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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-001658-14 | EudraCT Number | ||
| V920-012 | Other Identifier | Merck Protocol Number |
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The study evaluated the safety and immunogenicity of 3 consistency lots and a high-dose lot of rVSV-ZEBOV-GP (V920 Ebola Vaccine) in healthy adults. The primary purpose of this study was to demonstrate consistency in the immune responses of participants receiving 3 separate lots of V920 through 28 days postvaccination. In addition to the 3 lot groups, a high-dose group and a placebo group were studied. A subset of participants representative of all treatment groups continued through 24 months postvaccination in the extension study for the evaluation of long-term safety. The primary hypothesis states that the geometric mean titer of anti-Zaire ebolavirus envelope (ZEBOV) glycoprotein antibody at 28 days postvaccination is equivalent across the three consistency lots.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 | Arm Group Labels | Other Names |
|---|---|---|---|---|
| V920 Consistency Lot A | Biological | V920 (rVSV-ZEBOV-GP) Ebola Zaire vaccine consistency Lot A, live, attenuated, sterile solution for intramuscular injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Geometric Mean Titer of Anti-ZEBOV Glycoprotein Antibody | 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. | Day 28 postvaccination |
| Percentage of Participants Reporting Serious Adverse Events | 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. | Up to Month 6 postvaccination |
| Percentage of Participants With Injection-site Adverse Events Prompted on the Vaccination Report Card | 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. | Up to Day 5 postvaccination |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28549145 | Result | Halperin SA, Arribas JR, Rupp R, Andrews CP, Chu L, Das R, Simon JK, Onorato MT, Liu K, Martin J, Helmond FA; V920-012 Study Team. Six-Month Safety Data of Recombinant Vesicular Stomatitis Virus-Zaire Ebola Virus Envelope Glycoprotein Vaccine in a Phase 3 Double-Blind, Placebo-Controlled Randomized Study in Healthy Adults. J Infect Dis. 2017 Jun 15;215(12):1789-1798. doi: 10.1093/infdis/jix189. | |
| 33782211 |
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A total of 1261 participants were screened and 1197 were randomized.
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| ID | Title | Description |
|---|---|---|
| FG000 | V920 Consistency Lot A | Participants received a 1.0-mL intramuscular injection of V920 consistency Lot A on Day 1 |
| FG001 | V920 Consistency Lot B | Participants received a 1.0-mL intramuscular injection of V920 consistency Lot B on Day 1 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Base Study: Up to Month 6 |
|
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| 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 |
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| 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 |
|
| Percentage of Participants With Elevated Maximum Temperature | 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). | Up to Day 42 postvaccination |
| Percentage of Participants With Arthralgia or Arthritis Adverse Events Prompted on the Vaccination Report Card | 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. | From Day 5 to Day 42 postvaccination |
| Percentage of Participants With Rash Adverse Events Prompted on the Vaccination Report Card | 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. | Up to Day 42 postvaccination |
| Percentage of Participants With Vesicular Lesion Adverse Events Prompted on the Vaccination Report Card | 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. | Up to Day 42 postvaccination |
| Derived |
| Grant-Klein RJ, Antonello J, Nichols R, Dubey S, Simon JK. Effects of Gamma Irradiation of Human Serum Samples from rVSVDeltaG-ZEBOV-GP (V920) Ebola Virus Vaccine Recipients on Plaque-Reduction Neutralization Assays. Am J Trop Med Hyg. 2021 Mar 29;104(5):1751-1754. doi: 10.4269/ajtmh.20-1055. |
| 31505665 | Derived | Halperin SA, Das R, Onorato MT, Liu K, Martin J, Grant-Klein RJ, Nichols R, Coller BA, Helmond FA, Simon JK; V920-012 Study Team. Immunogenicity, Lot Consistency, and Extended Safety of rVSVDeltaG-ZEBOV-GP Vaccine: A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study in Healthy Adults. J Infect Dis. 2019 Aug 30;220(7):1127-1135. doi: 10.1093/infdis/jiz241. |
| 28647166 | Derived | Coller BG, Blue J, Das R, Dubey S, Finelli L, Gupta S, Helmond F, Grant-Klein RJ, Liu K, Simon J, Troth S, VanRheenen S, Waterbury J, Wivel A, Wolf J, Heppner DG, Kemp T, Nichols R, Monath TP. Clinical development of a recombinant Ebola vaccine in the midst of an unprecedented epidemic. Vaccine. 2017 Aug 16;35(35 Pt A):4465-4469. doi: 10.1016/j.vaccine.2017.05.097. Epub 2017 Jun 21. |
| FG002 | V920 Consistency Lot C | Participants received a 1.0-mL intramuscular injection of V920 consistency Lot C on Day 1 |
| FG003 | V920 High-dose Lot | Participants received a 1.0-mL intramuscular injection of V920 high-dose lot on Day 1 |
| FG004 | Placebo | Participants received a 1.0-mL intramuscular injection of placebo on Day 1 |
| Vaccinated |
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| COMPLETED |
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| NOT COMPLETED |
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| Extension: Month 6 to 24 |
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All randomized participants
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| ID | Title | Description |
|---|---|---|
| BG000 | V920 Consistency Lot A | Participants received a 1.0-mL intramuscular injection of V920 consistency Lot A on Day 1 |
| BG001 | V920 Consistency Lot B | Participants received a 1.0-mL intramuscular injection of V920 consistency Lot B on Day 1 |
| BG002 | V920 Consistency Lot C | Participants received a 1.0-mL intramuscular injection of V920 consistency Lot C on Day 1 |
| BG003 | V920 High-dose Lot | Participants received a 1.0-mL intramuscular injection of V920 high-dose lot on Day 1 |
| BG004 | Placebo | Participants received a 1.0-mL intramuscular injection of placebo on Day 1 |
| BG005 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Geometric Mean Titer of Anti-ZEBOV Glycoprotein Antibody | 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. | Participants who were compliant with the protocol, received vaccination, were seronegative at Day 1, and had a serum sample collected within the acceptable day range | Posted | Geometric Mean | 95% Confidence Interval | EU/mL | Day 28 postvaccination |
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| Primary | Percentage of Participants Reporting Serious Adverse Events | 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. | Randomized participants who received vaccination and had follow-up data for the outcome measure | Posted | Number | Percentage of participants | Up to Month 6 postvaccination |
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| Primary | Percentage of Participants With Injection-site Adverse Events Prompted on the Vaccination Report Card | 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. | Randomized participants who received vaccination and had follow-up data for the outcome measure | Posted | Number | Percentage of participants | Up to Day 5 postvaccination |
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| Primary | Percentage of Participants With Elevated Maximum Temperature | 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). | Randomized participants who received vaccination and had follow-up data for the outcome measure | Posted | Number | Percentage of participants | Up to Day 42 postvaccination |
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| Primary | Percentage of Participants With Arthralgia or Arthritis Adverse Events Prompted on the Vaccination Report Card | 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. | Randomized participants who received vaccination and had follow-up data for the outcome measure | Posted | Number | Percentage of participants | From Day 5 to Day 42 postvaccination |
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| Primary | Percentage of Participants With Rash Adverse Events Prompted on the Vaccination Report Card | 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. | Randomized participants who received vaccination and had follow-up data for the outcome measure | Posted | Number | Percentage of participants | Up to Day 42 postvaccination |
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| Primary | Percentage of Participants With Vesicular Lesion Adverse Events Prompted on the Vaccination Report Card | 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. | Randomized participants who received vaccination and had follow-up data for the outcome measure | Posted | Number | Percentage of participants | Up to Day 42 postvaccination |
|
Up to Month 24
The at-risk population was randomized participants who received vaccination and had follow-up safety data available.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | V920 Consistency Lot A | Participants received a 1.0-mL intramuscular injection of V920 consistency Lot A on Day 1 | 2 | 265 | 12 | 265 | 211 | 265 |
| EG001 | V920 Consistency Lot B | Participants received a 1.0-mL intramuscular injection of V920 consistency Lot B on Day 1 | 1 | 263 | 12 | 263 | 211 | 263 |
| EG002 | V920 Consistency Lot C | Participants received a 1.0-mL intramuscular injection of V920 consistency Lot C on Day 1 | 0 | 263 | 11 | 263 | 208 | 263 |
| EG003 | V920 High-dose Lot | Participants received a 1.0-mL intramuscular injection of V920 high-dose lot on Day 1 | 0 | 260 | 8 | 260 | 208 | 260 |
| EG004 | Placebo | Participants received a 1.0-mL intramuscular injection of placebo on Day 1 | 0 | 133 | 4 | 133 | 35 | 133 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Conductive deafness | Ear and labyrinth disorders | MedDRA version 20.1 | Systematic Assessment |
| |
| Autoimmune thyroiditis | Endocrine disorders | MedDRA version 20.1 | Systematic Assessment |
| |
| Hyperthyroidism | Endocrine disorders | MedDRA version 20.1 | Systematic Assessment |
| |
| Abdominal incarcerated hernia | Gastrointestinal disorders | MedDRA version 20.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA version 20.1 | Systematic Assessment |
| |
