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| ID | Type | Description | Link |
|---|---|---|---|
| EUDRACT: 2005-001902-26 |
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| Name | Class |
|---|---|
| Novartis Vaccines and Diagnostics S.r.l. | UNKNOWN |
The purpose of the study is to evaluate safety, tolerability and immunogenicity (in a subset) following a dose of a trivalent subunit influenza vaccine produced either in mammalian cells or in embryonated hen eggs, in healthy adult and elderly subjects who received either vaccine one year before (2004) in the study V58P4.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| cTIV\cTIV (adults) | Active Comparator | Subjects (18-60 years of age) previously vaccinated with cell-derived influenza vaccine (cTIV), received one dose of cell-derived trivalent influenza vaccine (cTIV) one year later, in this study. |
|
| cTIV\TIV (adults) | Active Comparator | Subjects (18-60 years of age) previously vaccinated with cell-derived influenza vaccine (cTIV), received one dose of an egg-derived trivalent influenza vaccine (TIV) one year later, in this study. |
|
| cTIV\cTIV (elderly) | Active Comparator | Subjects (≥61 years of age) previously vaccinated with cell-derived influenza vaccine (cTIV), received one dose of cell-derived trivalent influenza vaccine (cTIV) one year later, in this study. |
|
| cTIV\TIV (elderly) | Active Comparator | Subjects (≥61years of age) previously vaccinated with cell-derived influenza vaccine (cTIV), received one dose of an egg-derived trivalent influenza vaccine (TIV) one year later, in this study. |
|
| TIV\TIV (adults) | Active Comparator |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cell culture derived influenza vaccine | Biological | as a single IM injection of 0.5 ml in the deltoid muscle, preferably of the non-dominant arm |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine | To assess the safety and tolerability in terms of number of adult and elderly subjects reporting solicited adverse events following one dose of the cTIV or the TIV vaccine . | Day 1 to Day 7 postvaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Six-months Safety Data of Subjects After One Dose of Cell Culture Derived or Egg-derived Influenza Vaccine | To collect additional safety data for 6 months after vaccination with one dose of cell culture derived or egg-derived influenza vaccine in terms of serious adverse events (SAEs), adverse events (AEs) necessitating a physician's visit and/or resulting in premature subject's withdrawal from study. |
Not provided
Inclusion Criteria:
18 to < 61 years of age (first age group) OR 61 years of age and older (second age group) at enrolment in V58P4
Mentally competent to understand the nature, the scope and the consequences of the study
Able and willing to give written informed consent prior to study entry
Available for all the visits scheduled in the study
in good health as determined by:
Exclusion Criteria:
Unwilling or unable to give written informed consent to participate in the study
Currently experiencing an acute infectious disease
Any serious disease such as, for example:
Surgery planned during the study period
Bleeding diathesis
History of hypersensitivity to any component of the study medication or chemically related substances, such as allergy to eggs or egg products
Known or suspected impairment/alteration of immune function resulting from:
History of drug or alcohol abuse
Laboratory confirmed influenza disease in the past 6 months
Received influenza vaccine within the past 6 months
Received another vaccine or any investigational agent within the past 60 days, or expect to receive another vaccine within 3 weeks following the study vaccination
Participation in another clinical trial within 90 days prior to enrollment and throughout the full length of the study
Any acute respiratory disease or infections requiring systemic antibiotic or antiviral therapy (chronic antibiotic therapy for urinary tract prophylaxis is acceptable) or experienced fever _ 38°C within the past 5 days
Pregnant/ breast feeding women or women who refuse to use a reliable contraceptive method during the first three weeks after vaccination
Any condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives.
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Vaccines and Diagnostics | Novartis Vaccines | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wojewódzki Szpital Dzieci_cy | Ul. Langiewicza 2 | Kielce | 25-381 | Poland | ||
| Centrum Bada_ Farmakologii Klinicznej |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22418809 | Result | Szymczakiewicz-Multanowska A, Lattanzi M, Izu A, Casula D, Sparacio M, Kovacs C, Groth N. Safety assessment and immunogenicity of a cell-culture-derived influenza vaccine in adults and elderly subjects over three successive influenza seasons. Hum Vaccin Immunother. 2012 May;8(5):645-52. doi: 10.4161/hv.19493. Epub 2012 May 1. |
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All subjects enrolled were included in the trial.
Subjects were enrolled from 5 study centers in Poland.
