NCT06630117|CompletedPhase 1FDA Drug

A Study of V330 in Healthy Younger (18 to 49 Years Inclusive) and Healthy Older (60 to 79 Years Inclusive) Participants (V330-001)

A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Dose Escalation Trial to Evaluate the Safety, Tolerability, and Immunogenicity of V330 in Healthy Younger (18 to 49 Years Inclusive) and Healthy Older Participants (60 to 79 Years Inclusive).

Merck Sharp & Dohme LLC ClinicalTrials.gov

Compare

1 other identifier

V330-001

Study Type

interventional

Target

245

Locations

1 country

Sites

Timeline

RegisteredOct 2024

StartedMar 2024

CompletionOct 2025

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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

245

participants targeted

Target at P75+ for phase_1 healthy

Timeline

Completed

Started Mar 2024

Longer than P75 for phase_1 healthy

Geographic Reach

1 country

4 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

1.6 years study duration

Study Start

First participant enrolled

March 1, 2024

Completed

7 months until next milestone

First Submitted

Initial submission to the registry

October 3, 2024

Completed

5 days until next milestone

First Posted

Study publicly available on registry

October 8, 2024

Completed

1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 17, 2025

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 17, 2025

Completed

Last Updated

November 3, 2025

Status Verified

October 1, 2025

Enrollment Period

1.6 years

First QC Date

October 3, 2024

Last Update Submit

October 31, 2025

Conditions

Healthy

Outcome Measures

Primary Outcomes (8)

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.
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

Secondary Outcomes (2)

Geometric Mean Titers (GMT) of Histo-Blood Group Antigen (HBGA) Blocking Antibodies Against Vaccine-matched Norovirus (NoV) Genotypes
Up to 28 days post vaccination
GMT of IgG Antibodies Response Against Vaccine-matched NoV Genotypes
Up to 28 days post vaccination

Study Arms (15)

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.