Safety and Immunogenicity of V540B in Healthy Adults (V540B-002).

Last updated: May 12, 2025
Sponsor: Merck Sharp & Dohme LLC
Overall Status: Active - Recruiting

Phase

1

Condition

N/A

Treatment

GARDASIL®9 (G9)

V540B

Clinical Study ID

NCT06623409
V540B-002
V540B-002
  • Ages 18-45
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

Researchers are looking for new ways to prevent cancers related to human papillomavirus (HPV). HPV is a common virus that can cause an infection. There are many different types of HPV. Most people's immune system can fight HPV infection and it goes away without treatment. For some people, HPV infections can last longer and may cause cancer years later.

A standard vaccine to prevent HPV-related cancers is GARDASIL®9 (G9). G9 protects against 9 types of HPV but it does not protect against other types of HPV. The study vaccine (called V540B) is designed to protect against the same HPV types that G9 protects against plus other HPV types. The main goal of this study is to learn about the safety of V540B in healthy adults and if people tolerate it.

Eligibility Criteria

Inclusion

Inclusion Criteria:

The key inclusion criteria include but are not limited to the following:

  • Is in good health based on medical history, physical examination, vital sign (VS)measurements and electrocardiograms (ECGs) performed before randomization.

Exclusion

Exclusion Criteria:

The key exclusion criteria include but are not limited to the following:

  • Has a history of abnormal Pap smears, HPV- related external genital lesions (eg,condyloma acuminate, vulval intraepithelial neoplasia (VIN), or prostaticintraepithelial neoplasia (PIN)) or external genital cancer (eg, penile cancer),HPV-related vaginal or anal lesions (eg, condyloma acuminata or vaginalintraepithelial neoplasia (VaIN)) or vaginal or anal cancer.

  • Has a history of cancer (malignancy).

  • Has received any HPV vaccine or is expected to receive any HPV vaccine during thestudy, outside the protocol.

Study Design

Total Participants: 72
Treatment Group(s): 2
Primary Treatment: GARDASIL®9 (G9)
Phase: 1
Study Start date:
November 12, 2024
Estimated Completion Date:
November 20, 2026

Connect with a study center

  • Anaheim Clinical Trials ( Site 0002)

    Anaheim, California 92801
    United States

    Active - Recruiting

  • California Clinical Trials Medical Group managed by PAREXEL ( Site 0008)

    Glendale, California 91206
    United States

    Active - Recruiting

  • Velocity Clinical Research, Hallandale Beach ( Site 0003)

    Hallandale Beach, Florida 33009
    United States

    Active - Recruiting

  • Research Centers of America ( Hollywood ) ( Site 0001)

    Hollywood, Florida 33024
    United States

    Active - Recruiting

  • Velocity Clinical Research, Omaha ( Site 0005)

    Omaha, Nebraska 68134
    United States

    Active - Recruiting

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