Japanese men: A randomized, Phase 3, placebo-controlled study. Vaccine. 2019 Mar 14;37(12):1651-1658. doi: 10.1016/j.vaccine.2019.01.069. Epub 2019 Feb 20.
    Results Reference
    result

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    Efficacy and Tolerability Study of V501 in Japanese Males (V501-122)

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