HealthyPhase 1NCT06611033
A Study of V118 Formulation C (V118C) in Healthy Participants (V118C-001)
A Phase 1 study testing V118C, V118 and PREVNAR 20™ in people with Healthy, run by Merck Sharp & Dohme LLC at 3 sites in United States.
Trial summary
The goal of this study is to learn how safe V118 Formulation C is in Healthy Adults and how well people tolerate it. Read more about this study
- Who is it for?
- Ages 18 to 49 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- V118C, V118 and PREVNAR 20™
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 3 sitesUnited States
- Study dates
- 25 Sep 2024to 9 Jan 2026
- 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 49 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
None listed.
Who cannot join
- Has a history of invasive pneumococcal disease or known history of other culture-positive pneumococcal disease within 3 years prior to receiving study vaccination.
- Has a history of clinically significant endocrine, GI, cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological (including stroke and chronic seizures) abnormalities or diseases.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University of Texas Medical Branch ( Site 0001)
Galveston, Texas, 77555-1115
Velocity Clinical Research, Hallandale Beach ( Site 0003)
Hallandale, Florida, 33009
Research Centers of America ( Hollywood ) ( Site 0002)
Hollywood, Florida, 33024
About this study
Official title: A Randomized, Double-Blind Study to Evaluate the Safety, Tolerability, and Immunogenicity of V118 Formulation C in Healthy Adults
The goal of this study is to learn how safe V118 Formulation C is in Healthy Adults and how well people tolerate it.
- Conditions
- Healthy
- Being tested
- V118C, V118, PREVNAR 20™, Saline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
V118CBiological
Intramuscular Administration
V118Biological
Intramuscular Administration
PREVNAR 20™Biological
Intramuscular Administration
SalineBiological
Intramuscular Administration
| Study group | Role | What they receive |
|---|---|---|
| V118C | Experimental | Participants receive intramuscular (IM) injection of V118C in a 2-dose regimen administered on Day 1 and Day 29. Receives: Biological: V118C |
| V118 | Experimental | Participants receive IM injection of V118 in a 2-dose regimen administered on Day 1 and Day 29. Receives: Biological: V118; Biological: Saline |
| PREVNAR 20™ + Saline | Active comparator | Participants receive one dose of IM injection of PREVNAR 20™ in a 2-dose regimen on Day 1 followed by one dose of saline on Day 29. Receives: Biological: PREVNAR 20™; Biological: Saline |
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 defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The number of participants with a solicited injection-site AE will be reported.
Measured: Up to approximately 7 days after each vaccination
Number of Participants with Solicited Systemic AEs
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The number of participants with a solicited systemic AE will be reported.
Measured: Up to approximately 7 days after each vaccination
Number of Participants with Immediate AEs Following Vaccination
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The number of participants with Immediate AEs following vaccination will be reported.
Measured: Up to approximately 30 minutes after each vaccination
Number of Participants with Unsolicited AEs
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. An unsolicited AE is an AE that is not solicited using a vaccine report card (VRC) and that is communicated by a participant. The number of participants that experienced an unsolicited AE will be reported.
Measured: Up to approximately 28 days after each vaccination
Number of Participants With a Serious Adverse Event (SAE)
An SAE is defined as any untoward medical occurrence that at any dose, results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect. The number of participants who experience an SAE will be reported.
Measured: Up to approximately 12 months after final vaccination
Number of Participants with a Medically Attended Adverse Event (MAAE)
An MAAE is defined as an adverse event in which medical attention is received during an unscheduled, non-routine outpatient visit, such as an emergency room visit, office visit, or an urgent care visit with any medical personnel for any reason. The number of participants who experience an MAAE will be reported.
Measured: Up to approximately 12 months after final vaccination
Number of Participants with an Event of Clinical Interest (ECI)
An ECI includes but is not limited to: 1) An overdose defined as: A participant receiving more than 1 dose of study vaccine in a 24-hour period or more than 2 doses of study vaccine throughout the study. 2) Potential drug-induced liver injury (DILI) events defined as: An elevated aspartate aminotransferase (AST) or alanine aminotransferase (ALT) lab value that is ≥3 times the upper limit of normal (ULN) and an elevated total bilirubin lab value that is ≥2 times ULN and, at the same time, an alkaline phosphatase lab value that is <2 times ULN, as determined by way of protocol-specified laboratory testing or unscheduled laboratory testing. 3) Potential immune-mediated disease (pIMDs) defined as: A subset of AEs that include either an established autoimmune disease(s) or Inflammatory and/or neurologic disorder(s), which might or might not have an autoimmune etiology. The number of participants who experience an ECI will be reported.
Measured: Up to approximately 12 months after final vaccination
Secondary outcomes (1)
Serotype-specific Immunoglobulin G (IgG) geometric mean concentrations (GMCs)
The GMCs for serotype-specific IgG antibodies will be determined using pneumococcal electrochemiluminescence (Pn ECL) assay.
