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
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose Escalation Panel A | Experimental | Participants 18 to 49 years old will be randomized to receive V330 dose level (DL) 1 or placebo via intramuscular injection on Day 1 and Day 57. |
|
| Dose Escalation Panel B | Experimental | Participants 18 to 49 years old will be randomized to receive V330 DL 3 or placebo via intramuscular injection on Day 1 and Day 57. |
|
| Dose Escalation Panel C | Experimental | Participants 18 to 49 years old will be randomized to receive V330 DL 6 or placebo via intramuscular injection on Day 1 and Day 57. |
|
| Dose Expansion Panel D | Experimental | Participants 18 to 49 years old will be randomized to receive a selected dose of V330 at less than or equal to DL 6 or placebo via intramuscular injection on Day 1. |
|
| Dose Expansion Panel E | Experimental | Participants 18 to 49 years old will be randomized to receive a selected dose of V330 at less than or equal to DL 6 or placebo via intramuscular injection on Day 1. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| V330 | Biological | Intramuscular injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Solicited Injection Site Adverse Events (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 injection site AEs will be recorded on a vaccination report card (VRC). | Up to approximately 7 days after each vaccination |
| 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 7 days after each vaccination |
| Number of Participants with Solicited Local AEs of Axillary Lymphadenopathy | 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. | Up to approximately 28 days after each vaccination |
| 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 30 minutes after each vaccination |
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Geometric Mean Titers (GMT) of Histo-Blood Group Antigen (HBGA) Blocking Antibodies Against Vaccine-matched Norovirus (NoV) Genotypes | The GMT of virus like particle (VLP) serum antibody titers measured by HBGA blocking assay will be determined. | Up to 28 days post vaccination |
| GMT of IgG Antibodies Response Against Vaccine-matched NoV Genotypes |
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
Not provided
| 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 0002) | 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
|
| Dose Escalation Panel F | Experimental | Participants 60 to 79 years old will be randomized to receive V330 DL 1 or placebo via intramuscular injection on Day 1. |
|
| Dose Escalation Panel G | Experimental | Participants 60 to 79 years old will be randomized to receive V330 DL 3 or placebo via intramuscular injection on Day 1. |
|
| Dose Escalation Panel H | Experimental | Participants 60 to 79 years old will be randomized to receive V330 DL 6 or placebo via intramuscular injection on Day 1. |
|
| Dose Expansion Panel I | Experimental | Participants 60 to 79 years old will be randomized to receive a selected dose of V330 at less than or equal to DL 6 or placebo via intramuscular injection on Day 1. |
|
| Dose Expansion Panel J | Experimental | Participants 60 to 79 years old will be randomized to receive a selected dose of V330 at less than or equal to DL 6 or placebo via intramuscular injection on Day 1. |
|
| Dose Escalation Panel A1 | Experimental | Participants 18 to 49 years old will be randomized to receive V330 DL 2 or placebo via intramuscular injection on Day 1. |
|
| Dose Escalation Panel B1 | Experimental | Participants 18 to 49 years old will be randomized to receive V330 DL 5 or placebo via intramuscular injection on Day 1. |
|
| Dose Escalation Panel F1 | Experimental | Participants 60 to 79 years old will be randomized to receive V330 DL 2 or placebo via intramuscular injection on Day 1. |
|
| Dose Escalation Panel G1 | Experimental | Participants 60 to 79 years old will be randomized to receive V330 DL 5 or placebo via intramuscular injection on Day 1. |
|
| Dose Escalation Panel H1 | Experimental | Participants 60 to 79 years old will be randomized to receive V330 DL 4 or placebo via intramuscular injection on Day 1. |
|
| Placebo | Biological | Intramuscular injection |
|
| Up to approximately 28 days after each vaccination |
| 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. | Up to approximately 6 months after final vaccination |
| 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 6 months after final vaccination |
| Number of Participants with Events of Clinical Interest (ECIs) | 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. | Up to approximately 6 months after final vaccination |
The GMT of VLP serum antibody titers measured by IgG immunoassay will be determined. |
| Up to 28 days post vaccination |
| Velocity Clinical Research, Hallandale Beach ( Site 0003) |
| Hallandale |
| Florida |
| 33009 |
| United States |
| Research Centers of America ( Hollywood ) ( Site 0004) | Hollywood | Florida | 33024 | United States |
| QPS-MRA, LLC-Early Phase ( Site 0006) | South Miami | Florida | 33143 | United States |