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Cancer Vaccine
V540B Vaccine for HPV Prevention
Hallandale Beach, FL
Phase 1
Recruiting
Research Sponsored by Merck Sharp & Dohme LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
* Is in good health based on medical history, physical examination, vital sign (VS) measurements and electrocardiograms (ECGs) performed before randomization.
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 18 months
Awards & highlights
No Placebo-Only Group
Summary
"This trial is looking for new ways to prevent cancers caused by the human papillomavirus (HPV). They are testing a new vaccine, called V540B, that is designed to protect against
See full description
Who is the study for?
This trial is for healthy adults who are in good health as determined by their medical history, physical exams, vital sign measurements, and ECGs performed before randomization. Specific details on age or other factors aren't provided.Check my eligibility
What is being tested?
The study is testing a new vaccine called V540B designed to prevent HPV-related cancers. It aims to protect against more types of HPV than the existing GARDASIL®9 (G9) vaccine. The main focus is on safety and tolerability in healthy adults.See study design
What are the potential side effects?
While specific side effects are not listed here, typical vaccine side effects may include pain at the injection site, fatigue, headache, muscle or joint pain, fever, chills or nausea.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
* Is in good health based on medical history, physical examination, vital sign (VS) measurements and electrocardiograms (ECGs) performed before randomization.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to approximately 18 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 18 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Immediate Reactions Occurring Within 30 Minutes After Any Vaccination
Number of Participants Who Experience a Solicited Injection-Site Adverse Event (AE)
Number of Participants Who Experience a Solicited Systemic AE
+4 moreSecondary study objectives
Total Immunoglobulin G (IgG) Geometric Mean Ratios (GMRs) for anti-HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: V540BExperimental Treatment1 Intervention
Participants will receive vaccinations with V540B.
Group II: GARDASIL®9 (G9)Active Control1 Intervention
Participants will receive vaccinations with G9.
Find a Location
Closest Location:Velocity Clinical Research, Omaha ( Site 0005)· Omaha, NE· 263 miles
Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
Merck Sharp & Dohme LLCLead Sponsor
4,086 Previous Clinical Trials
5,223,845 Total Patients Enrolled
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,965 Previous Clinical Trials
8,098,729 Total Patients Enrolled