A Trial to Evaluate Tolerability and Immunogenicity of V540D in Healthy Adults (V540D-004)
- Registration Number
- NCT06688058
- Lead Sponsor
- Merck Sharp & Dohme LLC
- 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 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 72
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
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
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description V540D V540D Participants will receive vaccinations with V540D. GARDASIL®9 GARDASIL®9 Participants will receive vaccinations with GARDASIL®9.
- Primary Outcome Measures
Name Time Method Number of Participants Who Experience a Solicited Injection-Site Adverse Event (AE) Up to approximately 6 months An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Number of Participants Who Experience a Solicited Systemic AE Up to approximately 6 months Solicited systemic AEs include headache, fatigue, nausea, dizziness, muscle aches, joint pain.
Number of Participants Who Experience Immediate Reactions Occurring Within 30 Minutes After Any Vaccination Up to approximately 6 months An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Number of Participants Who Experience Unsolicited AEs Up to approximately 7 months An unsolicited AE is an event that is not predefined as a solicited AE or is predefined as a solicited AE but reported at any time outside the solicited time period.
Number of Participants Who Experience a Serious Adverse Event (SAE) Up to approximately 18 months SAEs include AEs that result in any of the following outcomes: death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal functions, or a congenital anomaly/birth defect.
Number of Participants Who Experience a Medically-Attended AE (MAAE) Up to approximately 18 months AEs in which medical attention is received during an unscheduled, non-routine outpatient visit, such as an emergency department visit, office visit, or an urgent care visit with any medical personnel for any reason. Routine visits are not considered MAAEs. Examples of routine visits include physical examination, wellness visits, or vaccinations.
Number of Participants Who Experience an Event of Clinical Interest (ECI) Up to approximately 18 months ECIs are defined as an overdose of Sponsor's product, drug-induced liver injury events, or potential immune-mediated diseases (pIMDs).
- Secondary Outcome Measures
Name Time Method Total Immunoglobulin G (IgG) Geometric Mean Ratios (GMRs) for anti-HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58 Up to approximately 7 months GMR of titers for participants vaccinated with V540D versus those who received GARDASIL®9 alone will be calculated.
Trial Locations
- Locations (4)
Alliance for Multispecialty Research, LLC ( Site 0003)
🇺🇸Kansas City, Missouri, United States
Alliance for Multispecialty Research, LLC ( Site 0004)
🇺🇸Knoxville, Tennessee, United States
Velocity Clinical Research, Savannah ( Site 0005)
🇺🇸Savannah, Georgia, United States
Research Centers of America ( Hollywood ) ( Site 0001)
🇺🇸Hollywood, Florida, United States