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VIR-2482 1200 mg did not demonstrate efficacy versus placebo in the primary analysis of the primary endpoint
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The purpose of this study is to evaluate the efficacy, safety, and tolerability of VIR-2482 compared to placebo in preventing influenza A illness in healthy adults 18 to <65 years of age without pre-existing risk factors for serious complications from influenza infection.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VIR-2482 (Dose 1) | Experimental |
| |
| VIR-2482 (Dose 2) | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VIR-2482 (450 mg) | Biological | VIR-2482 450mg given by intramuscular injection |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Protocol-defined Influenza-like Illness (ILI) With Confirmed Influenza A (by Reverse Transcription Polymerase Chain Reaction [RT-PCR]) | Protocol-defined ILI with confirmed influenza A defined as RT-PCR confirmed influenza A with at least one respiratory symptom and at least one systemic symptom | Up to 24 Weeks |
| Number of Participants With Adverse Events (AEs) | Up to 26 Weeks | |
| Number of Participants With Serious Adverse Events (SAEs) | Up to 26 Weeks | |
| Number of Participants With Adverse Events of Special Interest (AESI) | AESI is anaphylaxis per MedDRA anaphylaxis algorithmic SMQ | Up to 26 Weeks |
| Number of Participants With Vital Sign Abnormalities | Defined as a graded abnormality in systolic blood pressure, diastolic blood pressure, pulse, respiratory rate, or oral temperature as per the Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials at any time on/after receipt of study intervention. | Up to 26 Weeks |
| Number of Participants With Clinical Laboratory Abnormalities | Defined as graded abnormality in chemistry, hematology, liver function, or urinalysis clinical laboratory values as per the Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Trials at any time on/after receipt of study intervention. | Up to 26 Weeks |
| Number of Participants With Solicited Injection Site Reactions |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With CDC-defined Influenza-like Illness (ILI) With Confirmed Influenza A (by Reverse Transcription Polymerase Chain Reaction [RT-PCR]) | CDC-defined ILI with RT-PCR confirmed influenza A | Up to 24 Weeks |
| Percentage of Participants With WHO-defined Influenza-like Illness (ILI) With Confirmed Influenza A (by Reverse Transcription Polymerase Chain Reaction [RT-PCR]) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigative Site | Anniston | Alabama | 36207 | United States | ||
| Investigative Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39036981 | Derived | Tan SK, Cebrik D, Plotnik D, Agostini ML, Boundy K, Hebner CM, Yeh WW, Pang PS, Moya J, Fogarty C, Darani M, Hayden FG. A Randomized, Placebo-Controlled Trial to Evaluate the Safety and Efficacy of VIR-2482 in Healthy Adults for Prevention of Influenza A Illness (PENINSULA). Clin Infect Dis. 2024 Oct 15;79(4):1054-1061. doi: 10.1093/cid/ciae368. |
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| ID | Title | Description |
|---|---|---|
| FG000 | VIR-2482 (450 mg) | VIR-2482 (450 mg): VIR-2482 450 mg given by intramuscular injection |
| FG001 | VIR-2482 (1200 mg) | VIR-2482 (1200 mg): VIR-2482 1200 mg given by intramuscular injection |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 29, 2023 | May 3, 2024 |
Not provided
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| VIR-2482 (1200 mg) |
| Biological |
VIR-2482 1200 mg given by intramuscular injection |
|
| Placebo | Biological | Sterile 0.9% (w/v) sodium chloride solution given by intramuscular injection |
|
Injection site reactions from the study intervention diary card |
| Up to Day 7 following study intervention administration |
| Number of Participants With Solicited Systemic Reactions | Systemic reactions from the study intervention diary card | Up to Day 7 following study intervention administration |
WHO-defined ILI with RT-PCR confirmed influenza A |
| Up to 24 Weeks |
| Mobile |
| Alabama |
| 36608 |
| United States |
| Investigative Site | Tempe | Arizona | 85281 | United States |
| Investigative Site | Long Beach | California | 90805 | United States |
| Investigative Site | Pomona | California | 91767 | United States |
| Investigative Site | San Diego | California | 92123 | United States |
| Investigative Site | Aurora | Colorado | 80918 | United States |
| Investigative Site | Longmont | Colorado | 80501 | United States |
| Investigative Site | Fort Myers | Florida | 33912 | United States |
| Investigative Site | Jupiter | Florida | 33458 | United States |
| Investigative Site | Miami | Florida | 33144 | United States |
| Investigative Site | Miami | Florida | 33165 | United States |
| Investigative Site | Pembroke Pines | Florida | 33024 | United States |
| Investigative Site | Winter Park | Florida | 32789 | United States |
| Investigative Site | Lilburn | Georgia | 30047 | United States |
| Investigative Site | Meridian | Idaho | 83642 | United States |
| Investigative Site | Chicago | Illinois | 60625 | United States |
| Investigative Site | South Bend | Indiana | 46617 | United States |
| Investigative Site | El Dorado | Kansas | 67042 | United States |
| Investigative Site | Lenexa | Kansas | 66219 | United States |
| Investigative Site | Wichita | Kansas | 67205 | United States |
| Investigative Site | Lexington | Kentucky | 40509 | United States |
| Investigative Site | Versailles | Kentucky | 40383 | United States |
| Investigative Site | Metairie | Louisiana | 70006 | United States |
| Investigative Site | New Orleans | Louisiana | 70115 | United States |
| Investigative Site | Methuen | Massachusetts | 01844 | United States |
