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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01324440 | Safety, Tolerability, and Immunogenicity of a Single Dose of Merck 0657nI Staphylococcus Aureus Vaccine With or Without Merck Aluminum Adjuvant (V710-002) | PHASE1 | COMPLETED | 64 | — | — | Sep 1, 2006 | Oct 1, 2007 | Apr 10, 2015 | - | — |
| NCT00303069 | V710 First-In-Man (FIM) Study (V710-001) | PHASE1 | COMPLETED | 124 | — | — | Nov 1, 2005 | Jul 1, 2006 | Jul 22, 2015 | - | — |
Immunoglobulin G (IgG) antibodies were measured by a LUMINEX(TM) assay.
Immunoglobulin G (IgG) antibodies were measured by a LUMINEX(TM) assay.
Immunoglobulin G (IgG) antibodies were measured by a LUMINEX(TM) assay. The GMFR is the ratio of the antibody concentration at Day 14 to the antibody concentration at baseline.
Investigators were instructed to determine the seriousness and causality (relatedness to test vaccine) of each AE based on criteria defined in the protocol: A serious adverse event (SAE) is any AE that: * results in death, * is life threatening, * results in a persistent or significant disability/incapacity, * results in or prolongs an existing inpatient hospitalization, * is a congenital anomaly/birth defect, * is a cancer, * is an overdose, * or is another important medical event that may require medical or surgical intervention to prevent one of the outcomes listed above.
Participants with a serious vaccine-related adverse experiences (AE) (an AE which is assessed by an investigator/qualified physician as being related to study vaccine and results in death, persistent or significant disability/incapacity, prolongs an existing inpatient hospitalization, is life-threatening, a congenital anomaly/birth defect, a cancer, or an overdose).
| Arm | Type | Description |
|---|---|---|
| V710 without MAA | EXPERIMENTAL | - |
| V710 with MAA | ACTIVE_COMPARATOR | - |
| V710 5 μg | EXPERIMENTAL | V710 S. aureus vaccine |
| V710 30 μg | EXPERIMENTAL | V710 S. aureus vaccine |
| V710 90 μg | EXPERIMENTAL | V710 S. aureus vaccine |
| Placebo | PLACEBO_COMPARATOR | Placebo |
| Name | Type | Description |
|---|---|---|
| V710 (30 µg) with MAA | BIOLOGICAL | Single 0.5-mL injection (30-µg) of V710 with MAA, intramuscularly |
| V710 (30 µg) without MAA | BIOLOGICAL | Single 0.5-mL injection (30-µg) dose of V710 without MAA, intramuscularly |
| V710 | BIOLOGICAL | Single dose of V710 (at dosages of 5 μg, 30 μg, or 90 μg) intramuscularly |
| Comparator: Placebo | BIOLOGICAL | Single dose of saline placebo intramuscularly |
Inclusion criteria: * Participant was in good physical health * Participant was able to understand study procedures and agreed to participate in the study by providing written informed consent. * Participant was willing and able to participate in the entire study duration planned for up to 12 month...