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Trial record 6 of 15 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.

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.

Condition or disease Intervention/treatment Phase
Warts, Genital Neoplasms, Anal Biological: V503 Other: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1050 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: 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.
Actual Study Start Date : November 30, 2020
Estimated Primary Completion Date : January 30, 2025
Estimated Study Completion Date : January 30, 2025

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: V503
Participants receive an intramuscular (IM) injection of V503 at Day 1, Month 2, and Month 6.
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

Placebo Comparator: Placebo
Participants receive an IM injection of placebo at Day 1, Month 2, and Month 6.
Other: Placebo
0.9% sodium chloride (NaCL)




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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).



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Ages Eligible for Study:   16 Years to 26 Years   (Child, Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04635423


Contacts
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Contact: Toll Free Number 1-888-577-8839 Trialsites@merck.com

Locations
Show Show 22 study locations
Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
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Study Director: Medical Director Merck Sharp & Dohme Corp.
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Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT04635423    
Other Study ID Numbers: V503-064
2020-001047-67 ( EudraCT Number )
V503-064 ( Other Identifier: Merck Protocol Number )
jRCT2031200217 ( Registry Identifier: jRCT )
First Posted: November 19, 2020    Key Record Dates
Last Update Posted: February 8, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
URL: http://engagezone.msd.com/ds_documentation.php

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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
Additional relevant MeSH terms:
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Condylomata Acuminata
Anus Neoplasms
Warts
Papillomavirus Infections
DNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Skin Diseases, Viral
Tumor Virus Infections
Skin Diseases, Infectious
Skin Diseases
Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Anus Diseases
Rectal Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs