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Also known as V132 Formulation 1, V132 Formulation 2, V132 Formulation 3
V132 · 1 trial · 1 indication
An adverse event (AE) is any untoward medical occurrence in a 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 immediate reactions occurring within 30 minutes after any vaccination will be reported.
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. The solicited injection-site AEs assessed are redness/erythema, swelling, and tenderness/pain. The percentage of participants with a solicited injection-site adverse event 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 treatment, whether or not considered related to the study treatment. The solicited systemic AEs assessed are muscle pain/myalgia, joint pain/arthralgia, headache, and tiredness/fatigue. The percentage of participants with a solicited systemic adverse event will be reported.
An unsolicited AE is an AE that was not solicited using a vaccination report card (VRC) 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 at least 1 unsolicited adverse event will be reported.
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. The percentage of participants that experienced 1 or more SAEs will be reported.
A medically attended adverse event (MAAE) is an AE 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 percentage of participants with at least 1 MAAE will be reported.
Events of clinical interest (ECIs) are defined as an overdose of Sponsor's product, drug-induced liver injury events, or potential immune-mediated diseases (pIMDs). The percentage of participants who experienced an adverse event of clinical interest will be reported.
| Arm | Type | Description |
|---|---|---|
| Part 1: Dose Escalation | EXPERIMENTAL | Participants will receive single intramuscular (IM) doses of a V132 formulation or comparator regimen at varying dose levels. |
| Part 2: Dose Expansion | EXPERIMENTAL | Participants will receive single IM doses of a V132 formulation or comparator regimen. Doses will be determined based on review of Part 1 data and will not exceed maximum dose level assessed in Part 1. |
| Name | Type | Description |
|---|---|---|
| V132 Formulation 1 | BIOLOGICAL | Experimental |
| V132 Formulation 2 | BIOLOGICAL | Experimental |
| V132 Formulation 3 | BIOLOGICAL | Experimental |
| PREVNAR 20™ | BIOLOGICAL | Active Comparator |
| CAPVAXIVE™ | BIOLOGICAL | Active Comparator |
Inclusion Criteria: The key inclusion criteria include but are not limited to the following: * Is in good health * Has body mass index (BMI) within 18.0 to 35.0 kg/m\^2 (inclusive) Exclusion Criteria: The key exclusion criteria include but are not limited to the following: * Has a history of in...
V132 is an investigational monoclonal antibody being developed by Merck & Company, Inc. It is in Phase 1 clinical development and is being studied in healthy older participants. The specific disease indications V132 is intended to treat have not been disclosed.
V132 is being developed by Merck & Company, Inc., which trades under the ticker MRK. Merck is the sponsor of the Phase 1 study of V132 in healthy older participants.
V132 is in Phase 1 clinical development. It is investigational and has not been approved by the FDA. One Phase 1 trial of V132 is currently recruiting, and no trials of V132 have been completed.
V132 is being studied in one clinical trial, NCT07712575, titled A Study of V132 in Healthy Older Participants (V132-001). The trial is a recruiting Phase 1 study in the United States with an enrollment of 280 participants aged 50 years and older.
Yes. V132 Formulation 1, V132 Formulation 2, and V132 Formulation 3 are alternative names for V132, the investigational monoclonal antibody developed by Merck & Company, Inc. These names refer to the same drug asset.
The V132 Phase 1 trial, NCT07712575, is a randomized, double-blind, controlled study enrolling 280 healthy participants aged 50 years and older in the United States. It is currently recruiting and is not biomarker selected.