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| ID | Type | Description | Link |
|---|---|---|---|
| U10HL074424 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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Pneumococcal disease is a serious bacterial infection that can affect different parts of the body, including the lungs. People with chronic illnesses, such as chronic obstructive pulmonary disease (COPD), have a greater risk of developing pneumonia and meningitis as a result of pneumococcal disease. This study will compare the immune response to two types of pneumococcal vaccines in adults with COPD.
Individuals who are infected with the Streptococcus pneumoniae bacteria may develop pneumococcal disease, a serious disease that kills more people in the United States than all other vaccine-preventable diseases combined. Individuals with COPD, characterized by breathing difficulties due to damaged and obstructed lung airways, may have an increased risk of developing serious complications from pneumococcal disease, including pneumonia and meningitis. Currently, there are two types of pneumococcal vaccines available. The pneumococcal capsular polysaccharide (CPS) vaccine, known as Pneumovax, is typically given to adults 65 years of age or older and to any individuals with a serious health condition, including heart disease, lung disease, and diabetes. The diphtheria protein-conjugated vaccine (PCV7), known as Prevnar, is typically given to infants; however, adults who receive this vaccine may also have a favorable response. The purpose of this study is to compare the immune response to the Pneumovax and Prevnar vaccines in adults with COPD.
This study will enroll adults with mild to moderate COPD. Participants will be randomly assigned to receive either the Pneumovax or Prevnar vaccine. This will involve one or two injections. Blood collection will occur during study visits at Months 1, 12, and 24. Study researchers will contact participants by telephone at Months 6 and 18 to document any pneumococcal infections and any additional pneumococcal vaccinations.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pneumovax (PPSV23) | Active Comparator | pneumococcal capsular polysaccharide vaccine (PPSV23) (Pneumovax) |
|
| Prevnar (PCV7) | Active Comparator | diphtheria protein-conjugated vaccine (PCV7) (Prevnar) 1.0 mL dose |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pneumovax (PPSV23) | Biological | Injection |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Serotype Opsonization Titers | Opsonophagocytosis activity (OPK) serotype specific geometric means | Measured at Baseline, Months 1, 12, and 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Serotype-specific Immunoglobulin G (IgG) Antibody Levels | Serotype-specific immunoglobulin G Geometric Mean IgG antibody levels (ug/ml) | Measured at Baseline, Months 1, 12, and 24 |
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Inclusion Criteria:
Diagnosis of Chronic Obstructive Pulmonary Disease (COPD)
Post-bronchodilator forced expiratory volume at one second
/forced vital capacity (FEV1/FVC) level less than 70%
Ten or more pack-years of smoking
Willing to make return visits to the study clinic and accept telephone contact
Last pneumococcal vaccination occured at least 5 years prior to study entry
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Antonello Punturieri, MD | National Heart, Lung, and Blood Institute (NHLBI) | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35249 | United States | ||
| Veteran's Administration Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22652582 | Derived | Dransfield MT, Harnden S, Burton RL, Albert RK, Bailey WC, Casaburi R, Connett J, Cooper JA, Criner GJ, Curtis JL, Han MK, Make B, Marchetti N, Martinez FJ, McEvoy C, Nahm MH, Niewoehner DE, Porszasz J, Reilly J, Scanlon PD, Scharf SM, Sciurba FC, Washko GR, Woodruff PG, Lazarus SC; NIH COPD Clinical Research Network. Long-term comparative immunogenicity of protein conjugate and free polysaccharide pneumococcal vaccines in chronic obstructive pulmonary disease. Clin Infect Dis. 2012 Sep;55(5):e35-44. doi: 10.1093/cid/cis513. Epub 2012 May 31. | |
| 19556517 |
| Label | URL |
|---|---|
| Click here for the National Institutes of Health Web site. | View source |
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Participant's were recruited from 10 medical centers across the US from April 9, 2007 to May 7, 2009.