| Investigative Site | Kansas City | Missouri | 64114 | United States |
| Investigative Site | Las Vegas | Nevada | 89030 | United States |
| Investigative Site | Las Vegas | Nevada | 89102 | United States |
| Investigative Site | Rochester | New York | 14618 | United States |
| Investigative Site | Monroe | North Carolina | 28112 | United States |
| Investigative Site | Raleigh | North Carolina | 27612 | United States |
| Investigative Site | Cincinnati | Ohio | 45242 | United States |
| Investigative Site | Edmond | Oklahoma | 73013 | United States |
| Investigative Site | Yukon | Oklahoma | 73099 | United States |
| Investigative Site | Anderson | South Carolina | 29621 | United States |
| Investigative Site | North Charleston | South Carolina | 29405 | United States |
| Investigative Site | Spartanburg | South Carolina | 29303 | United States |
| Investigative Site | Rapid City | South Dakota | 57702 | United States |
| Investigative Site | Elizabethton | Tennessee | 37643 | United States |
| Investigative Site | Knoxville | Tennessee | 37909 | United States |
| Investigative Site | Austin | Texas | 78705 | United States |
| Investigative Site | Austin | Texas | 78745 | United States |
| Investigative Site | Cedar Park | Texas | 78613 | United States |
| Investigative Site | Dallas | Texas | 75251 | United States |
| Investigative Site | Houston | Texas | 77055 | United States |
| Investigative Site | San Angelo | Texas | 76904 | United States |
| Investigative Site | San Antonio | Texas | 78229 | United States |
| Investigative Site | Tomball | Texas | 77375 | United States |
| Investigative Site | Layton | Utah | 84041 | United States |
| Investigative Site | Norfolk | Virginia | 23502 | United States |
| FG002 | Placebo | Placebo: Sterile 0.9% (w/v) sodium chloride solution given by intramuscular injection |
| Received Study Intervention |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
All participants who received any amount of study intervention.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | VIR-2482 (450 mg) | VIR-2482 (450 mg): VIR-2482 450mg given by intramuscular injection |
| BG001 | VIR-2482 (1200 mg) | VIR-2482 (1200 mg): VIR-2482 1200 mg given by intramuscular injection |
| BG002 | Placebo | Placebo: Sterile 0.9% (w/v) sodium chloride solution given by intramuscular injection |
| BG003 | 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 |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||
| Body Mass Index | Body Mass Index at Screening | Mean | Standard Deviation | kg/m^2 |
|
| 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 | Percentage of Participants With Protocol-defined Influenza-like Illness (ILI) With Confirmed Influenza A (by Reverse Transcription Polymerase Chain Reaction [RT-PCR]) | Protocol-defined ILI with confirmed influenza A defined as RT-PCR confirmed influenza A with at least one respiratory symptom and at least one systemic symptom | Full Analysis Set (all randomized who did not have confirmed influenza infection within 3 months prior to randomization, did not receive an influenza vaccination for the upcoming influenza season, and received any amount of study intervention). Participants were analyzed according to the randomized study intervention. | Posted | Number | percentage of participants | Up to 24 Weeks |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Number of Participants With Adverse Events (AEs) | Participants who received any amount of study intervention. Participants were analyzed according to study intervention received. | Posted | Count of Participants | Participants | Up to 26 Weeks |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Number of Participants With Serious Adverse Events (SAEs) | Participants who received any amount of study intervention. Participants were analyzed according to the study intervention received. | Posted | Count of Participants | Participants | Up to 26 Weeks |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Number of Participants With Adverse Events of Special Interest (AESI) | AESI is anaphylaxis per MedDRA anaphylaxis algorithmic SMQ | Posted | Count of Participants | Participants | Up to 26 Weeks |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Number of Participants With Vital Sign Abnormalities | Defined as a graded abnormality in systolic blood pressure, diastolic blood pressure, pulse, respiratory rate, or oral temperature as per the Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials at any time on/after receipt of study intervention. | Participants who received any amount of study intervention and had a post-baseline vital sign measurement. Participants were analyzed according to the study intervention received. | Posted | Count of Participants | Participants | Up to 26 Weeks |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Number of Participants With Clinical Laboratory Abnormalities | Defined as graded abnormality in chemistry, hematology, liver function, or urinalysis clinical laboratory values as per the Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Trials at any time on/after receipt of study intervention. | Participants who received any amount of study intervention and had a post-baseline clinical laboratory assessment. Participants were analyzed according to the study intervention received. | Posted | Count of Participants | Participants | Up to 26 Weeks |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Number of Participants With Solicited Injection Site Reactions | Injection site reactions from the study intervention diary card | Participants who received any amount of study intervention . Participants were analyzed according to the study intervention received. | Posted | Count of Participants | Participants | Up to Day 7 following study intervention administration |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Number