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

Last updated: October 30, 2018
Sponsor: Merck Sharp & Dohme Corp.
Overall Status: Completed

Phase

3

Condition

Genital Warts

Genitourinary Cancer

Sexually Transmitted Diseases (Stds)

Treatment

N/A

Clinical Study ID

NCT01651949
V503-003
2012-002758-22
  • Ages 16-26
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Good physical health

  • Has never had Papanicolaou testing (Pap, cervical or anal) or has only had normal Paptest results

  • Other inclusion criteria will be discussed with the investigator

Exclusion

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 lastyear

  • Positive test for HPV

  • History of HPV-related external genital lesions or HPV-related anal lesions or analcancer

  • If participant is female, history of abnormal cervical biopsy results

  • Other exclusion criteria will be discussed with the investigator

Study Design

Total Participants: 2520
Study Start date:
October 29, 2012
Estimated Completion Date:
August 04, 2014

Study 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.

Connect with a study center

  • Merck Canada

    Kirkland, Quebec H9H 3L1
    Canada

    Site Not Available

  • MDS Colombia SAS

    Bogota, Cundinamarca
    Colombia

    Site Not Available

  • Merck Sharp & Dohme

    Glostrup, DK 2600
    Denmark

    Site Not Available

  • Merck Sharp & Dohme GmbH

    Haar,
    Germany

    Site Not Available

  • Merck Sharp & Dohme Co. Ltd.

    Hod Hasharon, Petach Tikva 45240
    Israel

    Site Not Available

  • MSD

    Petaling Jaya, 46100
    Malaysia

    Site Not Available

  • MSD

    Mexico City,
    Mexico

    Site Not Available

  • MSD Norge A/S

    Drammen,
    Norway

    Site Not Available

  • Merck Sharp & Dohme, Peru S.R.L.

    Lima,
    Peru

    Site Not Available

  • Merck Sharp & Dohme (I.A.) Corporation

    Makati,
    Philippines

    Site Not Available

  • MSD Polska Sp. Z o.o.

    Warsaw,
    Poland

    Site Not Available

  • MSD Polska Sp. Z o.o.

    Warszawa, 00-867
    Poland

    Site Not Available

  • MSD (Pty) LTD South Africa

    Midrand,
    South Africa

    Site Not Available

  • Merck Sharp and Dohme de Espana S.A.

    Madrid, 28027
    Spain

    Site Not Available

  • MSD

    Sollentuna, 192 07
    Sweden

    Site Not Available

  • MSD (Thailand) Ltd.

    Bangkok,
    Thailand

    Site Not Available

  • Merck Sharp & Dohme Ilaclari Ltd. Sti

    Istanbul,
    Turkey

    Site Not Available

  • Call for Information (Investigational Site 0238)

    Alhambra, California 91801
    United States

    Site Not Available

  • Call for Information (Investigational Site 0236)

    Roseville, California 95661
    United States

    Site Not Available

  • Call for Information (Investigational Site 0263)

    San Francisco, California 94118
    United States

    Site Not Available

  • Call for Information (Investigational Site 0237)

    Spring Valley, California 91978
    United States

    Site Not Available

  • Call for Information (Investigational Site 0250)

    Coral Gables, Florida 33134
    United States

    Site Not Available

  • Call for Information (Investigational Site 0248)

    Miami, Florida 33135
    United States

    Site Not Available

  • Call for Information (Investigational Site 0247)

    South Miami, Florida 33143
    United States

    Site Not Available

  • Call for Information (Investigational Site 0026)

    Tampa, Florida 33617
    United States

    Site Not Available

  • Call for Information (Investigational Site 0230)

    Chicago, Illinois 60612
    United States

    Site Not Available

  • Call for Information (Investigational Site 0233)

    Indianapolis, Indiana 46202
    United States

    Site Not Available

  • Call for Information (Investigational Site 0228)

    Bardstown, Kentucky 40004
    United States

    Site Not Available

  • Call for Information (Investigational Site 0249)

    Marrero, Louisiana 70072
    United States

    Site Not Available

  • Call for Information (Investigational Site 0242)

    Elkridge, Maryland 21075
    United States

    Site Not Available

  • Call for Information (Investigational Site 0229)

    Kansas City, Missouri 64114
    United States

    Site Not Available

  • Call for Information (Investigational Site 0264)

    New York, New York 10011
    United States

    Site Not Available

  • Call for Information (Investigational Site 0241)

    Rochester, New York 14609
    United States

    Site Not Available

  • Call for Information (Investigational Site 0231)

    Cincinnati, Ohio 45227
    United States

    Site Not Available

  • Call for Information (Investigational Site 0025)

    Philadelphia, Pennsylvania 19107
    United States

    Site Not Available

  • Call for Information (Investigational Site 0244)

    Providence, Rhode Island 02906
    United States

    Site Not Available

  • Call for Information (Investigational Site 0232)

    Nashville, Tennessee 37203
    United States

    Site Not Available

  • Call for Information (Investigational Site 0255)

    Galveston, Texas 77555-0315
    United States

    Site Not Available

  • Call for Information (Investigational Site 0235)

    Salt Lake City, Utah 84121
    United States

    Site Not Available

  • Call for Information (Investigational Site 0245)

    Richmond, Virginia 23233
    United States

    Site Not Available

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