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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06630117 | A Study of V330 in Healthy Younger (18 to 49 Years Inclusive) and Healthy Older (60 to 79 Years Inclusive) Participants (V330-001) | PHASE1 | COMPLETED | 245 | — | — | Mar 1, 2024 | Oct 17, 2025 | Nov 3, 2025 | 4 | United States |
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 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 assessed for local AEs related to axillary lymphadenopathy.
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 which include but are not limited to: 1) an elevated aspartate aminotransferase or alanine aminotransferase value greater than or equal to three times the upper limit of normal (ULN) and an elevated bilirubin value of greater than two times the ULN and, at the same time, an alkaline phosphatase value of less than two times the ULN, 2) an overdose of V330.
| Arm | Type | Description |
|---|---|---|
| Dose Escalation Panel A | EXPERIMENTAL | Participants 18 to 49 years old will be randomized to receive V330 dose level (DL) 1 or placebo via intramuscular injection on Day 1 and Day 57. |
| Dose Escalation Panel B | EXPERIMENTAL | Participants 18 to 49 years old will be randomized to receive V330 DL 3 or placebo via intramuscular injection on Day 1 and Day 57. |
| Dose Escalation Panel C | EXPERIMENTAL | Participants 18 to 49 years old will be randomized to receive V330 DL 6 or placebo via intramuscular injection on Day 1 and Day 57. |
| Dose Expansion Panel D | EXPERIMENTAL | Participants 18 to 49 years old will be randomized to receive a selected dose of V330 at less than or equal to DL 6 or placebo via intramuscular injection on Day 1. |
| Dose Expansion Panel E | EXPERIMENTAL | Participants 18 to 49 years old will be randomized to receive a selected dose of V330 at less than or equal to DL 6 or placebo via intramuscular injection on Day 1. |
| Dose Escalation Panel F | EXPERIMENTAL | Participants 60 to 79 years old will be randomized to receive V330 DL 1 or placebo via intramuscular injection on Day 1. |
| Dose Escalation Panel G | EXPERIMENTAL | Participants 60 to 79 years old will be randomized to receive V330 DL 3 or placebo via intramuscular injection on Day 1. |
| Dose Escalation Panel H | EXPERIMENTAL | Participants 60 to 79 years old will be randomized to receive V330 DL 6 or placebo via intramuscular injection on Day 1. |
| Dose Expansion Panel I | EXPERIMENTAL | Participants 60 to 79 years old will be randomized to receive a selected dose of V330 at less than or equal to DL 6 or placebo via intramuscular injection on Day 1. |
| Dose Expansion Panel J | EXPERIMENTAL | Participants 60 to 79 years old will be randomized to receive a selected dose of V330 at less than or equal to DL 6 or placebo via intramuscular injection on Day 1. |
| Dose Escalation Panel A1 | EXPERIMENTAL | Participants 18 to 49 years old will be randomized to receive V330 DL 2 or placebo via intramuscular injection on Day 1. |
| Dose Escalation Panel B1 | EXPERIMENTAL | Participants 18 to 49 years old will be randomized to receive V330 DL 5 or placebo via intramuscular injection on Day 1. |
| Dose Escalation Panel F1 | EXPERIMENTAL | Participants 60 to 79 years old will be randomized to receive V330 DL 2 or placebo via intramuscular injection on Day 1. |
| Dose Escalation Panel G1 | EXPERIMENTAL | Participants 60 to 79 years old will be randomized to receive V330 DL 5 or placebo via intramuscular injection on Day 1. |
| Dose Escalation Panel H1 | EXPERIMENTAL | Participants 60 to 79 years old will be randomized to receive V330 DL 4 or placebo via intramuscular injection on Day 1. |
| Name | Type | Description |
|---|---|---|
| V330 | BIOLOGICAL | Intramuscular injection |
| Placebo | BIOLOGICAL | Intramuscular injection |
Inclusion Criteria: The key inclusion criteria include but are not limited to the following: * Is in good health prior to randomization * Is an individual from 18 to 49 years of age inclusive or from 60 to 79 years of age inclusive Exclusion Criteria: The key exclusion criteria include but are n...