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

NCT ID: NCT06630117

Last Updated: 2025-11-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

245 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-01

Study Completion Date

2025-10-17

Brief Summary

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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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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Dose Escalation Panel A

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.

Group Type EXPERIMENTAL

V330

Intervention Type BIOLOGICAL

Intramuscular injection

Placebo

Intervention Type BIOLOGICAL

Intramuscular injection

Dose Escalation Panel B

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.

Group Type EXPERIMENTAL

V330

Intervention Type BIOLOGICAL

Intramuscular injection

Placebo

Intervention Type BIOLOGICAL

Intramuscular injection

Dose Escalation Panel C

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.

Group Type EXPERIMENTAL

V330

Intervention Type BIOLOGICAL

Intramuscular injection

Placebo

Intervention Type BIOLOGICAL

Intramuscular injection

Dose Expansion Panel D

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.

Group Type EXPERIMENTAL

V330

Intervention Type BIOLOGICAL

Intramuscular injection

Placebo

Intervention Type BIOLOGICAL

Intramuscular injection

Dose Expansion Panel E

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.

Group Type EXPERIMENTAL

V330

Intervention Type BIOLOGICAL

Intramuscular injection

Placebo

Intervention Type BIOLOGICAL

Intramuscular injection

Dose Escalation Panel F

Participants 60 to 79 years old will be randomized to receive V330 DL 1 or placebo via intramuscular injection on Day 1.

Group Type EXPERIMENTAL

V330

Intervention Type BIOLOGICAL

Intramuscular injection

Placebo

Intervention Type BIOLOGICAL

Intramuscular injection

Dose Escalation Panel G

Participants 60 to 79 years old will be randomized to receive V330 DL 3 or placebo via intramuscular injection on Day 1.

Group Type EXPERIMENTAL

V330

Intervention Type BIOLOGICAL

Intramuscular injection

Placebo

Intervention Type BIOLOGICAL

Intramuscular injection

Dose Escalation Panel H

Participants 60 to 79 years old will be randomized to receive V330 DL 6 or placebo via intramuscular injection on Day 1.

Group Type EXPERIMENTAL

V330

Intervention Type BIOLOGICAL

Intramuscular injection

Placebo

Intervention Type BIOLOGICAL

Intramuscular injection

Dose Expansion Panel I

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.

Group Type EXPERIMENTAL

V330

Intervention Type BIOLOGICAL

Intramuscular injection

Placebo

Intervention Type BIOLOGICAL

Intramuscular injection

Dose Expansion Panel J

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.

Group Type EXPERIMENTAL

V330

Intervention Type BIOLOGICAL

Intramuscular injection

Placebo

Intervention Type BIOLOGICAL

Intramuscular injection

Dose Escalation Panel A1

Participants 18 to 49 years old will be randomized to receive V330 DL 2 or placebo via intramuscular injection on Day 1.

Group Type EXPERIMENTAL

V330

Intervention Type BIOLOGICAL

Intramuscular injection

Placebo

Intervention Type BIOLOGICAL

Intramuscular injection

Dose Escalation Panel B1

Participants 18 to 49 years old will be randomized to receive V330 DL 5 or placebo via intramuscular injection on Day 1.

Group Type EXPERIMENTAL

V330

Intervention Type BIOLOGICAL

Intramuscular injection

Placebo

Intervention Type BIOLOGICAL

Intramuscular injection

Dose Escalation Panel F1

Participants 60 to 79 years old will be randomized to receive V330 DL 2 or placebo via intramuscular injection on Day 1.

Group Type EXPERIMENTAL

V330

Intervention Type BIOLOGICAL

Intramuscular injection

Placebo

Intervention Type BIOLOGICAL

Intramuscular injection

Dose Escalation Panel G1

Participants 60 to 79 years old will be randomized to receive V330 DL 5 or placebo via intramuscular injection on Day 1.

Group Type EXPERIMENTAL

V330

Intervention Type BIOLOGICAL

Intramuscular injection

Placebo

Intervention Type BIOLOGICAL

Intramuscular injection

Dose Escalation Panel H1

Participants 60 to 79 years old will be randomized to receive V330 DL 4 or placebo via intramuscular injection on Day 1.

Group Type EXPERIMENTAL

V330

Intervention Type BIOLOGICAL

Intramuscular injection

Placebo

Intervention Type BIOLOGICAL

Intramuscular injection

Interventions

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V330

Intramuscular injection

Intervention Type BIOLOGICAL

Placebo

Intramuscular injection

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* 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

* Has a history of myocarditis, pericarditis, and/or myopericarditis
* Has a history of cancer
Minimum Eligible Age

18 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Locations

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California Clinical Trials Medical Group managed by PAREXEL ( Site 0002)

Glendale, California, United States

Site Status

Velocity Clinical Research, Hallandale Beach ( Site 0003)

Hallandale, Florida, United States

Site Status

Research Centers of America ( Hollywood ) ( Site 0004)

Hollywood, Florida, United States

Site Status

QPS-MRA, LLC-Early Phase ( Site 0006)

South Miami, Florida, United States

Site Status

Countries

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United States

Related Links

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https://www.merckclinicaltrials.com

Merck Clinical Trials Information

Other Identifiers

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V330-001

Identifier Type: -

Identifier Source: org_study_id

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