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Completed

NCT Number: NCT06630117

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

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.

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Key information

Conditions

Healthy

Age range

18 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

California Clinical Trials Medical Group managed by PAREXEL ( Site 0002), Glendale, California, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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 exclusion criteria include but are not limited to the following:

  • Has a history of myocarditis, pericarditis, and/or myopericarditis
  • Has a history of cancer

Treatment and study plan

V330

Biological

Intramuscular injection

Placebo

Biological

Intramuscular injection

Primary outcomes

  1. Number of Participants with Solicited Injection Site Adverse Events (AEs)

    Time frame: 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).

  2. Number of Participants with Solicited Systemic AEs

    Time frame: 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.

  3. Number of Participants with Solicited Local AEs of Axillary Lymphadenopathy

    Time frame: 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.

  4. Number of Participants with Immediate AEs Following Vaccinations

    Time frame: 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.

  5. Number of Participants with Unsolicited AEs

    Time frame: 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.

  6. Number of Participants with Serious AEs

    Time frame: 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.

  7. Number of Participants with Medically Attended Adverse Events (MAAEs)

    Time frame: 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.

  8. Number of Participants with Events of Clinical Interest (ECIs)

    Time frame: 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 outcomes

  1. Geometric Mean Titers (GMT) of Histo-Blood Group Antigen (HBGA) Blocking Antibodies Against Vaccine-matched Norovirus (NoV) Genotypes

    Time frame: Up to 28 days post vaccination

    The GMT of virus like particle (VLP) serum antibody titers measured by HBGA blocking assay will be determined.

  2. GMT of IgG Antibodies Response Against Vaccine-matched NoV Genotypes

    Time frame: Up to 28 days post vaccination

    The GMT of VLP serum antibody titers measured by IgG immunoassay will be determined.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

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).

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Oct 8, 2024
Registry last updated
Nov 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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