Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06655324 | A Study to Evaluate Safety, Tolerability, and Immunogenicity of V350A and V350B in Healthy Participants (V350-001). | PHASE1 | RECRUITING | 250 | — | — | Dec 5, 2024 | Jul 17, 2028 | Jun 1, 2026 | 9 | United States |
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. ...