Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
V118E · 1 trial · 1 indication
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, which occurs during the course of the study. A solicited AE is a predefined event that participants are specifically asked about and record on their vaccine report card (VRC). Solicited injection-site AEs include redness, swelling, and pain or tenderness. The number of participants with a solicited injection-site AE will be reported.
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, which occurs during the course of the study. A solicited AE is a predefined event that participants are specifically asked about and record on their VRC. Solicited systemic AEs include fever, muscle aches all over body, joint pain, headache, and tiredness. The number of participants with a solicited systemic AE will be reported.
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, which occurs during the course of the study. The number of participants with immediate AEs following vaccination will be reported.
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, which occurs during the course of the study. An unsolicited AE is an event that is not solicited using a VRC and that is communicated by a participant. The number of participants who experience an unsolicited AE will be reported.
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.
A MAAE is defined as an adverse event 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. The number of participants who experience a MAAE will be reported.
AESIs are selected serious and nonserious AEs which include but are not limited to: 1) Potential drug-induced liver injury (DILI) events defined as an elevated aspartate aminotransferase (AST) or alanine aminotransferase (ALT) laboratory value that is ≥3\* the upper limit of normal (ULN) and an elevated total bilirubin laboratory value that is ≥2\* the ULN and, at the same time, an alkaline phosphatase laboratory value that is \<2\* the ULN, as determined by way of protocol-specified laboratory testing or unscheduled laboratory testing. 2) an overdose of V118E. 3) Potential immune-mediated disease (pIMDs) defined as a subset of AEs that an established autoimmune disease(s) AND inflammatory and/or neurologic disorder(s), which might or might not have an autoimmune etiology. The number of participants who experience an AESI will be reported.
| Arm | Type | Description |
|---|---|---|
| V118E | EXPERIMENTAL | Participants receive intramuscular (IM) injection of V118E in a 2-dose regimen administered on Day 1 and Day 29. |
| 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. |
| Name | Type | Description |
|---|---|---|
| V118E | BIOLOGICAL | IM administration |
| PREVNAR 20™ | BIOLOGICAL | IM administration |
| Saline | BIOLOGICAL | IM administration |
Inclusion Criteria: The main inclusion criteria include but are not limited to the following: \- Is in good health before randomization Exclusion Criteria: The main exclusion criteria include but are not limited to the following: * Has a history of invasive pneumococcal disease or known history...
V118E is an investigational monoclonal antibody being developed by Merck & Company, Inc. (MRK). It is currently in Phase 1 clinical development for use in healthy participants. The drug is being studied in a single active-controlled, double-blind, randomized trial in the United States.
V118E is being studied for use in healthy participants. It is currently in Phase 1 clinical development, meaning it is being evaluated for safety and tolerability in a clinical trial setting. The drug is not yet approved for any medical condition.
V118E is being developed by Merck & Company, Inc., a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol MRK. The company is conducting a Phase 1 clinical trial of V118E in healthy participants in the United States.
V118E is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. The drug is currently being studied in a Phase 1 trial that is recruiting participants in the United States.
V118E is being studied in a Phase 1 clinical trial with the identifier NCT07168915, titled "A Study of V118E in Healthy Participants (V118E-003)". The trial is recruiting 126 healthy participants in the United States and is active, with a randomized, double-blind, active-controlled design.