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Purpose

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.

Condition

Eligibility

Eligible Ages
Between 18 Years and 45 Years
Eligible Sex
All
Accepts Healthy Volunteers
Yes

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.

Study Design

Phase
Phase 1
Study Type
Interventional
Allocation
Randomized
Intervention Model
Sequential Assignment
Primary Purpose
Prevention
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Active Comparator
GARDASIL®9 (G9) 		Participants will receive vaccinations with G9.
  • Biological: GARDASIL®9 (G9)
    Suspension administered via intramuscular (IM) injection
    Other names:
    • V503
Experimental
V540B 		Participants will receive vaccinations with V540B.
  • Biological: V540B
    Experimental vaccine and adjuvant administered via IM injection

Recruiting Locations

Anaheim Clinical Trials ( Site 0002)
Anaheim, California 92801
Contact:
Study Coordinator
714-774-7777

Velocity Clinical Research, Hallandale Beach ( Site 0003)
Hallandale, Florida 33009
Contact:
Study Coordinator
954-455-5757

Research Centers of America ( Hollywood ) ( Site 0001)
Hollywood, Florida 33024
Contact:
Study Coordinator
954-324-4706

Velocity Clinical Research, Omaha ( Site 0005)
Omaha, Nebraska 68134
Contact:
Study Coordinator
402-933-6500

More Details

Status
Recruiting
Sponsor
Merck Sharp & Dohme LLC

Study Contact

Toll Free Number
1-888-577-8839
Trialsites@msd.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.