Healthy
Conditions
Brief summary
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.
Interventions
BIOLOGICALV350A
Vaccination administered via intramuscular injection
BIOLOGICALV350B
Vaccination administered via intramuscular injection
BIOLOGICALPlacebo
Vaccination administered via intramuscular injection
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
12 Years to 30 Years
Healthy volunteers
Yes
Inclusion criteria
The key inclusion criteria include but are not limited to the following: * Is in good health before randomization. * Has a body mass index between 18 and 38 kg/m\^2, inclusive, for adults 18-30; has a body mass index between 15 and 38 kg/m\^2, inclusive, for adolescents 12-17.
Exclusion criteria
The key
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with Solicited Injection Site Adverse Events (AEs) | Up to approximately 6 months | 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). |
| Number of Participants with Solicited Systemic AEs | Up to approximately 6 months | 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. |
| Number of Participants with Immediate AEs Following Vaccinations | Up to approximately 6 months | 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. |
| Number of Participants with Unsolicited AEs | Up to approximately 7 months | 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. |
| Number of Participants with Serious AEs | Up to approximately 18 months | 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. |
| Number of Participants with Medically Attended Adverse Events (MAAEs) | Up to approximately 18 months | 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. |
| Number of Participants with Events of Clinical Interest (ECIs) | Up to approximately 18 months | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Geometric Mean Titers (GMT) of Immunoglobulin G (IgG) Antibodies Response Against Vaccine-matched Epstein Barr Virus (EBV) Antigens | Up to approximately 18 months | The GMT of EBV antigen antibody titers will be measured with a multiplex ligand binding assay (LBA). |
| Geometric Mean Fold Rise (GMFR) of IgG Antibody Response against Vaccine-matched EBV Antigens | Baseline and up to approximately 18 months | The GMFR of EBV antigen antibody titers will be measured with a multiplex LBA. |
Countries
United States
Contacts
CONTACTToll Free Number
STUDY_DIRECTORMedical Director
Merck Sharp & Dohme LLC
Outcome results
None listed