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| ID | Title | Description |
|---|---|---|
| FG000 | Pneumovax (PPSV23) | pneumococcal capsular polysaccharide vaccine (PPSV23) (Pneumovax) |
| FG001 | Prevnar (PCV7) | diphtheria protein-conjugated vaccine (PCV7) (Prevnar) 1.0 mL dose |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Prevnar (PCV7) | Biological | Injection |
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| Birmingham |
| Alabama |
| 35294-0006 |
| United States |
| LA BioMed at Harbor, University of California | Los Angeles | California | 90502 | United States |
| University of California San Francisco-Airway Clinical Research Center | San Francisco | California | 94143 | United States |
| Denver Health Medical Center | Denver | Colorado | 80204-4507 | United States |
| National Jewish Medical and Research Center | Denver | Colorado | 80204-4507 | United States |
| Veteran's Administration Medical Center | Denver | Colorado | 80220 | United States |
| University of Maryland Hospital | Baltimore | Maryland | 21201 | United States |
| Fallon Clinic | Boston | Massachusetts | 02115 | United States |
| Brigham and Women's Hospital | Boston | Massachusetts | 02132 | United States |
| Veteran's Administration Medical Center | Boston | Massachusetts | 02132 | United States |
| Veteran's Administration Medical Center | Ann Arbor | Michigan | 48105 | United States |
| University of Michigan Medical Center | Ann Arbor | Michigan | 48109-0360 | United States |
| Veteran's Administration Medical Center | Minneapolis | Minnesota | 55417 | United States |
| HealthPartners Research Foundation | Minneapolis | Minnesota | 55440 | United States |
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
| Temple University Lung Center | Philadelphia | Pennsylvania | 19140 | United States |
| University of Pittsburgh Emphysema Research Center | Pittsburgh | Pennsylvania | 15213 | United States |
| Derived |
| Dransfield MT, Nahm MH, Han MK, Harnden S, Criner GJ, Martinez FJ, Scanlon PD, Woodruff PG, Washko GR, Connett JE, Anthonisen NR, Bailey WC; COPD Clinical Research Network. Superior immune response to protein-conjugate versus free pneumococcal polysaccharide vaccine in chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2009 Sep 15;180(6):499-505. doi: 10.1164/rccm.200903-0488OC. Epub 2009 Jun 25. |
| 1-Month |
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| 1-Year |
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| 2-Year |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Pneumovax (PPSV23) | pneumococcal capsular polysaccharide vaccine (PPSV23) (Pneumovax) |
| BG001 | Prevnar (PCV7) | diphtheria protein-conjugated vaccine (PCV7) (Prevnar) 1.0 mL dose |
| BG002 | 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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| Region of Enrollment | Number | participants |
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| Forced expiratory volume at one second (FEV1) | Mean | Standard Deviation | LIters (L) |
| |||||||||||||||
| FEV1 (% Predicted) | Mean | Standard Deviation | percent predicted |
| |||||||||||||||
| forced expiratory volume at one second/forced vital capacity (FEV1/FVC) | Mean | Standard Deviation | percentage of FEV1/FVC |
| |||||||||||||||
| Race | Number | participants |
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| Oxygen use at baseline | Number | participants |
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| Pack years smoking | Mean | Standard Deviation | pack years |
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| Current Smoker | Number | participants |
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| Vaccine Naive | Number | 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 | Serotype Opsonization Titers | Opsonophagocytosis activity (OPK) serotype specific geometric means | All participants with blood samples were analyzed. | Posted | Geometric Mean | 95% Confidence Interval | titers | Measured at Baseline, Months 1, 12, and 24 |
|
|
| |||||||||||||||||||||||||||||||||||
| Secondary | Serotype-specific Immunoglobulin G (IgG) Antibody Levels | Serotype-specific immunoglobulin G Geometric Mean IgG antibody levels (ug/ml) | All participants with blood samples were analyzed. | Posted | Geometric Mean | 95% Confidence Interval | ug/ml | Measured at Baseline, Months 1, 12, and 24 |
|
|
2 Years
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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 | Pneumovax (PPSV23) | pneumococcal capsular polysaccharide vaccine (PPSV23) (Pneumovax) | 27 | 90 | 58 | 90 | ||
| EG001 | Prevnar (PCV7) | diphtheria protein-conjugated vaccine (PCV7) (Prevnar) 1.0 mL dose | 32 | 91 | 54 | 91 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Intestinal Infectious Disease | Infections and infestations | Systematic Assessment |
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| Tuberculosis | Infections and infestations | Systematic Assessment |
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| Viral Infection | Infections and infestations | Systematic Assessment |
| ||
| Oral Neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| Digestive Neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| Respiratory Neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| Benign or Uncertain Neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| Adrenal Insufficiency | Endocrine disorders | Systematic Assessment |
| ||
| Hypercalcemia | Endocrine disorders | Systematic Assessment |
| ||
| Anemia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Cataract | Eye disorders | Systematic Assessment |
| ||
| Hypertensive | Vascular disorders | Systematic Assessment |
| ||
| Ischemic Heart Disease | Cardiac disorders | Systematic Assessment |
| ||
| Pulmonary Circulation | Vascular disorders | Systematic Assessment |
| ||
| Other Heart Disease | Cardiac disorders | Systematic Assessment |
