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A Trial to Evaluate Tolerability and Immunogenicity of V540D in Healthy Adults (V540D-004)

A Trial to Evaluate Tolerability and Immunogenicity of V540D in Healthy Adults (V540D-004)

Recruiting
18-45 years
All
Phase 1

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Overview

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 V540D) 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 V540D in healthy adults and if people tolerate it.

Eligibility

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 details
    Healthy

NCT06688058

Merck Sharp & Dohme LLC

16 October 2025

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FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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