RecruitingPhase 1NCT06623409

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

A Phase 1, Randomized, Double-Blind, Comparator-Controlled, Dose-Escalation Study to Evaluate the Safety, Tolerability, and Immunogenicity of V540B in Healthy Adults.


Sponsor

Merck Sharp & Dohme LLC

Enrollment

72 participants

Start Date

Nov 12, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 45 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a biological treatment called GARDASIL®9 (G9) and a biological treatment called V540B for people with healthy. The study is currently recruiting participants at 5 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALGARDASIL®9 (G9)

Suspension administered via intramuscular (IM) injection

BIOLOGICALV540B

Experimental vaccine and adjuvant administered via IM injection


Locations(5)

Anaheim Clinical Trials ( Site 0002)

Anaheim, California, United States

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

Glendale, California, United States

Velocity Clinical Research, Hallandale Beach ( Site 0003)

Hallandale, Florida, United States

Research Centers of America ( Hollywood ) ( Site 0001)

Hollywood, Florida, United States

Velocity Clinical Research, Omaha ( Site 0005)

Omaha, Nebraska, United States

View Full Details on ClinicalTrials.gov

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NCT06623409


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