Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
V920 Consistency Lot A · 1 trial · 1 indication
Serum was collected for determination of geometric mean titer (GMT) of anti-Zaire ebolavirus envelope (ZEBOV) glycoprotein antibodies using an enzyme-linked immunosorbent assay (GP-ELISA). The unit of measure is ELISA units/mL (EU/mL). The lower limit of quantification for the assay was 36.11 EU/mL.
An adverse event (AE) is defined as any untoward medical occurrence in a participant which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study vaccine or protocol-specified procedure, whether or not considered related to the study vaccine or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the study vaccine or protocol-specified procedure is also an adverse event. A serious AE (SAE) is an AE that results in death, is life threatening, results in persistent or significant disability or incapacity, results in or prolongs a hospitalization, is a congenital anomaly or birth defect, is any other important medical event, is a cancer, or is associated with an overdose.
An adverse event (AE) is defined as any untoward medical occurrence in a participant which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study vaccine or protocol-specified procedure, whether or not considered related to the study vaccine or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the study vaccine or protocol-specified procedure is also an adverse event. Injection-site AEs prompted on the Vaccination Report Card (VRC) were erythema, pain, and swelling.
Participants were instructed on the VRC to take and record their oral (or oral equivalent) temperature daily from the day of vaccination through Day 42. Elevated temperature was defined as ≥38.0° C (≥100.4° F).
An adverse event (AE) is defined as any untoward medical occurrence in a participant which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study vaccine or protocol-specified procedure, whether or not considered related to the study vaccine or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the study vaccine or protocol-specified procedure is also an adverse event. Adverse events of arthralgia and arthritis were prompted on the VRC.
An adverse event (AE) is defined as any untoward medical occurrence in a participant which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study vaccine or protocol-specified procedure, whether or not considered related to the study vaccine or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the study vaccine or protocol-specified procedure is also an adverse event. Rash AEs prompted on the VRC were petechial rash, purpuric rash, and vesicular-type rash.
An adverse event (AE) is defined as any untoward medical occurrence in a participant which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study vaccine or protocol-specified procedure, whether or not considered related to the study vaccine or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the study vaccine or protocol-specified procedure is also an adverse event. Vesicular lesion AEs prompted on the VRC included blister and rash vesicular.
| Arm | Type | Description |
|---|---|---|
| V920 Consistency Lot A | EXPERIMENTAL | Participants received a 1.0 mL intramuscular injection of V920 on Day 1 |
| V920 Consistency Lot B | EXPERIMENTAL | Participants received a 1.0 mL intramuscular injection of V920 on Day 1 |
| V920 Consistency Lot C | EXPERIMENTAL | Participants received a 1.0 mL intramuscular injection of V920 on Day 1 |
| V920 High-dose Lot | EXPERIMENTAL | Participants received a 1.0 mL intramuscular injection of V920 on Day 1 |
| Placebo to V920 | PLACEBO_COMPARATOR | Participants received a 1.0 mL intramuscular injection of placebo on Day 1 |
| Name | Type | Description |
|---|---|---|
| V920 Consistency Lot A | BIOLOGICAL | V920 (rVSV-ZEBOV-GP) Ebola Zaire vaccine consistency Lot A, live, attenuated, sterile solution for intramuscular injection |
| V920 Consistency Lot B | BIOLOGICAL | V920 (rVSV-ZEBOV-GP) Ebola Zaire vaccine consistency Lot B, live, attenuated, sterile solution for intramuscular injection |
| V920 Consistency Lot C | BIOLOGICAL | V920 (rVSV-ZEBOV-GP) Ebola Zaire vaccine consistency Lot C, live, attenuated, sterile solution for intramuscular injection |
| V920 High-dose Lot | BIOLOGICAL | V920 (rVSV-ZEBOV-GP) Ebola Zaire vaccine high-dose lot, live, attenuated, sterile solution for intramuscular injection |
| Placebo to V920 | BIOLOGICAL | Sodium chloride 0.9%, sterile solution for intramuscular injection |
Inclusion Criteria: * Not of reproductive potential, or of reproductive potential and agrees to avoid becoming pregnant or impregnating a partner for 2 months following study vaccination. Exclusion Criteria: * Is currently participating in or has participated in an interventional clinical trial w...
V920 Consistency Lot A is an investigational vaccine being studied for the prevention of Ebola infection. It is currently in Phase 3 clinical development and is not yet approved by regulatory authorities.
V920 Consistency Lot A is being developed by Merck & Company, Inc., a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol MRK.
V920 Consistency Lot A is in Phase 3 clinical development. It is an investigational vaccine and has not been approved for use. One Phase 3 trial has been completed.
V920 Consistency Lot A was studied in a completed Phase 3 trial with the identifier NCT02503202. This trial evaluated the safety and immunogenicity of three consistency lots and a high-dose lot of the V920 Ebola vaccine in healthy adults.
Yes, V920 Consistency Lot A is a version of the rVSV-ZEBOV-GP Ebola vaccine. The clinical trial NCT02503202 evaluated the safety and immunogenicity of three consistency lots and a high-dose lot of rVSV-ZEBOV-GP, which is also referred to as the V920 Ebola vaccine.