HealthyPhase 1NCT06630117
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 study testing V330 in people with Healthy, run by Merck Sharp & Dohme LLC at 4 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 79 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- V330
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 245 participants
- Where
- 4 sitesUnited States
- Study dates
- 1 Mar 2024to 17 Oct 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 79 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country.
United States4 sites
California Clinical Trials Medical Group managed by PAREXEL ( Site 0002)
Glendale, California, 91206
Velocity Clinical Research, Hallandale Beach ( Site 0003)
Hallandale, Florida, 33009
Research Centers of America ( Hollywood ) ( Site 0004)
Hollywood, Florida, 33024
QPS-MRA, LLC-Early Phase ( Site 0006)
South Miami, Florida, 33143
About this study
Official 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).
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.
- Conditions
- Healthy
- Being tested
- V330, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
V330Biological
Intramuscular injection
PlaceboBiological
Intramuscular injection
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Biological: V330; Biological: Placebo |
| 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. Receives: Biological: V330; Biological: Placebo |
| 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. Receives: Biological: V330; Biological: Placebo |
| 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. Receives: Biological: V330; Biological: Placebo |
| 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. Receives: Biological: V330; Biological: Placebo |
| 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. Receives: Biological: V330; Biological: Placebo |
| 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. Receives: Biological: V330; Biological: Placebo |
| 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. Receives: Biological: V330; Biological: Placebo |
| 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. Receives: Biological: V330; Biological: Placebo |
| 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. Receives: Biological: V330; Biological: Placebo |
| 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. Receives: Biological: V330; Biological: Placebo |
| 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. Receives: Biological: V330; Biological: Placebo |
| 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. Receives: Biological: V330; Biological: Placebo |
| 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. Receives: Biological: V330; Biological: Placebo |
| 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. Receives: Biological: V330; Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
The GMT of virus like particle (VLP) serum antibody titers measured by HBGA blocking assay will be determined.
Measured: Up to 28 days post vaccination
GMT of IgG Antibodies Response Against Vaccine-matched NoV Genotypes
The GMT of VLP serum antibody titers measured by IgG immunoassay will be determined.
Measured: Up to 28 days post vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2024
- Study start1 Mar 2024
- Primary completion17 Oct 2025
- Study completion17 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 245 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06630117
- Sponsor's protocol ID
- V330-001
- Status last verified
- Oct 2025
- First submitted
- 3 Oct 2024
- Last updated
- 3 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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).
- ClinicalTrials.gov ID
- NCT06630117
- Acronym / sponsor ID
- V330-001
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 245 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 17 Oct 2025 (actual)
- Study completion
- 17 Oct 2025 (actual)
- First posted
- 8 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 15
| Arm | Type | Receives |
|---|---|---|
| Dose Escalation Panel A | Experimental | Biological: V330, Biological: PlaceboParticipants 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 | Biological: V330, Biological: PlaceboParticipants 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 | Biological: V330, Biological: PlaceboParticipants 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 | Biological: V330, Biological: PlaceboParticipants 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 | Biological: V330, Biological: PlaceboParticipants 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 | Experimental | Biological: V330, Biological: PlaceboParticipants 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 | Biological: V330, Biological: PlaceboParticipants 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 | Biological: V330, Biological: PlaceboParticipants 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 | Biological: V330, Biological: PlaceboParticipants 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 | Biological: V330, Biological: PlaceboParticipants 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 | Biological: V330, Biological: PlaceboParticipants 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 | Biological: V330, Biological: PlaceboParticipants 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 | Biological: V330, Biological: PlaceboParticipants 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 | Biological: V330, Biological: PlaceboParticipants 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 | Biological: V330, Biological: PlaceboParticipants 60 to 79 years old will be randomized to receive V330 DL 4 or placebo via intramuscular injection on Day 1. |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- Has a history of myocarditis, pericarditis, and/or myopericarditis
- Has a history of cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| V330Intramuscular injection | Biological | Dose Escalation Panel A, Dose Escalation Panel A1, Dose Escalation Panel B, Dose Escalation Panel B1, Dose Escalation Panel C, Dose Escalation Panel F, Dose Escalation Panel F1, Dose Escalation Panel G, Dose Escalation Panel G1, Dose Escalation Panel H, Dose Escalation Panel H1, Dose Expansion Panel D, Dose Expansion Panel E, Dose Expansion Panel I, Dose Expansion Panel J |
| PlaceboIntramuscular injection | Biological | Dose Escalation Panel A, Dose Escalation Panel A1, Dose Escalation Panel B, Dose Escalation Panel B1, Dose Escalation Panel C, Dose Escalation Panel F, Dose Escalation Panel F1, Dose Escalation Panel G, Dose Escalation Panel G1, Dose Escalation Panel H, Dose Escalation Panel H1, Dose Expansion Panel D, Dose Expansion Panel E, Dose Expansion Panel I, Dose Expansion Panel J |
Primary outcome
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).
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.
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.
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.
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.
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.
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.
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.
2 secondary outcomes
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
GMT of IgG Antibodies Response Against Vaccine-matched NoV Genotypes
Time frame: Up to 28 days post vaccination
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2025.
- Merck Clinical Trials InformationLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Merck Sharp & Dohme LLC
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing V330 in people with Healthy, run by Merck Sharp & Dohme LLC at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Solicited Injection Site Adverse Events (AEs) (time frame: Up to approximately 7 days after each vaccination). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2025.