| ||
| Atherosclerosis | Vascular disorders | Systematic Assessment |
| ||
| Pneumonia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Influenza | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| COPD | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Enteritis | Gastrointestinal disorders | Systematic Assessment |
| ||
| Intestinal Obstruction | Gastrointestinal disorders | Systematic Assessment |
| ||
| Liver Disease | Gastrointestinal disorders | Systematic Assessment |
| ||
| Inflammatory diseases of prostate | Renal and urinary disorders | Systematic Assessment |
| ||
| Cystitis | Renal and urinary disorders | Systematic Assessment |
| ||
| Menorrhagia | Reproductive system and breast disorders | Systematic Assessment |
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| Skin Infection | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Arthropy | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Osteopathy | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Epistaxis | General disorders | Systematic Assessment |
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| Other Respiratory | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Death Unkown Cause | General disorders | Systematic Assessment |
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| Complication from surgery | Injury, poisoning and procedural complications | Systematic Assessment |
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| Fracture | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Concussion | Injury, poisoning and procedural complications | Systematic Assessment |
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| Multiple drug intoxication | Injury, poisoning and procedural complications | Systematic Assessment |
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| Brain Neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| Neuroendocrine Neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| Cerebrovascular Disease | Nervous system disorders | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Benign or Uncertain Neoplasms | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| Acute Respiratory Infection | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Skin - Inflammatory | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Arthropathy | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Pain | Nervous system disorders | Systematic Assessment |
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| COPD | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Rheumatism | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Other - Respiratory | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Sprains | Investigations | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sarah Harnden | University of Minnesota | 612-626-9011 | sharnden@ccbr.umn.edu |
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D022242 | Pneumococcal Vaccines |
| C414006 | 23-valent pneumococcal capsular polysaccharide vaccine |
| D000069443 | Heptavalent Pneumococcal Conjugate Vaccine |
| ID | Term |
|---|---|
| D022541 | Streptococcal Vaccines |
| D001428 | Bacterial Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D017778 | Vaccines, Combined |
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| Male |
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| African American |
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| Asian |
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| Native American |
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| Pacific Islander |
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| More than one |
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| Non-oxygen user |
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| Non-Current Smoker |
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| Previously Vaccinated |
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| Serotype 4 1-Year |
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| Serotype 4 2-Year |
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| Serotype 6B Baseline |
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| Serotype 6B 1-Month |
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| Serotype 6B 1-Year |
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| Serotype 6B 2-Year |
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| Serotype 9V Baseline |
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| Serotype 9V 1-Month |
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| Serotype 9V 1-Year |
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| Serotype 9V 2-Year |
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| Serotype 14 Baseline |
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| Serotype 14 1-Month |
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| Serotype 14 1-Year |
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| Serotype 14 2-Year |
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| Serotype 18C Baseline |
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| Serotype 18C 1-Month |
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| Serotype 18C 1-Year |
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| Serotype 18C 2-Year |
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| Serotype 19F Baseline |
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| Serotype 19F 1-Month |
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| Serotype 19F 1-year |
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| Serotype 19F 2-Year |
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| Serotype 23F Baseline |
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| Serotype 23F 1-Month |
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| Serotype 23F 1-Year |
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| Serotype 23F 2-Year |
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|