of Participants With Solicited Systemic Reactions | Systemic reactions from the study intervention diary card | Participants who received any amount of study intervention . Participants were analyzed according to the study intervention received. | Posted | Count of Participants | Participants | Up to Day 7 following study intervention administration |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With CDC-defined Influenza-like Illness (ILI) With Confirmed Influenza A (by Reverse Transcription Polymerase Chain Reaction [RT-PCR]) | CDC-defined ILI with RT-PCR confirmed influenza A | Full Analysis Set (all randomized who did not have confirmed influenza infection within 3 months prior to randomization, did not receive an influenza vaccination for the upcoming influenza season, and received any amount of study intervention). Participants were analyzed according to the randomized study intervention. | Posted | Number | percentage of participants | Up to 24 Weeks |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With WHO-defined Influenza-like Illness (ILI) With Confirmed Influenza A (by Reverse Transcription Polymerase Chain Reaction [RT-PCR]) | WHO-defined ILI with RT-PCR confirmed influenza A | Full Analysis Set (all randomized who did not have confirmed influenza infection within 3 months prior to randomization, did not receive an influenza vaccination for the upcoming influenza season, and received any amount of study intervention). Participants were analyzed according to the randomized study intervention. | Posted | Number | percentage of participants | Up to 24 Weeks |
|
|
through study completion for each participant, up to approximately 43 weeks
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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 | VIR-2482 (450 mg) | VIR-2482 (450 mg): VIR-2482 450mg given by intramuscular injection | 2 | 981 | 10 | 981 | 454 | 981 |
| EG001 | VIR-2482 (1200 mg) | VIR-2482 (1200 mg): VIR-2482 1200 mg given by intramuscular injection | 3 | 992 | 13 | 992 | 450 | 992 |
| EG002 | Placebo | Placebo: Sterile 0.9% (w/v) sodium chloride solution given by intramuscular injection | 0 | 983 | 9 | 983 | 460 | 983 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Appendicitis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Appendicitis perforated | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Pneumonia klebsiella | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Accidental overdose | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
| |
| Burns second degree | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
| |
| Injury | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
| |
| Intentional overdose | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
| |
| Splenic rupture | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
| |
| Traumatic fracture | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Arrhythmia | Cardiac disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Cardio-respiratory arrest | Cardiac disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Acute psychosis | Psychiatric disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Completed suicide | Psychiatric disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Conversion disorder | Psychiatric disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Major depression | Psychiatric disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Schizoaffective disorder bipolar type | Psychiatric disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Alcohol withdrawal syndrome | Psychiatric disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Enteritis | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Peptic ulcer haemorrhage | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Abdominal hernia | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Abortion spontaneous | Pregnancy, puerperium and perinatal conditions | MedDRA 26.0 | Systematic Assessment |
| |
| Vertigo positional | Ear and labyrinth disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Biliary dyskinesia | Hepatobiliary disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Cervical spinal stenosis | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Lumbar radiculopathy | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Uterine malposition | Reproductive system and breast disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Pelvic organ prolapse | Reproductive system and breast disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Orthostatic hypotension | Vascular disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Iron deficiency anaemia | Blood and lymphatic system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Drug withdrawal syndrome | General disorders | MedDRA 26.0 | Systematic Assessment | General disorders and administration site conditions |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Upper respiratory tract infection | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Inquiry | Vir Biotechnology, Inc. | 415-654-5281 | clinicaltrials@vir.bio |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 13, 2023 | May 3, 2024 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Relative risk reduction (RRR, %) | 3.78 | 2-Sided | 95 | -67.23 | 44.63 | RRR and 95% CI estimated using Poisson regression of multiple imputed data with treatment group the only factor in the model; 95% CI are nominal and not adjusted for multiple comparisons. | Superiority |
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| Participants |
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| Participants |
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| Participants |
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| Participants |
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