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

  • STATUS
    Recruiting
  • End date
    Jan 30, 2025
  • participants needed
    1050
  • sponsor
    Merck Sharp & Dohme Corp.
Updated on 19 July 2021

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.

Details
Condition Condyloma acuminatum, Anal Cancer, Genital Warts
Treatment Placebo, V503
Clinical Study IdentifierNCT04635423
SponsorMerck Sharp & Dohme Corp.
Last Modified on19 July 2021

Eligibility

Yes No Not Sure

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
Clear my responses

How to participate?

Step 1 Connect with a site
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar
Name

Primary Contact

site
Name

0/250
Preferred Language
Other Language
Please verify that you are not a bot.

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note