NCT06623409PHASE1RecruitingAccepts Healthy Volunteers

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

Merck Sharp & Dohme LLC

Start Date

11/12/2024

Completion Date

5/31/2028

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

Age Range: 18 years to 45 years

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 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 prostatic intraepithelial neoplasia (PIN)) or external genital cancer (eg, penile cancer), HPV-related vaginal or anal lesions (eg, condyloma acuminata or vaginal intraepithelial 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 the study, outside the protocol.

Interventions

BIOLOGICAL

GARDASIL®9 (G9)

BIOLOGICAL

V540B

Interested in This Trial?

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Conditions

Healthy

Locations

Anaheim Clinical Trials ( Site 0002)

Anaheim, California 92801

United States

Velocity Clinical Research, Hallandale Beach ( Site 0003)

Hallandale, Florida 33009

United States

Research Centers of America ( Hollywood ) ( Site 0001)

Hollywood, Florida 33024

United States

Velocity Clinical Research, Omaha ( Site 0005)

Omaha, Nebraska 68134

United States