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| ID | Title | Description |
|---|---|---|
| FG000 | Adults (cTIV\cTIV) + (TIV\cTIV) | Subjects (18-60 years of age) who previously received one dose of either cell-derived (cTIV) or egg derived (TIV) trivalent influenza vaccine received one dose of cTIV in this study, one year later. |
| FG001 | Adults (cTIV\TIV) + (TIV\TIV) | Subjects (18-60 years of age) who previously received one dose of either cell-derived (cTIV) or egg derived (TIV) trivalent influenza vaccine received one dose of TIV in this study, one year later. |
| FG002 | Elderly (cTIV\cTIV) + (TIV\cTIV) | Subjects(≥61years of age ) who previously received one dose of either cell-derived (cTIV) or egg derived (TIV) trivalent influenza vaccine received one dose of cTIV in this study, one year later. |
| FG003 | Elderly (cTIV\TIV) + (TIV\TIV) | Subjects (≥61years) who previously received one dose of either cell-derived (cTIV) or egg derived (TIV) trivalent influenza vaccine received one dose of TIV in this study, one year later. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Adults (cTIV\cTIV) + (TIV\cTIV) | Subjects(18-60 years of age) who previously received one dose of either cell-derived (cTIV) or egg derived (TIV) trivalent influenza vaccine, received one dose of cTIV in this study, one year later. |
| BG001 | Elderly (cTIV\cTIV) + (TIV\cTIV) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | Six-months Safety Data of Subjects After One Dose of Cell Culture Derived or Egg-derived Influenza Vaccine | To collect additional safety data for 6 months after vaccination with one dose of cell culture derived or egg-derived influenza vaccine in terms of serious adverse events (SAEs), adverse events (AEs) necessitating a physician's visit and/or resulting in premature subject's withdrawal from study. | This analysis was done on the safety dataset. | Posted | Number | Participants | Up to 6 months postvaccination |
|
Through out the study period
Post-injection solicited adverse events were collected from Day 1-7. Other AEs and SAEs were collected through out the study period (Day 1 to 6 months).
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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 | Adults (cTIV\cTIV) + (TIV\cTIV) | Subjects(18-60 years of age) who previously received one dose of either cell-derived (cTIV) or egg derived (TIV) trivalent influenza vaccine received one dose of cTIV in this study, one year later. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute myocardial infraction | Cardiac disorders | MedDRA | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fatigue | General disorders | MedDRA | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Posting Director | Novartis Vaccines and Diagnostics | RegistryContactVaccinesUS@novartis.com |
Not provided
| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
Not provided
Not provided
Not provided
Not provided
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Not provided
Subjects (18-60 years of age) previously vaccinated with egg-derived influenza vaccine (TIV), received one dose of egg-derived trivalent influenza vaccine (TIV) one year later, in this study. |
|
| TIV\cTIV (adults) | Active Comparator | Subjects (18-60 years of age) previously vaccinated with egg-derived influenza vaccine (TIV), received one dose of cell-derived trivalent influenza (cTIV) one year later, in this study. |
|
| TIV\TIV (elderly) | Active Comparator | Subjects (≥61 years of age) previously vaccinated with egg-derived influenza vaccine (TIV), received one dose of egg-derived trivalent influenza vaccine (TIV) one year later, in this study. |
|
| TIV\cTIV (elderly) | Active Comparator | Subjects (≥61 years of age) previously vaccinated with egg-derived influenza vaccine (TIV), received one dose of cell-derived trivalent influenza (cTIV) one year later, in this study. |
|
| egg-derived influenza subunit vaccine | Biological | as a single IM injection of 0.5 ml in the deltoid muscle, preferably of the non-dominant arm |
|
| Up to 6 months postvaccination |
| Geometric Mean Titers (GMTs) After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine in Adult and Elderly Subjects | The haemagglutinin inhibition (HI) antibody titer response following one 0.5 mL dose of either cell derived (cTIV) or egg-derived vaccine (TIV) in adult and elderly subjects is reported as GMTs. The HI GMTs were evaluated using egg-derived antigen assay. | Day 22 postvaccination |
| Geometric Mean Ratios (GMRs), After One Dose of the Cell Culture-derived or the Egg-derived Influenza Vaccine in Adult and Elderly Subjects | Immunogenicity was assessed in terms of GMR in adult and elderly subjects following one 0.5ml dose of either the cTIV vaccine or the TIV vaccine, according to the CHMP criteria. The European licensure (CHMP) criteria was met if the mean geometric increase (GMR, day 22/day 1) in HI antibody titer is >2.5 for adults and >2.0 for elderly subjects. | Day 22 postvaccination |