| Gastrointestinal disorder | Gastrointestinal disorders | MedDRA version 20.1 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA version 20.1 | Systematic Assessment |
| |
| Incarcerated umbilical hernia | Gastrointestinal disorders | MedDRA version 20.1 | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA version 20.1 | Systematic Assessment |
| |
| Hepatic failure | Hepatobiliary disorders | MedDRA version 20.1 | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA version 20.1 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA version 20.1 | Systematic Assessment |
| |
| Clostridium difficile infection | Infections and infestations | MedDRA version 20.1 | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA version 20.1 | Systematic Assessment |
| |
| Mastitis | Infections and infestations | MedDRA version 20.1 | Systematic Assessment |
| |
| Meningitis aseptic | Infections and infestations | MedDRA version 20.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA version 20.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA version 20.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA version 20.1 | Systematic Assessment |
| |
| Animal bite | Injury, poisoning and procedural complications | MedDRA version 20.1 | Systematic Assessment |
| |
| Arthropod bite | Injury, poisoning and procedural complications | MedDRA version 20.1 | Systematic Assessment |
| |
| Craniocerebral injury | Injury, poisoning and procedural complications | MedDRA version 20.1 | Systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA version 20.1 | Systematic Assessment |
| |
| Rib fracture | Injury, poisoning and procedural complications | MedDRA version 20.1 | Systematic Assessment |
| |
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA version 20.1 | Systematic Assessment |
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| Scapula fracture | Injury, poisoning and procedural complications | MedDRA version 20.1 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA version 20.1 | Systematic Assessment |
| |
| Hyperglycaemic hyperosmolar nonketotic syndrome | Metabolism and nutrition disorders | MedDRA version 20.1 | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA version 20.1 | Systematic Assessment |
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| Exostosis | Musculoskeletal and connective tissue disorders | MedDRA version 20.1 | Systematic Assessment |
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| Foot deformity | Musculoskeletal and connective tissue disorders | MedDRA version 20.1 | Systematic Assessment |
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| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA version 20.1 | Systematic Assessment |
| |
| Spinal column stenosis | Musculoskeletal and connective tissue disorders | MedDRA version 20.1 | Systematic Assessment |
| |
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 20.1 | Systematic Assessment |
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| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 20.1 | Systematic Assessment |
| |
| Breast cancer stage III | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 20.1 | Systematic Assessment |
| |
| Oropharyngeal squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 20.1 | Systematic Assessment |
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| Migraine | Nervous system disorders | MedDRA version 20.1 | Systematic Assessment |
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| Radicular pain | Nervous system disorders | MedDRA version 20.1 | Systematic Assessment |
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| Abortion spontaneous | Pregnancy, puerperium and perinatal conditions | MedDRA version 20.1 | Systematic Assessment |
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| Ruptured ectopic pregnancy | Pregnancy, puerperium and perinatal conditions | MedDRA version 20.1 | Systematic Assessment |
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| Schizophrenia | Psychiatric disorders | MedDRA version 20.1 | Systematic Assessment |
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| Suicidal ideation | Psychiatric disorders | MedDRA version 20.1 | Systematic Assessment |
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| Nephrolithiasis | Renal and urinary disorders | MedDRA version 20.1 | Systematic Assessment |
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| Renal failure | Renal and urinary disorders | MedDRA version 20.1 | Systematic Assessment |
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| Menometrorrhagia | Reproductive system and breast disorders | MedDRA version 20.1 | Systematic Assessment |
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| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA version 20.1 | Systematic Assessment |
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| Haemothorax | Respiratory, thoracic and mediastinal disorders | MedDRA version 20.1 | Systematic Assessment |
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| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA version 20.1 | Systematic Assessment |
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| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA version 20.1 | Systematic Assessment |
