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| Name | Class |
|---|---|
| Department of Health and Human Services | FED |
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Evaluate Safety, Tolerability and Immune response of adjuvanted H5N1 cell culture derived influenza vaccine in elderly subjects
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| aH5N1c - High dose | Experimental |
| |
| aH5N1c - Low dose | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adjuvanted H5N1 pandemic influenza vaccine | Biological | Comparison of two doses of aH5N1c vaccine |
|
| Measure | Description | Time Frame |
|---|---|---|
| The Percentages Of Subjects Achieving Hemagglutination Inhibition (HI) Titers ≥40 Against A/H5N1 Strain. | The optimal aH5N1c vaccine formulation was evaluated in terms of percentages of subjects achieving HI titers ≥40 against homologous A/H5N1 strain, three weeks after second vaccination with either low dose or high dose of aH5N1c vaccine, according to the Center for Biologics Evaluation and Research (CBER) criterion. The CBER criterion for the elderly population is met if the lower limit of the two-sided 95% confidence interval (CI) for the percentages of subjects achieving HI titer ≥40 meets or exceeds 60%. | Baseline (day 1) and Three weeks after 2nd vaccination (day 43) |
| The Percentages Of Subjects Achieving Seroconversion Against A/H5N1 Strain. | Immunogenicity was measured in terms of the percentages of subjects achieving seroconversion or significant increase in HI titer against the vaccine strain, three weeks after receiving two injections of low dose or high dose of aH5N1c vaccine according to the CBER criterion. Seroconversion is defined as, a postvaccination titer ≥40 in subjects with a prevaccination HI titer <10; or in subjects with prevaccination HI titer ≥10, a minimum four-fold rise in postvaccination HI antibody titer. The CBER criterion for the elderly population is met if the lower limit of the two-sided 95% CI for the percentages of subjects achieving seroconversion for HI antibody titer meets or exceeds 30%. | Three weeks after 2nd vaccination (day 43) |
| Number of Subjects Reporting Solicited Local and Systemic Adverse Events, After Any Vaccination. | Safety was assessed as the number of subjects who reported solicited local and systemic adverse events following vaccination with either low or high dose of aH5N1c vaccine. | From day 1 through day 7 after any vaccination. |
| Number of Subjects Reporting Unsolicited Adverse Events After Any Vaccination. | Safety was assessed using the number of subjects who reported any unsolicited adverse events, adverse events possibly or probably related to study vaccine, serious adverse events (SAEs), new onset of chronic diseases (NOCDs), medically attended AEs, AEs of special interest (AESIs), AEs leading to withdrawal from study following vaccination with aH5N1c vaccine |
| Measure | Description | Time Frame |
|---|---|---|
| Geometric Mean Ratios (GMR) Against A/H5N1 Strain Following 2-dose Vaccination Schedule of Either Low Dose or High Dose aH5N1c Vaccine. | Immunogenicity was measured as the GMR. The ratio of postvaccination to prevaccination HI geometric mean titers (GMTs) is reported. The criterion is met according to the European Committee for Medicinal Products for Human Use (CHMP) criterion if the geometric mean increase GMR (day 43/day 1) in HI antibody titer is >2.0 for subjects >60 years of age. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Novartis vaccines and Diagnostics | Novartis Vaccines | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 1 Tatum Highlands Med Ass PLLC | Phoenix | Arizona | 85253 | United States | ||
| 5 Broward Research Group Pembroke Pines |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30968056 | Derived | Frey SE, Shakib S, Chanthavanich P, Richmond P, Smith T, Tantawichien T, Kittel C, Jaehnig P, Mojares Z, Verma B, Kanesa-Thasan N, Hohenboken M. Safety and Immunogenicity of MF59-Adjuvanted Cell Culture-Derived A/H5N1 Subunit Influenza Virus Vaccine: Dose-Finding Clinical Trials in Adults and the Elderly. Open Forum Infect Dis. 2019 Mar 1;6(4):ofz107. doi: 10.1093/ofid/ofz107. eCollection 2019 Apr. |
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All enrolled subjects were included in the trial.
1393 subjects were enrolled at 12 centers in the US, 5 centers in Australia, 2 centers in New Zealand and 4 centers in Thailand.
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| ID | Title | Description |
|---|---|---|
| FG000 | High Dose | Subjects received 2 injections of a high dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart. |
| FG001 | Low Dose | Subjects received 2 injections of a low dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
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| Day 1 through day 387 after any vaccination |
| Day 1; day 22; day 43 and day 387 |
| Percentages Of Subjects With HI Titers ≥40 Against A/H5N1 Strain | Immunogenicity was assessed in terms of percentage of subjects achieving HI titers >40, three weeks after second vaccination with aH5N1c according to the CHMP criterion. The European Licensure (CHMP) criterion is met if the percentage of subjects achieving HI titers ≥40 is >60%. | Day 1, day 22, day 43 and day 387. |
| The Percentages Of Subjects Achieving Seroconversion Against A/H5N1 Strain | Immunogenicity was assessed in terms of percentages of subjects achieving seroconversion in HI titers, three weeks after receiving two injections of either low dose or high dose aH5N1c vaccine according to the CHMP criterion. Seroconversion is defined as a postvaccination titer ≥40 in subjects with a prevaccination HI titer <10; or in subjects with prevaccination HI titer ≥10, a minimum four-fold rise in postvaccination HI antibody titer. The criterion is met according to the European (CHMP) guideline if the percentage of subjects achieving seroconversion is >30%. | Day 22, day 43 and day 387 |
| Hollywood |
| Florida |
| 33024 |
| United States |
| 7 Heartland Rsrch Ass LLC | Wichita | Kansas | 67207 | United States |
| 9 Heartland Research Associates | Wichita | Kansas | 67207 | United States |
| 2 Mercy Health Research | St Louis | Missouri | 63141 | United States |
| 3 Saint Louis University | St Louis | Missouri | 63141 | United States |
| 6 Regional Clinical Research Endwell, | Endwell | New York | 13760 | United States |
| 4 Benchmark Medical Research | Austin | Texas | 78705 | United States |
| 12 Tekton Research | Georgetown | Texas | 78745 | United States |
| 8 J. Lewis Research Inc. | Salt Lake City | Utah | 84109 | United States |
| 10 Foothill Family Clinic | South Cottonwood Heights | Utah | 84121 | United States |
| 11 Jordan River Family Medicine | South Jordan | Utah | 84095 | United States |
| 42 Hunter Clinical Research | Newcastle | New South Wales | 2292 | Australia |
| 44 Wesley Research Institute Clinical Trials Center | Auchenflower | Queensland | 4066 | Australia |
| 40 CMAX | Adelaide | South Australia | 5000 | Australia |
| 41 Linear Clinical Research | Nedlands | Western Australia | 6009 | Australia |
| 45 Childrens Clin Rsrch Facility | Perth | Western Australia | 6872 | Australia |
| 50 Southern Clinical Trials | Beckenham | Christchurch | 8244 | New Zealand |
| 51 Riccarton Clinic | Riccarton | Christchurch | 8041 | New Zealand |
| 72 Faculty of Medicine, Chulalongkorn University - Queen Saovabha Memorial Institute | Bangkok | 10330 | Thailand |
| 71 Phramongkutklao Hospital | Bangkok | 10400 | Thailand |
| 73 Siriraj Clinical Research Ctr | Bangkok | 10700 | Thailand |
| 74 Chiang Mai Uni Hospital Clinical Trial Center | Bangkok | 50200 | Thailand |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Analysis was done on All Enrolled population.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | High Dose | Subjects received 2 injections of a high dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart. |
| BG001 | Low Dose | Subjects received 2 injections of a low dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart. |
| 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 | year |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| 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 | The Percentages Of Subjects Achieving Hemagglutination Inhibition (HI) Titers ≥40 Against A/H5N1 Strain. | The optimal aH5N1c vaccine formulation was evaluated in terms of percentages of subjects achieving HI titers ≥40 against homologous A/H5N1 strain, three weeks after second vaccination with either low dose or high dose of aH5N1c vaccine, according to the Center for Biologics Evaluation and Research (CBER) criterion. The CBER criterion for the elderly population is met if the lower limit of the two-sided 95% confidence interval (CI) for the percentages of subjects achieving HI titer ≥40 meets or exceeds 60%. | Analysis was done on the Full Analysis Set (FAS) i.e., subjects who actually receive at least one dose of study vaccination and provide at least one evaluable serum sample both before (baseline) and after vaccination. | Posted | Number | 95% Confidence Interval | Percentages of subjects | Baseline (day 1) and Three weeks after 2nd vaccination (day 43) |
|
|
| |||||||||||||||||||||||||||||||||||
| Primary | The Percentages Of Subjects Achieving Seroconversion Against A/H5N1 Strain. | Immunogenicity was measured in terms of the percentages of subjects achieving seroconversion or significant increase in HI titer against the vaccine strain, three weeks after receiving two injections of low dose or high dose of aH5N1c vaccine according to the CBER criterion. Seroconversion is defined as, a postvaccination titer ≥40 in subjects with a prevaccination HI titer <10; or in subjects with prevaccination HI titer ≥10, a minimum four-fold rise in postvaccination HI antibody titer. The CBER criterion for the elderly population is met if the lower limit of the two-sided 95% CI for the percentages of subjects achieving seroconversion for HI antibody titer meets or exceeds 30%. | This analysis was done on the FAS. | Posted | Number | 95% Confidence Interval | Percentages of subjects | Three weeks after 2nd vaccination (day 43) |
| |||||||||||||||||||||||||||||||||||||
| Primary | Number of Subjects Reporting Solicited Local and Systemic Adverse Events, After Any Vaccination. | Safety was assessed as the number of subjects who reported solicited local and systemic adverse events following vaccination with either low or high dose of aH5N1c vaccine. | Analysis was done on the solicited safety population, i.e. All subjects in the exposed set with solicited (local/systemic) AE data.. | Posted | Number | Number of subjects | From day 1 through day 7 after any vaccination. |
|
| |||||||||||||||||||||||||||||||||||||
| Primary | Number of Subjects Reporting Unsolicited Adverse Events After Any Vaccination. | Safety was assessed using the number of subjects who reported any unsolicited adverse events, adverse events possibly or probably related to study vaccine, serious adverse events (SAEs), new onset of chronic diseases (NOCDs), medically attended AEs, AEs of special interest (AESIs), AEs leading to withdrawal from study following vaccination with aH5N1c vaccine | Analysis was done unsolicited safety population, i.e. subjects in the exposed set with unsolicited AE data. | Posted | Number | Number of subjects | Day 1 through day 387 after any vaccination |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Geometric Mean Ratios (GMR) Against A/H5N1 Strain Following 2-dose Vaccination Schedule of Either Low Dose or High Dose aH5N1c Vaccine. | Immunogenicity was measured as the GMR. The ratio of postvaccination to prevaccination HI geometric mean titers (GMTs) is reported. The criterion is met according to the European Committee for Medicinal Products for Human Use (CHMP) criterion if the geometric mean increase GMR (day 43/day 1) in HI antibody titer is >2.0 for subjects >60 years of age. | Analysis was done on the FAS. | Posted | Geometric Mean | 95% Confidence Interval | Ratio | Day 1; day 22; day 43 and day 387 |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Percentages Of Subjects With HI Titers ≥40 Against A/H5N1 Strain | Immunogenicity was assessed in terms of percentage of subjects achieving HI titers >40, three weeks after second vaccination with aH5N1c according to the CHMP criterion. The European Licensure (CHMP) criterion is met if the percentage of subjects achieving HI titers ≥40 is >60%. | Analysis was done on the FAS. | Posted | Number | 95% Confidence Interval | Percentages of subjects | Day 1, day 22, day 43 and day 387. |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | The Percentages Of Subjects Achieving Seroconversion Against A/H5N1 Strain | Immunogenicity was assessed in terms of percentages of subjects achieving seroconversion in HI titers, three weeks after receiving two injections of either low dose or high dose aH5N1c vaccine according to the CHMP criterion. Seroconversion is defined as a postvaccination titer ≥40 in subjects with a prevaccination HI titer <10; or in subjects with prevaccination HI titer ≥10, a minimum four-fold rise in postvaccination HI antibody titer. The criterion is met according to the European (CHMP) guideline if the percentage of subjects achieving seroconversion is >30%. | Analysis was done on the FAS. | Posted | Number | 95% Confidence Interval | Percentages of subjects | Day 22, day 43 and day 387 |
|
|
Solicited local and systemic adverse events were collected from day 1 to 7. Unsolicited AEs (other than SAEs) and SAEs were collected from day 1 to 387.
All Solicited AEs-systematic assessment and all unsolicited AEs-non-systematic assessment.
Type II reactions are reported for solicited AEs. Total number of subjects enrolled was - High dose: 700 and Low dose: 693. Total number of subjects who received a study vaccination and included in safety set was - High dose: 699 and Low dose: 689
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | High Dose | Subjects received 2 injections of a high dose MF59 adjuvanted cell-culture derived monovalent H5N1 vaccine three weeks apart. | 43 | 699 | 481 | 699 | ||
| EG001 | Low Dose | Subjects received 2 injections of a low dose MF59 adjuvanted cell-culture derived monovalent H5N1 three weeks apart. | 51 | 689 | 427 | 689 | ||
| EG002 | Total | Total of subjects in both high and low dose groups. | 94 | 1,388 | 908 | 1,388 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ACUTE MYOCARDIAL INFARCTION | Cardiac disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| ANGINA UNSTABLE | Cardiac disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| ATRIAL FIBRILLATION | Cardiac disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| ATRIAL FLUTTER | Cardiac disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| ATRIOVENTRICULAR BLOCK COMPLETE | Cardiac disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| CARDIAC FAILURE CONGESTIVE | Cardiac disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| CORONARY ARTERY DISEASE | Cardiac disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| MYOCARDIAL INFARCTION | Cardiac disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| PERICARDIAL EFFUSION | Cardiac disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| PERICARDITIS | Cardiac disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| SICK SINUS SYNDROME | Cardiac disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| STRESS CARDIOMYOPATHY | Cardiac disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| VERTIGO POSITIONAL | Ear and labyrinth disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| CATARACT | Eye disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| DUODENAL ULCER HAEMORRHAGE | Gastrointestinal disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| DUODENAL ULCER PERFORATION | Gastrointestinal disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| ENTERITIS | Gastrointestinal disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| EPIPLOIC APPENDAGITIS | Gastrointestinal disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| HAEMORRHOIDS | Gastrointestinal disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| INGUINAL HERNIA | Gastrointestinal disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| INTESTINAL OBSTRUCTION | Gastrointestinal disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| SMALL INTESTINAL OBSTRUCTION | Gastrointestinal disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| UPPER GASTROINTESTINAL HAEMORRHAGE | Gastrointestinal disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| CHEST DISCOMFORT | General disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| CHEST PAIN | General disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| PYREXIA | General disorders | MedDRA (17.0) | Systematic Assessment |
| |
| CHOLECYSTITIS | Hepatobiliary disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| DRUG HYPERSENSITIVITY | Immune system disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| ANAL ABSCESS | Infections and infestations | MedDRA (17.0) | Non-systematic Assessment |
| |
| DIVERTICULITIS | Infections and infestations | MedDRA (17.0) | Non-systematic Assessment |
| |
| MENINGITIS VIRAL | Infections and infestations | MedDRA (17.0) | Non-systematic Assessment |
| |
| PNEUMONIA | Infections and infestations | MedDRA (17.0) | Non-systematic Assessment |
| |
| POST PROCEDURAL INFECTION | Infections and infestations | MedDRA (17.0) | Non-systematic Assessment |
| |
| URINARY TRACT INFECTION | Infections and infestations | MedDRA (17.0) | Non-systematic Assessment |
| |
| WOUND INFECTION | Infections and infestations | MedDRA (17.0) | Non-systematic Assessment |
| |
| ANKLE FRACTURE | Injury, poisoning and procedural complications | MedDRA (17.0) | Non-systematic Assessment |
| |
| CLAVICLE FRACTURE | Injury, poisoning and procedural complications | MedDRA (17.0) | Non-systematic Assessment |
| |
| CONCUSSION | Injury, poisoning and procedural complications | MedDRA (17.0) | Non-systematic Assessment |
| |
| FALL | Injury, poisoning and procedural complications | MedDRA (17.0) | Non-systematic Assessment |
| |
| HEAD INJURY | Injury, poisoning and procedural complications | MedDRA (17.0) | Non-systematic Assessment |
| |
| HUMERUS FRACTURE | Injury, poisoning and procedural complications | MedDRA (17.0) | Non-systematic Assessment |
| |
| MULTIPLE FRACTURES | Injury, poisoning and procedural complications | MedDRA (17.0) | Non-systematic Assessment |
| |
| RIB FRACTURE | Injury, poisoning and procedural complications | MedDRA (17.0) | Non-systematic Assessment |
| |
| STERNAL FRACTURE | Injury, poisoning and procedural complications | MedDRA (17.0) | Non-systematic Assessment |
| |
| TRAUMATIC HAEMOTHORAX | Injury, poisoning and procedural complications | MedDRA (17.0) | Non-systematic Assessment |
| |
| WRIST FRACTURE | Injury, poisoning and procedural complications | MedDRA (17.0) | Non-systematic Assessment |
| |
| DYSLIPIDAEMIA | Metabolism and nutrition disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| ARTHRALGIA | Musculoskeletal and connective tissue disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| BACK PAIN | Musculoskeletal and connective tissue disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| MUSCULOSKELETAL CHEST PAIN | Musculoskeletal and connective tissue disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| OSTEOARTHRITIS | Musculoskeletal and connective tissue disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| ROTATOR CUFF SYNDROME | Musculoskeletal and connective tissue disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| BONE CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (17.0) | Non-systematic Assessment |
| |
| ENDOMETRIAL ADENOCARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (17.0) | Non-systematic Assessment |
| |
| HEPATIC CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (17.0) | Non-systematic Assessment |
| |
| LENTIGO MALIGNA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (17.0) | Non-systematic Assessment |
| |
| LUNG ADENOCARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (17.0) | Non-systematic Assessment |
| |
| LUNG NEOPLASM MALIGNANT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (17.0) | Non-systematic Assessment |
| |
| MALIGNANT MELANOMA IN SITU | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (17.0) | Non-systematic Assessment |
| |
| MENINGIOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (17.0) | Non-systematic Assessment |
| |
| PROSTATE CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (17.0) | Non-systematic Assessment |
| |
| BASAL GANGLIA INFARCTION | Nervous system disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| BRAIN STEM INFARCTION | Nervous system disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| CAROTID ARTERY DISEASE | Nervous system disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| CEREBRAL INFARCTION | Nervous system disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| CEREBROVASCULAR ACCIDENT | Nervous system disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| EMBOLIC STROKE | Nervous system disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| HEADACHE | Nervous system disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| ISCHAEMIC STROKE | Nervous system disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| METABOLIC ENCEPHALOPATHY | Nervous system disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| SYNCOPE | Nervous system disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| TRANSIENT ISCHAEMIC ATTACK | Nervous system disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| VIITH NERVE PARALYSIS | Nervous system disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| GRIEF REACTION | Psychiatric disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| SUICIDAL IDEATION | Psychiatric disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| NEPHROLITHIASIS | Renal and urinary disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| RENAL COLIC | Renal and urinary disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| RENAL FAILURE ACUTE | Renal and urinary disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| RECTOCELE | Reproductive system and breast disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| UTERINE POLYP | Reproductive system and breast disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| HYPOXIA | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| PULMONARY EMBOLISM | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| PULMONARY MASS | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| ECCHYMOSIS | Skin and subcutaneous tissue disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| PSORIASIS | Skin and subcutaneous tissue disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| HIP ARTHROPLASTY | Surgical and medical procedures | MedDRA (17.0) | Non-systematic Assessment |
| |
| AORTIC ANEURYSM | Vascular disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| AORTIC STENOSIS | Vascular disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| HYPERTENSIVE CRISIS | Vascular disorders | MedDRA (17.0) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| NAUSEA | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| FATIGUE | General disorders | MedDRA (17.0) | Systematic Assessment |
| |
| INJECTION SITE PAIN | General disorders | MedDRA (17.0) | Systematic Assessment |
| |
| MALAISE | General disorders | MedDRA (17.0) | Systematic Assessment |
| |
| UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA (17.0) | Non-systematic Assessment |
| |
| EATING DISORDER | Psychiatric disorders | MedDRA (17.0) | Systematic Assessment |
| |
| ARTHRALGIA | Musculoskeletal and connective tissue disorders | MedDRA (17.0) | Systematic Assessment |
| |
| MYALGIA | Musculoskeletal and connective tissue disorders | MedDRA (17.0) | Systematic Assessment |
| |
| HEADACHE | Nervous system disorders | MedDRA (17.0) | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Posting Director | Novartis Vaccines | RegistryContactVaccinesUS@novartis.com |
| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| D005585 | Influenza in Birds |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |
| D001715 | Bird Diseases |
| D000820 | Animal Diseases |
Not provided
Not provided
| MALE |
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| Units | Counts |
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| Participants |
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| Participants |
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