Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
V710 · 3 trials · 2 indications
Geometric mean fold rise is calculated as the natural logarithm of the ratio of Day 14 and baseline antibody titers.
Vaccine-related adverse experiences are those determined by the investigator to be possibly, probably, or definitely vaccine-related.
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 | EXPERIMENTAL | V710 vaccination (60 mcg) single dose on Day 1 |
| Placebo | PLACEBO_COMPARATOR | Placebo single dose on Day 1 |
| 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 |
| Name | Type | Description |
|---|---|---|
| V710 | BIOLOGICAL | V710 vaccination (60 mcg, 0.5 ml) single injection on Day 1 |
| Placebo | BIOLOGICAL | Saline placebo (0.5 ml) single injection on Day 1 |
| 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 |
| Comparator: Placebo | BIOLOGICAL | Single dose of saline placebo intramuscularly |
Inclusion Criteria: * Generally Good Physical Health Exclusion Criteria: * Received V710 Vaccine, Any Other Investigational S. Aureus Vaccine, Or Investigational S. Aureus Antibodies Before * Temperature Of Equal/Greater Than 100.4 Degrees F(38 Degrees C) Within The Past 48 Hours
V710 is an investigational vaccine being studied for the prevention of Staphylococcus infections, including Staphylococcus aureus. It is being evaluated in healthy volunteers and in individuals at risk for staphylococcal infections. The drug is currently in Phase 1 clinical development and is not yet approved by regulatory authorities.
V710 is being developed by Merck & Company, Inc., which is publicly traded under the ticker symbol MRK. The company is conducting clinical trials to evaluate the safety and immunogenicity of this investigational vaccine for staphylococcal infections.
V710 is in Phase 1 clinical development. All completed trials for this drug are Phase 1 studies, and there are no active trials currently ongoing. The drug remains investigational and has not received regulatory approval for any indication.
V710 has been studied in several completed Phase 1 trials, including NCT00303069, NCT00735839, NCT00822757, and NCT01324440. These trials evaluated the vaccine in healthy volunteers and in individuals with staphylococcal infections, with total enrollment of 188 participants across all studies.
V710 is classified as a monoclonal antibody modality, but it is being studied as a vaccine for staphylococcal infections. The drug is designed to elicit an immune response against Staphylococcus bacteria, and it is being evaluated for safety and immunogenicity in clinical trials.
V710 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development. The completed trials have focused on safety and immunogenicity, but the drug has not yet received marketing authorization from the FDA or any other regulatory agency.