Healthy
Conditions
Brief summary
The goal of this study is to learn whether a new vaccine, V330, is safe and learn how well the body's immune system responds by making antibodies after receiving V330.
Interventions
BIOLOGICALV330
Intramuscular injection
BIOLOGICALPlacebo
Intramuscular injection
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 79 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with Events of Clinical Interest (ECIs) | Up to approximately 6 months after final vaccination | ECIs are selected serious and nonserious AEs which include but are not limited to: 1) an elevated aspartate aminotransferase or alanine aminotransferase value greater than or equal to three times the upper limit of normal (ULN) and an elevated bilirubin value of greater than two times the ULN and, at the same time, an alkaline phosphatase value of less than two times the ULN, 2) an overdose of V330. |
| Number of Participants with Serious AEs | Up to approximately 6 months after final vaccination | 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 6 months after final vaccination | 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 Solicited Injection Site Adverse Events (AEs) | Up to approximately 7 days after each vaccination | 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 injection site AEs will be recorded on a vaccination report card (VRC). |
| Number of Participants with Solicited Systemic AEs | Up to approximately 7 days after each vaccination | 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 Solicited Local AEs of Axillary Lymphadenopathy | Up to approximately 28 days after each vaccination | 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 assessed for local AEs related to axillary lymphadenopathy. |
| Number of Participants with Immediate AEs Following Vaccinations | Up to approximately 30 minutes after each vaccination | 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 28 days after each vaccination | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| GMT of IgG Antibodies Response Against Vaccine-matched NoV Genotypes | Up to 28 days post vaccination | The GMT of VLP serum antibody titers measured by IgG immunoassay will be determined. |
| Geometric Mean Titers (GMT) of Histo-Blood Group Antigen (HBGA) Blocking Antibodies Against Vaccine-matched Norovirus (NoV) Genotypes | Up to 28 days post vaccination | The GMT of virus like particle (VLP) serum antibody titers measured by HBGA blocking assay will be determined. |
Countries
United States
Outcome results
None listed