| Percentages of Adult and Elderly Subjects Achieving HI Titers ≥ 40 After One Dose of the Cell Culture-derived or the Egg-derived Influenza Vaccine. | Immunogenicity was assessed in terms of percentages of adult and elderly subjects achieving HI titers≥40,after one dose of either the cTIV vaccine or the TIV vaccine. European (CHMP) criteria is met if the percentage of subjects achieving HI titers ≥ 40 is > 70% for adults and >60% for elderly. | Day 22 postvaccination |
| Percentages of Adult and Elderly Subjects With Seroconversion or Significant Increase in HI Antibody Titers After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine. | Immunogenicity was assessed in terms of percentages of adult and elderly subjects showing seroconversion or significant increase in HI antibody titers after one dose of cell culture-derived or the egg-derived influenza vaccine. Seroconversion or significant increase as per European Licensure (CHMP) criteria is defined as percentage of subjects with a prevaccination HI titer <10 to a postvaccination titer ≥ 40 for adults and ≥ 30 for elderly. Significant increase is defined as percentage of subjects with a prevaccination HI titer ≥ 10 and a ≥ 4-fold increase in postvaccination HI antibody titer. | Day 22 postvaccination |
| Ul. Ujastek 3 |
| Krakow |
| 30-969 |
| Poland |
| NZOZ Jagiello_skie | Centrum Medyczne Sp. Z O.o., O_. Jagiello_skie 1 | Kraków | 31-832 | Poland |
| NZOZ Praktyka Grupowa Lekarzy Rodzinnych, "Familia" Sp. z o.o. | Pl. Sikorskiego 6a | Kraków | 31-115 | Poland |
| Szpital Jana Pawła II, Oddz. Neuroinfekcji | Ul. Pr_dnicka 80 | Kraków | 31-202 | Poland |
| Withdrawal by Subject |
|
| Adverse Event |
|
| Death |
|
Subjects(≥61 years of age) who previously received one dose of either cell-derived (cTIV) or egg derived (TIV) trivalent influenza vaccine, received one dose of cTIV in this study, one year later. |
| BG002 | Adults (cTIV\TIV) + (TIV\TIV) | Subjects (18-60 years of age) who previously received one dose of either cell-derived (cTIV) or egg derived (TIV) trivalent influenza vaccine received one dose of TIV in this study, one year later. |
| BG003 | Elderly (cTIV\TIV) + (TIV\TIV) | Subjects (≥61 years of age) who previously received one dose of either cell-derived (cTIV) or egg derived (TIV) trivalent influenza vaccine received one dose of TIV in this study, one year later. |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| cTIV\TIV (Adults) |
Subjects (18-60 years of age) previously vaccinated with cell-derived influenza vaccine (cTIV), received one dose of an egg-derived trivalent influenza vaccine (TIV) one year later, in this study. |
| OG002 | cTIV\cTIV (Elderly) | Subjects (≥61years of age) previously vaccinated with cell-derived influenza vaccine (cTIV), received one dose of cell-derived trivalent influenza vaccine (cTIV) one year later, in this study. |
| OG003 | cTIV\TIV (Elderly) | Subjects (≥61years of age) previously vaccinated with cell-derived influenza vaccine (cTIV), received one dose of an egg-derived trivalent influenza vaccine (TIV) one year later, in this study. |
| OG004 | TIV\TIV (Adults) | Subjects (18-60 years of age) previously vaccinated with egg-derived influenza vaccine (TIV), received one dose of egg-derived trivalent influenza vaccine (TIV) one year later, in this study. |
| OG005 | TIV\cTIV (Adults) | Subjects (18-60 years of age) previously vaccinated with egg-derived influenza vaccine (TIV), received one dose of cell-derived trivalent influenza (cTIV) one year later, in this study. |
| OG006 | TIV\TIV (Elderly) | Subjects (≥61years of age) previously vaccinated with egg-derived influenza vaccine (TIV), received one dose of egg-derived trivalent influenza vaccine (TIV) one year later, in this study. |
| OG007 | TIV\cTIV (Elderly) | Subjects (≥61years of age) previously vaccinated with egg-derived influenza vaccine (TIV), received one dose of cell-derived trivalent influenza (cTIV) one year later, in this study. |
|
|
| Secondary | Geometric Mean Titers (GMTs) After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine in Adult and Elderly Subjects | The haemagglutinin inhibition (HI) antibody titer response following one 0.5 mL dose of either cell derived (cTIV) or egg-derived vaccine (TIV) in adult and elderly subjects is reported as GMTs. The HI GMTs were evaluated using egg-derived antigen assay. | The analysis was done on the immunogenicity subset. | Posted | Geometric Mean | 95% Confidence Interval | Titers | Day 22 postvaccination |
|
|
|
