Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
V175 · 1 trial · 1 indication
The percentage of participants with immediate reactions after vaccination will be reported.
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. The percentage of participants with a solicited injection-site AE (ie, pre-listed in the participant's diary) will be reported.
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The percentage of participants with a solicited systemic AE (ie, pre-listed in the participant's diary) will be reported.
An unsolicited AE is an AE that was not solicited using a vaccination report card and that is communicated by a participant (or their legally acceptable representative, if applicable). Unsolicited AEs include serious and nonserious AEs. The percentage of participants with an unsolicited adverse event 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 percentage of participants with a SAE will be reported.
MAAEs are defined as adverse events 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 percentage of participants with a MAAE will be reported.
AESIs are selected serious and nonserious AEs which include but are not limited to pIMDs defined as a subset of AEs that includes both: established autoimmune disease(s) and inflammatory and/or neurologic disorder(s), which might or might not have an autoimmune etiology. The percentage of participants with an AESI will be reported.
| Arm | Type | Description |
|---|---|---|
| V175 | EXPERIMENTAL | Participants will receive a single intramuscular (IM) vaccination of V175 on Day 1. |
| V175A | EXPERIMENTAL | Participants will receive a single IM vaccination of V175A on Day 1. |
| Control Vaccine | ACTIVE_COMPARATOR | Participants will receive a single IM vaccination of control vaccine on Day 1. |
| Placebo | PLACEBO_COMPARATOR | Participants will receive a single IM vaccination of placebo on Day 1. |
| Name | Type | Description |
|---|---|---|
| V175 | BIOLOGICAL | Intramuscular administration |
| V175A | BIOLOGICAL | Intramuscular administration |
| Control Vaccine | BIOLOGICAL | Intramuscular administration |
| Placebo | OTHER | Intramuscular administration |
Inclusion Criteria: The main inclusion criteria include but are not limited to the following: * Is in good health * Is an individual of any sex/gender, from 18 years to 49 years of age inclusive, or 60 years to 84 years of age inclusive * Has a body mass index between 18 and 35 kg/m\^2, inclusive ...
V175 is an investigational monoclonal antibody being developed by Merck & Company, Inc. (ticker MRK) for lower respiratory tract infection. It is in Phase 1 clinical development and has not been approved. The program includes one registered trial, which is not yet recruiting.
V175 is being studied for lower respiratory tract infection. The only registered trial of V175 enrolls healthy adult volunteers rather than patients with active infection, so the current work is early-stage and focused on the healthy volunteer setting. No approved use has been established for V175.
V175 is developed by Merck & Company, Inc., which trades under the ticker MRK. Merck is the sponsor of the single registered Phase 1 trial of V175, listed as NCT07855510, titled A Clinical Trial of V175 and V175A in Healthy Adults.
V175 is in Phase 1 clinical development. It is investigational and has not been approved. The program has one registered trial, which is currently not yet recruiting, and no completed trials. The trial is a randomized, double-blind, placebo-controlled Phase 1 study.
V175 is being studied in one registered trial, NCT07855510, titled A Clinical Trial of V175 and V175A in Healthy Adults. It is a Phase 1, randomized, double-blind, placebo-controlled study in lower respiratory tract infection, with a planned enrollment of 564 participants aged 18 years and older.
Yes. The Phase 1 trial of V175, NCT07855510, is conducted in healthy adults aged 18 years and older of all sexes. It is a randomized, double-blind, placebo-controlled study with a planned enrollment of 564 participants and is listed as not yet recruiting.