Recruiting
Phase 1

V540B

Sponsor:

Merck Sharp & Dohme LLC

Code:

NCT06623409

Conditions

Healthy

Eligibility Criteria

Sex: All

Age: 18 - 45

Healthy Volunteers: Accepted

Interventions

GARDASIL®9 (G9)

V540B

Study Details

Brief 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.

Conditions

Healthy

Study ID

NCT06623409

Start date

Nov 12, 2024

Status verified date

Aug, 2026

Completion date

May 31, 2028

Anticipated

Primary completion date

May 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 45

Healthy Volunteers: Accepted

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

Enrollment

72 participants

Anticipated

Allocation

Randomized

Intervention Model

Sequential

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

active comparator: GARDASIL®9 (G9)

Participants will receive vaccinations with G9.

experimental: V540B

Participants will receive vaccinations with V540B.

Interventions

GARDASIL®9 (G9)

Suspension administered via intramuscular (IM) injection

V540B

Experimental vaccine and adjuvant administered via IM injection

Primary outcome measure

  • Number of Participants Who Experience a Solicited Injection-Site Adverse Event (AE) [ Time Frame: Up to approximately 6 months ]
  • Number of Participants Who Experience a Solicited Systemic AE [ Time Frame: Up to approximately 6 months ]
  • Immediate Reactions Occurring Within 30 Minutes After Any Vaccination [ Time Frame: Up to approximately 6 months ]
  • Number of Participants Who Experienced Unsolicited AEs [ Time Frame: Up to approximately 7 months ]
  • Number of Participants Who Experienced a Serious Adverse Event [ Time Frame: Up to approximately 18 months ]
  • Number of Participants Who Experienced a Medically-Attended AE [ Time Frame: Up to approximately 18 months ]
  • Number of Participants Who Experienced an Event of Clinical Interest [ Time Frame: Up to approximately 18 months ]

Central Contacts and Locations

Central contacts

Toll Free Number

1-888-577-8839Trialsites@msd.com

Locations

Research Centers of America ( Hollywood ) ( Site 0001)

Recruiting

Hollywood, Florida, United States, 33024

Contacts

Study Coordinator

954-324-4706

More Information

Sponsor

Merck Sharp & Dohme LLC

Last update posted

Sep 2, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Merck Sharp & Dohme LLC on 2026-09-02.