| Secondary | Geometric Mean Ratios (GMRs), After One Dose of the Cell Culture-derived or the Egg-derived Influenza Vaccine in Adult and Elderly Subjects | Immunogenicity was assessed in terms of GMR in adult and elderly subjects following one 0.5ml dose of either the cTIV vaccine or the TIV vaccine, according to the CHMP criteria. The European licensure (CHMP) criteria was met if the mean geometric increase (GMR, day 22/day 1) in HI antibody titer is >2.5 for adults and >2.0 for elderly subjects. | The analysis was done on the immunogenicity subset. | Posted | Geometric Mean | 95% Confidence Interval | Ratio | Day 22 postvaccination |
|
|
|
| Secondary | Percentages of Adult and Elderly Subjects Achieving HI Titers ≥ 40 After One Dose of the Cell Culture-derived or the Egg-derived Influenza Vaccine. | Immunogenicity was assessed in terms of percentages of adult and elderly subjects achieving HI titers≥40,after one dose of either the cTIV vaccine or the TIV vaccine. European (CHMP) criteria is met if the percentage of subjects achieving HI titers ≥ 40 is > 70% for adults and >60% for elderly. | This analysis was done on immunogenicity subset. | Posted | Number | 95% Confidence Interval | Percentages of subjects | Day 22 postvaccination |
|
|
|
| Secondary | Percentages of Adult and Elderly Subjects With Seroconversion or Significant Increase in HI Antibody Titers After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine. | Immunogenicity was assessed in terms of percentages of adult and elderly subjects showing seroconversion or significant increase in HI antibody titers after one dose of cell culture-derived or the egg-derived influenza vaccine. Seroconversion or significant increase as per European Licensure (CHMP) criteria is defined as percentage of subjects with a prevaccination HI titer <10 to a postvaccination titer ≥ 40 for adults and ≥ 30 for elderly. Significant increase is defined as percentage of subjects with a prevaccination HI titer ≥ 10 and a ≥ 4-fold increase in postvaccination HI antibody titer. | This analysis was done on the immunogenicity subset. | Posted | Number | 95% Confidence Interval | Percentages of subjects | Day 22 postvaccination |
|
|
|
| Primary | Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine | To assess the safety and tolerability in terms of number of adult and elderly subjects reporting solicited adverse events following one dose of the cTIV or the TIV vaccine . | This analysis was done on safety dataset | Posted | Number | Participants | Day 1 to Day 7 postvaccination |
|
|
|
| 9 |
| 533 |
| 188 |
| 533 |
| EG001 | Adults (cTIV/TIV) + (TIV\TIV) | Subjects (18-60 years of age) who previously received one dose of either cell-derived (cTIV) or egg derived (TIV) trivalent influenza vaccine received one dose of TIV in this study, one year later. | 4 | 534 | 172 | 534 |
| EG002 | Elderly (cTIV\cTIV) + (TIV\cTIV) | Subjects(≥61 years of age) who previously received one dose of either cell-derived (cTIV) or egg derived (TIV) trivalent influenza vaccine received one dose of cTIV in this study, one year later. | 23 | 571 | 140 | 571 |
| EG003 | Elderly (cTIV\TIV) + (TIV\TIV) | Subjects (≥61 years of age) who previously received one dose of either cell-derived (cTIV) or egg derived (TIV) trivalent influenza vaccine received one dose of TIV in this study, one year later. | 30 | 597 | 148 | 597 |
| Adams stokes syndrome | Cardiac disorders | MedDRA | Non-systematic Assessment |
|
| Angina unstable | Cardiac disorders | MedDRA | Non-systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | MedDRA | Non-systematic Assessment |
|
| Atrioventricular block complete | Cardiac disorders | MedDRA | Non-systematic Assessment |
|
| Atrioventricular block second degree | Cardiac disorders | MedDRA | Non-systematic Assessment |
|
| Conduction disorder | Cardiac disorders | MedDRA | Non-systematic Assessment |
|
| Myocardial ischaemia | Cardiac disorders | MedDRA | Non-systematic Assessment |
|
| Sinus bradycardia | Cardiac disorders | MedDRA | Non-systematic Assessment |
|
| Tachycardia paroxysmal | Cardiac disorders | MedDRA | Non-systematic Assessment |
|
| Hypoacusis | Ear and labyrinth disorders | MedDRA | Non-systematic Assessment |
|
| Cataract | Eye disorders | MedDRA | Non-systematic Assessment |
|
| Abdominal hernia | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Inguinal hernia | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Pancreatitis chronic | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Pancreatitis necrotising | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Peritonitis | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Spilgelian hernia | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Umblical hernia | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Chest pain | General disorders | MedDRA | Non-systematic Assessment |
|
| Inflammation | General disorders | MedDRA | Non-systematic Assessment |
|
| Sudden cardiac death | General disorders | MedDRA | Non-systematic Assessment |
|
| Bile duct stone | Hepatobiliary disorders | MedDRA | Non-systematic Assessment |
|
| Cholelithiasis | Hepatobiliary disorders | MedDRA | Non-systematic Assessment |
|
| Cholecystitis | Hepatobiliary disorders | MedDRA | Non-systematic Assessment |
|
| Bronchitis acute | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Bronchitis chronic | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Bronchopneumonia | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Erysipelas | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Forearm fracture | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
|
| Head injury | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
|
| Radius fracture | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
|
| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
|
| Tendon injury | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
|
| Joint contracture | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
|
| Muscle haemorrhage | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
|
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
|
| Toe deformity | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
|
| Blood electrolytes abnormal | Investigations | MedDRA | Non-systematic Assessment |
|
| Bladder neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Non-systematic Assessment |
|
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Non-systematic Assessment |
|
| Hodgkin's disease | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Non-systematic Assessment |
|
| Lung neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Non-systematic Assessment |
|
| Neoplasm skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Non-systematic Assessment |
|
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Non-systematic Assessment |
|
| Cerebral haemorrhage | Nervous system disorders | MedDRA | Non-systematic Assessment |
|
| Cerebral infraction | Nervous system disorders | MedDRA | Non-systematic Assessment |
|
| Transient ischaemic attack | Nervous system disorders | MedDRA | Non-systematic Assessment |
|
| Completed suicide | Psychiatric disorders | MedDRA | Non-systematic Assessment |
|
| Nephrolithiasis | Renal and urinary disorders | MedDRA | Non-systematic Assessment |
|
| Renal failure | Renal and urinary disorders | MedDRA | Non-systematic Assessment |
|
| Ovarian cyst | Reproductive system and breast disorders | MedDRA | Non-systematic Assessment |
|
| Uterine prolapse | Reproductive system and breast disorders | MedDRA | Non-systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
|
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
|
| Angineurotic oedema | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
|
| Cardiac pacemaker insertion | Surgical and medical procedures | MedDRA | Non-systematic Assessment |
|
| Cardiac pacemaker replacement | Surgical and medical procedures | MedDRA | Non-systematic Assessment |
|
| Cholecystectomy | Surgical and medical procedures | MedDRA | Non-systematic Assessment |
|
| Knee arthroplasty | Surgical and medical procedures | MedDRA | Non-systematic Assessment |
|
| Arteriosclerosis obliterans | Vascular disorders | MedDRA | Non-systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA | Non-systematic Assessment |
|
| Varicose vein | Vascular disorders | MedDRA | Non-systematic Assessment |
|
| Injection site erythema | General disorders | MedDRA | Systematic Assessment |
|
| Injection site induration | General disorders | MedDRA | Systematic Assessment |
|
| Injection site haemorrhage | General disorders | MedDRA | Systematic Assessment |
|
| Injection site pain | General disorders | MedDRA | Systematic Assessment |
|
| Malaise | General disorders | MedDRA | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
|
Not provided
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |
| A/H1N1 strain (Day 22) |
|
| A/H3N2 strain (Day 1) |
|
| A/H3N2 strain (Day 22) |
|
| B strain (Day 1) |
|
| B strain (Day 22) |
|
| A/H3N2 strain |
|
| B strain |
|
| A/H1N1 strain (Day 22) |
|
| A/H3N2 strain (Day 1) |
|
| A/H3N2 strain (Day 22) |
|
| B strain (Day 1) |
|
| B strain (Day 22) |
|
| A/H3N2 strain |
|
| B strain |
|
| Injection site ecchymosis |
|
| Injection site erythema |
|
| Injection site induration |
|
| Injection site swelling |
|
| Injection site pain |
|
| Systemic |
|
| Chills |
|
| Malaise |
|
| Myalgia |
|
| Arthralgia |
|
| Headache |
|
| Sweat |
|
| Fatigue |
|
| Fever (≥38°C) |
|
| Other |
|
| Stayed at home due to reaction |
|
| Analgesic antipyretic medication used |
|