Measured: Day 28 postvaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2024
- Study start25 Sep 2024
- Primary completion9 Jan 2026
- Study completion9 Jan 2026
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
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 65 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
- NCT06611033
- Sponsor's protocol ID
- V118C-001
- Status last verified
- Jan 2026
- First submitted
- 20 Sep 2024
- Last updated
- 20 Jan 2026
- 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 20 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind Study to Evaluate the Safety, Tolerability, and Immunogenicity of V118 Formulation C in Healthy Adults
- ClinicalTrials.gov ID
- NCT06611033
- Acronym / sponsor ID
- V118C-001
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- 25 Sep 2024 (actual)
- Primary completion
- 9 Jan 2026 (actual)
- Study completion
- 9 Jan 2026 (actual)
- First posted
- 24 Sep 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 how safe V118 Formulation C is in Healthy Adults and how well people tolerate it.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| V118C | Experimental | Biological: V118CParticipants receive intramuscular (IM) injection of V118C in a 2-dose regimen administered on Day 1 and Day 29. |
| V118 | Experimental | Biological: V118, Biological: SalineParticipants receive IM injection of V118 in a 2-dose regimen administered on Day 1 and Day 29. |
| PREVNAR 20™ + Saline | Active comparator | Biological: PREVNAR 20™, Biological: SalineParticipants receive one dose of IM injection of PREVNAR 20™ in a 2-dose regimen on Day 1 followed by one dose of saline on Day 29. |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (0 listed)
Key exclusion criteria (2 listed)
- Has a history of invasive pneumococcal disease or known history of other culture-positive pneumococcal disease within 3 years prior to receiving study vaccination.
- Has a history of clinically significant endocrine, GI, cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological (including stroke and chronic seizures) abnormalities or diseases.
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 |
|---|---|---|
| V118CIntramuscular Administration | Biological | V118C |
| V118Intramuscular Administration | Biological | V118 |
| PREVNAR 20™Intramuscular Administration | Biological | PREVNAR 20™ + Saline |
| SalineIntramuscular Administration | Biological | PREVNAR 20™ + Saline, V118 |
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 defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The number of participants with a solicited injection-site AE will be reported.
Number of Participants with Solicited Systemic AEs
Time frame: Up to approximately 7 days after each vaccination
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The number of participants with a solicited systemic AE will be reported.
Number of Participants with Immediate AEs Following Vaccination
Time frame: Up to approximately 30 minutes after each vaccination
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The number of participants with Immediate AEs following vaccination will be reported.
Number of Participants with Unsolicited AEs
Time frame: Up to approximately 28 days after each vaccination
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. An unsolicited AE is an AE that is not solicited using a vaccine report card (VRC) and that is communicated by a participant. The number of participants that experienced an unsolicited AE will be reported.
Number of Participants With a Serious Adverse Event (SAE)
Time frame: Up to approximately 12 months after final vaccination
An SAE is defined as any untoward medical occurrence that at any dose, results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect. The number of participants who experience an SAE will be reported.
Number of Participants with a Medically Attended Adverse Event (MAAE)
Time frame: Up to approximately 12 months after final vaccination
An MAAE is defined as an adverse event in which medical attention is received during an unscheduled, non-routine outpatient visit, such as an emergency room visit, office visit, or an urgent care visit with any medical personnel for any reason. The number of participants who experience an MAAE will be reported.
Number of Participants with an Event of Clinical Interest (ECI)
Time frame: Up to approximately 12 months after final vaccination
An ECI includes but is not limited to: 1) An overdose defined as: A participant receiving more than 1 dose of study vaccine in a 24-hour period or more than 2 doses of study vaccine throughout the study. 2) Potential drug-induced liver injury (DILI) events defined as: An elevated aspartate aminotransferase (AST) or alanine aminotransferase (ALT) lab value that is ≥3 times the upper limit of normal (ULN) and an elevated total bilirubin lab value that is ≥2 times ULN and, at the same time, an alkaline phosphatase lab value that is <2 times ULN, as determined by way of protocol-specified laboratory testing or unscheduled laboratory testing. 3) Potential immune-mediated disease (pIMDs) defined as: A subset of AEs that include either an established autoimmune disease(s) or Inflammatory and/or neurologic disorder(s), which might or might not have an autoimmune etiology. The number of participants who experience an ECI will be reported.
1 secondary outcome
Serotype-specific Immunoglobulin G (IgG) geometric mean concentrations (GMCs)
Time frame: Day 28 postvaccination
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 20 Jan 2026.
- 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
3 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 V118C, V118 and PREVNAR 20™ in people with Healthy, run by Merck Sharp & Dohme LLC at 3 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 0 inclusion and 2 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 20 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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 7 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 20 Jan 2026.