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Trial record 6 of 17 for:    condyloma | Recruiting, Not yet recruiting, Available Studies

Efficacy, Immunogenicity, and Safety Study of the 9vHPV Vaccine in Japanese Males (V503-064)

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ClinicalTrials.gov Identifier: NCT04635423
Recruitment Status : Recruiting
First Posted : November 19, 2020
Last Update Posted : February 8, 2021
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Tracking Information
First Submitted Date  ICMJE November 5, 2020
First Posted Date  ICMJE November 19, 2020
Last Update Posted Date February 8, 2021
Actual Study Start Date  ICMJE November 30, 2020
Estimated Primary Completion Date January 30, 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 13, 2020)
  • Combined incidence of HPV 6/11/16/18-related anogenital persistent infection [ Time Frame: Up to 42 months ]
    This endpoint is defined to have occurred in a participant 1) who is polymerase chain reaction (PCR) positive to HPV 6, 11, 16 or 18 in 2 consecutive anogenital or biopsy samples from at least 2 consecutive visits 6 months (+/- 1-month visit window) or longer apart, or 2) who has a pathology diagnosis of condyloma, penile/perineal/perianal intraepithelial neoplasia, or penile, perineal or perianal cancer and PCR detection of HPV 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 this endpoint is assessed in each treatment arm.
  • Percentage of participants with solicited injection-site adverse events (AEs) [ Time Frame: Up to 5 days after injection ]
    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
  • Percentage of participants with ≥1 systemic AE [ Time Frame: Up to 15 days after injection ]
    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
  • Percentage of participants with ≥1 serious adverse events (SAEs) [ Time Frame: Up to 6 months postdose 3 (up to 12 months) ]
    An SAE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention, that results in death, is life-threatening, requires hospitalization or prolongs existing hospitalization, results in persistent/significant disability/incapacity, is a congenital birth defect, or is an other important medical event.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 13, 2020)
  • Combined incidence of HPV 31/33/45/52/58-related anogenital persistent infection [ Time Frame: Up to 42 months ]
    This endpoint is defined to have occurred in a participant 1) who is PCR positive to HPV 31, 33, 45, 52, or 58 in 2 consecutive anogenital or biopsy samples from at least 2 consecutive visits 6 months (+/- 1-month visit window) or longer apart, or 2) who has a pathology diagnosis of condyloma, penile/perineal/perianal intraepithelial neoplasia, or penile, perineal or perianal cancer and PCR detection of HPV 31, 33, 45, 52, or 58 in an adjacent section and PCR positive for the same HPV type at a separate adjacent visit. The incidence of this endpoint is assessed in each treatment arm.
  • Geometric mean titers (GMTs) to HPV 6/11/16/18/31/33/45/52/58 [ Time Frame: Month 7 ]
    Serum antibody titers are measured with a competitive Luminex immunoassay (cLIA).
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy, Immunogenicity, and Safety Study of the 9vHPV Vaccine in Japanese Males (V503-064)
Official Title  ICMJE A Phase 3, Randomized, Placebo-controlled Clinical Study to Evaluate the Efficacy, Immunogenicity and Safety of the 9vHPV Vaccine in Japanese Males, 16 to 26 Years of Age.
Brief Summary The purposes of this phase 3, double-blind, placebo-controlled clinical study are to evaluate the efficacy of V503 (9-valent human papillomavirus [9vHPV] vaccine) in preventing HPV-related anogenital persistent infection, and to evaluate the safety/tolerability of V503, in Japanese males who are 16 to 26 years of age. It is hypothesized that administration of a 3-dose regimen of V503 reduces the combined incidence of HPV 6/11/16/18-related anogenital persistent infection, as well as the combined incidence of HPV 31/33/45/52/58-related anogenital persistent infection, compared with placebo.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE
  • Warts, Genital
  • Neoplasms, Anal
Intervention  ICMJE
  • Biological: V503
    9-valent vaccine, HPV 6/11/16/18/31/33/45/52/58, L1 virus-like particle (VLP) 30/40/60/40/20/20/20/20/20 mcg per dose.
    Other Names:
    • 9vHPV vaccine
    • SILGARD®9
    • GARDASIL™9
  • Other: Placebo
    0.9% sodium chloride (NaCL)
Study Arms  ICMJE
  • Experimental: V503
    Participants receive an intramuscular (IM) injection of V503 at Day 1, Month 2, and Month 6.
    Intervention: Biological: V503
  • Placebo Comparator: Placebo
    Participants receive an IM injection of placebo at Day 1, Month 2, and Month 6.
    Intervention: Other: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 13, 2020)
1050
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 30, 2025
Estimated Primary Completion Date January 30, 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Is a Japanese male 16 to 26 years of age
  • Has no more than 5 lifetime sexual partners

Exclusion Criteria:

  • Has a history of known prior vaccination with an HPV vaccine or plans to receive one outside the study
  • Has a history of external genital warts
  • Has a history of severe allergic reaction that required medical intervention
  • Has received immune globulin or blood-derived products in the past 3 months or plan to receive any before Month 7 of the study
  • Has a 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
  • Has received immunosuppressive therapy in the past year, excluding inhaled, nasal, or topical corticosteroids and certain regimens of systemic corticosteroids
  • Has a known thrombocytopenia or coagulation disorder that would contraindicate intramuscular injections
  • Has ongoing alcohol or drug abuse within the past 12 months
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Gender Based Eligibility: Yes
Ages  ICMJE 16 Years to 26 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Toll Free Number 1-888-577-8839 Trialsites@merck.com
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04635423
Other Study ID Numbers  ICMJE V503-064
2020-001047-67 ( EudraCT Number )
V503-064 ( Other Identifier: Merck Protocol Number )
jRCT2031200217 ( Registry Identifier: jRCT )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
URL: http://engagezone.msd.com/ds_documentation.php
Responsible Party Merck Sharp & Dohme Corp.
Study Sponsor  ICMJE Merck Sharp & Dohme Corp.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Director Merck Sharp & Dohme Corp.
PRS Account Merck Sharp & Dohme Corp.
Verification Date February 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP