Testing a new vaccine called V330 in healthy adults and older individuals
A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Dose Escalation Trial to Evaluate the Safety, Tolerability, and Immunogenicity of V330 in Healthy Younger (18 to 49 Years Inclusive) and Healthy Older Participants (60 to 79 Years Inclusive).
This study is testing a new vaccine called V330 in healthy adults aged 18 to 49 and older individuals aged 60 to 79 to see if it is safe and helps their immune systems produce antibodies.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 245 (estimated) |
| Ages | 18 Years to 79 Years |
| Sex | All |
| Sponsor | Merck Sharp & Dohme LLC Industry-sponsored |
| Locations | 4 sites (Glendale, California and 3 other locations) |
| Trial ID | NCT06630117 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the safety and immune response of a new vaccine, V330, in healthy participants aged 18 to 49 and 60 to 79 years. Participants will receive either the V330 vaccine or a placebo to assess how well their immune systems produce antibodies in response to the vaccine. The study is designed to gather important data on the vaccine's safety profile and its effectiveness in generating an immune response. The findings could provide insights into the potential use of V330 in broader populations.
Who should consider this trial
Good fit: Ideal candidates for this study are healthy adults aged 18 to 49 or older adults aged 60 to 79.
Not a fit: Patients with a history of myocarditis, pericarditis, myopericarditis, or cancer may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to the development of a new vaccine that enhances immune responses in healthy individuals.
How similar studies have performed: Other studies evaluating vaccine safety and immune response have shown success, indicating that this approach is well-established.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: The key inclusion criteria include but are not limited to the following: * Is in good health prior to randomization * Is an individual from 18 to 49 years of age inclusive or from 60 to 79 years of age inclusive Exclusion Criteria: The key exclusion criteria include but are not limited to the following: * Has a history of myocarditis, pericarditis, and/or myopericarditis * Has a history of cancer
Where this trial is running
Glendale, California and 3 other locations
- California Clinical Trials Medical Group managed by PAREXEL ( Site 0002) — Glendale, California, United States (Recruiting)
- Velocity Clinical Research, Hallandale Beach ( Site 0003) — Hallandale Beach, Florida, United States (Recruiting)
- Research Centers of America ( Hollywood ) ( Site 0004) — Hollywood, Florida, United States (Recruiting)
- QPS-MRA, LLC-Early Phase ( Site 0006) — South Miami, Florida, United States (Recruiting)
Study contacts
- Study coordinator: Toll Free Number
- Email: Trialsites@msd.com
- Phone: 1-888-577-8839
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.