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| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA version 20.1 | Systematic Assessment |
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| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA version 20.1 | Systematic Assessment |
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| Angioedema | Skin and subcutaneous tissue disorders | MedDRA version 20.1 | Systematic Assessment |
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| Deep vein thrombosis | Vascular disorders | MedDRA version 20.1 | Systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA version 20.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA version 20.1 | Systematic Assessment |
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| Chills | General disorders | MedDRA version 20.1 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA version 20.1 | Systematic Assessment |
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| Influenza like illness | General disorders | MedDRA version 20.1 | Systematic Assessment |
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| Injection site erythema | General disorders | MedDRA version 20.1 | Systematic Assessment |
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| Injection site pain | General disorders | MedDRA version 20.1 | Systematic Assessment |
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| Injection site swelling | General disorders | MedDRA version 20.1 | Systematic Assessment |
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| Pain | General disorders | MedDRA version 20.1 | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA version 20.1 | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA version 20.1 | Systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA version 20.1 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA version 20.1 | Systematic Assessment |
|
The Sponsor must have the opportunity to review all proposed abstracts, manuscripts or presentations regarding this trial 45 days prior to submission for publication/presentation. Any information identified by the Sponsor as confidential must be deleted prior to submission; this confidentiality does not include efficacy and safety results. Sponsor review can be expedited to meet publication timelines.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp. | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
| Death |
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| Lost to Follow-up |
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| Physician Decision |
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| Withdrawal by Subject |
|
| Male |
|
| ANOVA | <0.001 | Primary analysis: a p-value <0.025 supported the conclusion of equivalence. If equivalence was established for the 3 pairwise comparisons, the lots would be considered to be consistent. | GMT ratio (Lot A / Lot C) | 0.88 | 2-Sided | 95 | 0.71 | 1.09 | Equivalence | Lot consistency requires the 95% confidence interval of the GMT ratio of >0.5 and ≤2.0 for the primary analysis and >0.67 and ≤1.5 for the secondary analysis. |
| ANOVA | <0.001 | Primary analysis: a p-value <0.025 supported the conclusion of equivalence. If equivalence was established for the 3 pairwise comparisons, the lots would be considered to be consistent. | GMT ratio (Lot B / Lot C) | 0.94 | 2-Sided | 95 | 0.77 | 1.15 | Equivalence | Lot consistency requires the 95% confidence interval of the GMT ratio of >0.5 and ≤2.0 for the primary analysis and >0.67 and ≤1.5 for the secondary analysis. |
| OG002 |
| V920 Consistency Lot C |
Participants received a 1.0-mL intramuscular injection of V920 consistency Lot C on Day 1 |
| OG003 | V920 High-dose Lot | Participants received a 1.0-mL intramuscular injection of V920 high-dose lot on Day 1 |
| OG004 | Placebo | Participants received a 1.0-mL intramuscular injection of placebo on Day 1 |
|
|
|
Participants received a 1.0-mL intramuscular injection of V920 consistency Lot C on Day 1
| OG003 | V920 High-dose Lot | Participants received a 1.0-mL intramuscular injection of V920 high-dose lot on Day 1 |
| OG004 | Placebo | Participants received a 1.0-mL intramuscular injection of placebo on Day 1 |
|
|
|
| OG004 | Placebo | Participants received a 1.0-mL intramuscular injection of placebo on Day 1 |
|
|
|
Participants received a 1.0-mL intramuscular injection of V920 consistency Lot C on Day 1
| OG003 | V920 High-dose Lot | Participants received a 1.0-mL intramuscular injection of V920 high-dose lot on Day 1 |
| OG004 | Placebo | Participants received a 1.0-mL intramuscular injection of placebo on Day 1 |
|
|
|
Participants received a 1.0-mL intramuscular injection of V920 consistency Lot C on Day 1
| OG003 | V920 High-dose Lot | Participants received a 1.0-mL intramuscular injection of V920 high-dose lot on Day 1 |
| OG004 | Placebo | Participants received a 1.0-mL intramuscular injection of placebo on Day 1 |
|
|
|
Participants received a 1.0-mL intramuscular injection of V920 consistency Lot C on Day 1
| OG003 | V920 High-dose Lot | Participants received a 1.0-mL intramuscular injection of V920 high-dose lot on Day 1 |
| OG004 | Placebo | Participants received a 1.0-mL intramuscular injection of placebo on Day 1 |
|
|
|