A Study of V330 in Healthy Younger (18 to 49 Years Inclusive) and Healthy Older (60 to 79 Years Inclusive) Participants (V330-001)
- Registration Number
- NCT06630117
- Lead Sponsor
- Merck Sharp & Dohme LLC
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 245
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
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Dose Escalation Panel A Placebo 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 C V330 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 V330 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 Escalation Panel B Placebo 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 Placebo 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 Placebo 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 Placebo 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 Escalation Panel F Placebo 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 Placebo 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 V330 Participants 60 to 79 years old will be randomized to receive V330 DL 6 or placebo via intramuscular injection on Day 1. Dose Escalation Panel H Placebo 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 Placebo 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 Placebo 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 Placebo 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 Placebo Participants 60 to 79 years old will be randomized to receive V330 DL 2 or placebo via intramuscular injection on Day 1. Dose Expansion Panel J Placebo 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 G1 Placebo 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 V330 Participants 60 to 79 years old will be randomized to receive V330 DL 4 or placebo via intramuscular injection on Day 1. Dose Escalation Panel H1 Placebo Participants 60 to 79 years old will be randomized to receive V330 DL 4 or placebo via intramuscular injection on Day 1. Dose Expansion Panel E V330 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 Escalation Panel F V330 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 B1 V330 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 G V330 Participants 60 to 79 years old will be randomized to receive V330 DL 3 or placebo via intramuscular injection on Day 1. Dose Expansion Panel I V330 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 V330 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 V330 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 F1 V330 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 A V330 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 V330 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 G1 V330 Participants 60 to 79 years old will be randomized to receive V330 DL 5 or placebo via intramuscular injection on Day 1.
- Primary Outcome Measures
Name Time Method 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.
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 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.
- Secondary Outcome Measures
Name Time Method 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.
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.
Trial Locations
- Locations (4)
California Clinical Trials Medical Group managed by PAREXEL ( Site 0002)
🇺🇸Glendale, California, United States
Velocity Clinical Research, Hallandale Beach ( Site 0003)
🇺🇸Hallandale Beach, Florida, United States
Research Centers of America ( Hollywood ) ( Site 0004)
🇺🇸Hollywood, Florida, United States
QPS-MRA, LLC-Early Phase ( Site 0006)
🇺🇸South Miami, Florida, United States