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V350A · 1 trial · 1 indication
An adverse event (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).
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.
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.
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.
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.
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.
ECIs are selected serious and nonserious AEs are defined as an overdose of Sponsor's product, drug-induced liver injury events, or potential immune-mediated diseases (pIMDs).
| Arm | Type | Description |
|---|---|---|
| V350A | EXPERIMENTAL | Participants will receive V350A vaccinations on Day 1, Month 2, and Month 6. |
| V350B | EXPERIMENTAL | Participants will receive V350B vaccinations on Day 1, Month 2, and Month 6. |
| Placebo | PLACEBO_COMPARATOR | Participants will receive placebo vaccinations on Day 1, Month 2, and Month 6. |
| Name | Type | Description |
|---|---|---|
| V350A | BIOLOGICAL | Vaccination administered via intramuscular injection |
| V350B | BIOLOGICAL | Vaccination administered via intramuscular injection |
| Placebo | BIOLOGICAL | Vaccination administered via intramuscular injection |
Inclusion Criteria: The key inclusion criteria include but are not limited to the following: * Is in good health before randomization. * Has a body mass index between 18 and 38 kg/m\^2, inclusive, for adults 18-30; has a body mass index between 15 and 38 kg/m\^2, inclusive, for adolescents 12-17. ...
V350A 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 to evaluate its safety, tolerability, and immunogenicity.
V350A is a monoclonal antibody, but its specific molecular target has not been disclosed. The drug is being studied in healthy participants to assess its safety, tolerability, and immunogenicity, as part of early-stage clinical development.
V350A is being developed by Merck & Company, Inc., which trades under the ticker symbol MRK. The company is conducting a Phase 1 clinical trial to evaluate the drug's safety, tolerability, and immunogenicity in healthy participants.
V350A is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. A Phase 1 trial is currently recruiting participants to evaluate the drug's safety, tolerability, and immunogenicity.
V350A is being studied in a Phase 1 clinical trial with the identifier NCT06655324. The trial, titled 'A Study to Evaluate Safety, Tolerability, and Immunogenicity of V350A and V350B in Healthy Participants (V350-001),' is recruiting 250 participants in the United States. The study is randomized, double-blind, and placebo-controlled.
V350A and V350B are being studied together in the same clinical trial, NCT06655324, which evaluates the safety, tolerability, and immunogenicity of both drugs in healthy participants. However, they are distinct investigational agents being developed by Merck & Company, Inc.