Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Epstein Barr virus (EBV) is a virus which can cause infectious mononucleosis and is associated with certain kinds of cancer and multiple sclerosis. Researchers are looking for new ways to prevent disease related to EBV and have developed a new study vaccine (V350A and V350B). The main goal of this study is to learn about the safety and tolerability of V350A and V350B in healthy adults.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| V350A | Experimental | Participants will receive V350A vaccinations on Day 1, Month 2, and Month 6. |
|
| V350B | Experimental | Participants will receive V350B vaccinations on Day 1, Month 2, and Month 6. |
|
| Placebo | Placebo Comparator | Participants will receive placebo vaccinations on Day 1, Month 2, and Month 6. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| V350A | Biological | Vaccination administered via intramuscular injection |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Solicited Injection Site Adverse Events (AEs) | An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Solicited injection site AEs will be recorded on a vaccination report card (VRC). | Up to approximately 6 months |
| Number of Participants with Solicited Systemic AEs | An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Solicited systemic AEs will be recorded on a VRC. | Up to approximately 6 months |
| Number of Participants with Immediate AEs Following Vaccinations | An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Participants will be observed following vaccination for immediate AEs. | Up to approximately 6 months |
| Number of Participants with Unsolicited AEs | An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Unsolicited AEs will be recorded on a VRC. | Up to approximately 7 months |
| Number of Participants with Serious AEs | A serious adverse event (SAE) is an AE that results in death, is life threatening, results in a persistent or significant disability or incapacity, results in or prolongs an existing hospitalization, is a congenital anomaly or birth defect, is a cancer, is an overdose, or is another important medical event. |
| Measure | Description | Time Frame |
|---|---|---|
| Geometric Mean Titers (GMT) of Immunoglobulin G (IgG) Antibodies Response Against Vaccine-matched Epstein Barr Virus (EBV) Antigens | The GMT of EBV antigen antibody titers will be measured with a multiplex ligand binding assay (LBA). | Up to approximately 18 months |
| Geometric Mean Fold Rise (GMFR) of IgG Antibody Response against Vaccine-matched EBV Antigens |
Not provided
Inclusion Criteria:
The key inclusion criteria include but are not limited to the following:
Exclusion Criteria:
The key exclusion criteria include but are not limited to the following:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Toll Free Number | Contact | 1-888-577-8839 | Trialsites@msd.com |
| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| California Clinical Trials Medical Group managed by PAREXEL ( Site 0011) | Completed | Glendale | California | 91206 | United States |
Not provided
| Label | URL |
|---|---|
| Merck Clinical Trials Information | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| V350B |
| Biological |
Vaccination administered via intramuscular injection |
|
| Placebo | Biological | Vaccination administered via intramuscular injection |
|
| Up to approximately 18 months |
| Number of Participants with Medically Attended Adverse Events (MAAEs) | A MAAE is an AE 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. | Up to approximately 18 months |
| Number of Participants with Events of Clinical Interest (ECIs) | ECIs are selected serious and nonserious AEs are defined as an overdose of Sponsor's product, drug-induced liver injury events, or potential immune-mediated diseases (pIMDs). | Up to approximately 18 months |
The GMFR of EBV antigen antibody titers will be measured with a multiplex LBA. |
| Baseline and up to approximately 18 months |
| QPS-MRA, LLC ( Site 0012) | Active, not recruiting | South Miami | Florida | 33143 | United States |
| Alliance for Multispecialty Research, LLC ( Site 0008) | Recruiting | Kansas City | Missouri | 64114 | United States |
|
| Bio-Kinetic Clinical Applications, LLC dba QPS-MO ( Site 0016) | Recruiting | Springfield | Missouri | 65802 | United States |
|
| Velocity Clinical Research Lincoln ( Site 0004) | Recruiting | Lincoln | Nebraska | 68510 | United States |
|
| Velocity Clinical Research, Omaha ( Site 0005) | Active, not recruiting | Omaha | Nebraska | 68134 | United States |
| Remington-Davis, Inc. ( Site 0017) | Recruiting | Columbus | Ohio | 43215 | United States |
|
| Lynn Health Science Institute ( Site 0010) | Recruiting | Oklahoma City | Oklahoma | 73112 | United States |
|
| Alliance for Multispecialty Research, LLC ( Site 0009) | Active, not recruiting | Knoxville | Tennessee | 37909 | United States |