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The present study aims to evaluate the safety and immunogenicity of the new influenza subunit vaccine produced in Madin Darby Canine Kidney (MDCK) cells in healthy adult and elderly subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cell culture-derived influenza vaccine (cTIV) | Experimental |
| |
| Egg-derived influenza virus vaccine (TIV) | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cell culture-derived trivalent subunit influenza vaccine (cTIV) | Biological | One vaccination (0.5 mL) of cell culture-derived influenza vaccine (cTIV) was administered in the deltoid muscle |
| Measure | Description | Time Frame |
|---|---|---|
| Percentages Of Subjects Who Achieved HI Titer ≥40 After One Vaccination of Cell Culture-derived (cTIV) or Egg-derived (TIV) Influenza Subunit Vaccines | Immunogenicity was measured as the percentage of adults (≥18 to ≤60 years) and elderly (≥61 years) achieving HI titers ≥40 at baseline (day 1) and three weeks (day 22) after one vaccination of cTIV or TIV vaccine for each of three vaccine strains, evaluated using the hemagglutination inhibition (HI) egg-derived antigen assay. In compliance with the requirements of the EMEA recommendations (CPMP/BWP/2490/00, CPMP/BWP/214/96), this criterion is met if the percentage of subjects achieving HI titers ≥40 is >70% in the ≥18 to ≤60 years of age group or >60% in the ≥61 years of age group. | Before vaccination (day 1) and three weeks after vaccination (day 22) |
| Percentages Of Subjects Who Achieved Seroconversion Or Significant Increase In HI Titer After One Vaccination of cTIV or TIV | Seroconversion or significant in HI titer is defined as the percentage of subjects with a prevaccination HI titer <10 (negative) to a postvaccination titer ≥40; or in subjects with prevaccination HI titer ≥10, at least a 4-fold increase in postvaccination HI titer. In compliance with the requirements of the EMEA recommendations (CPMP/BWP/2490/00, CPMP/BWP/214/96), the criterion is met if the percentage of subjects achieving seroconversion/significant increase is >40% in the ≥18 to ≤60 years of age group or >30% in the ≥61 years of age group. | Three weeks after vaccination (day 22) |
| Geometric Mean Ratio of Subjects After One Vaccination of cTIV or TIV | Immunogenicity was measured as the geometric mean ratio (GMR), calculated as the ratio of postvaccination to prevaccination HI Geometric Mean Titers (GMTs), three weeks after (day 22) one vaccination of cTIV or TIV. In compliance with the requirements of the EMEA recommendations (CPMP/BWP/2490/00, CPMP/BWP/214/96), this criterion is met if the GMR (day 22/day 1) in HI antibody titer is >2.5 in the ≥18 to ≤60 years of age group or >2.0 in the ≥61 years of age group. | Three weeks after vaccination (day 22) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects Who Reported Solicited Local and Systemic Reactions up to 7 Days After Vaccination | The solicited local and systemic reactions were collected from day 1 up to and including day 7 after vaccination for both the vaccine groups. | Up to 7 days postvaccination |
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Inclusion Criteria:
18 to 60 years of age (first age group) OR over 60 years of age (second age group)
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
residence in the study area
in good health as determined by:
Exclusion Criteria:
unable or unwilling to give written informed consent to participate in the study
suffering from an acute infectious disease
any serious disease such as:
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 planned vaccination within 3 weeks following the study vaccination
any acute respiratory disease or infections requiring systemic antibiotic or antiviral therapy (chronic antibiotic therapy for urinary tract prophylaxis was acceptable) or experienced fever ≥ 38°C within the past 3 days
pregnant women or women who refused to use a reliable contraceptive method throughout the study (180 days)
any condition which, in the opinion of the investigator, might have interfered with the evaluation of the study objectives.
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Vaccines | Novartis Vaccines | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wojewódzki Szpital Dzieciecy | Ul. Langiewicza 2 | Kielce | 25-381 | Poland | ||
| N ZOZ Jagiellonskie, Centrum Medyczne Sp. z o.o. |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19673651 | Result | Szymczakiewicz-Multanowska A, Groth N, Bugarini R, Lattanzi M, Casula D, Hilbert A, Tsai T, Podda A. Safety and immunogenicity of a novel influenza subunit vaccine produced in mammalian cell culture. J Infect Dis. 2009 Sep 15;200(6):841-8. doi: 10.1086/605505. |
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All enrolled subjects were included in the trial.
Subjects were enrolled at 5 sites in Poland.
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| ID | Title | Description |
|---|---|---|
| FG000 | cTIV (Adults) | Subjects ≥18 to ≤60 years of age who received one vaccination of cell culture-derived influenza virus vaccine (cTIV) |
| FG001 | TIV (Adults) | Subjects ≥18 to ≤60 years of age who received one vaccination of egg-derived influenza virus vaccine (TIV) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Egg-derived trivalent subunit influenza vaccine (TIV) | Biological | One vaccination (0.5 mL) of egg-derived influenza virus vaccine (TIV) was administered in the deltoid muscle |
|
| Os. Jagiellonskie 1 |
| Kraków |
| 31-832 |
| Poland |
| Praktyka Grupowa Lekarzy POZ "Familia" | Pl. Sikorskiego 6a | Kraków | 31-115 | Poland |
| Szpital Jana Pawła II | Ul. Pradnicka 80 | Kraków | 31-202 | Poland |
| Centrum Farmakologii Klinicznej | Krakow | 30-969 | Poland |
| FG002 | cTIV (Elderly) | Subjects ≥61 years of age who received one vaccination of cell culture-derived influenza virus vaccine (cTIV) |
| FG003 | TIV (Elderly) | Subjects ≥61 years of age who received one vaccination of egg-derived influenza virus vaccine (TIV) |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | cTIV (Adults) | Subjects ≥18 to ≤60 years of age who received one vaccination of cell culture-derived influenza virus vaccine (cTIV) |
| BG001 | TIV (Adults) | Subjects ≥18 to ≤60 years of age who received one vaccination of egg-derived influenza virus vaccine (TIV) |
| BG002 | cTIV (Elderly) | Subjects ≥61 years of age who received one vaccination of cell culture-derived influenza virus vaccine (cTIV) |
| BG003 | TIV (Elderly) | Subjects ≥61 years of age who received one vaccination of egg-derived influenza virus vaccine (TIV) |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentages Of Subjects Who Achieved HI Titer ≥40 After One Vaccination of Cell Culture-derived (cTIV) or Egg-derived (TIV) Influenza Subunit Vaccines | Immunogenicity was measured as the percentage of adults (≥18 to ≤60 years) and elderly (≥61 years) achieving HI titers ≥40 at baseline (day 1) and three weeks (day 22) after one vaccination of cTIV or TIV vaccine for each of three vaccine strains, evaluated using the hemagglutination inhibition (HI) egg-derived antigen assay. In compliance with the requirements of the EMEA recommendations (CPMP/BWP/2490/00, CPMP/BWP/214/96), this criterion is met if the percentage of subjects achieving HI titers ≥40 is >70% in the ≥18 to ≤60 years of age group or >60% in the ≥61 years of age group. | Analysis was done on the per-protocol (PP) set, i.e. the subjects who received the vaccination correctly; provided evaluable data before and after vaccination; and with no major protocol violations, as defined before unblinding. | Posted | Number | 95% Confidence Interval | Percentages | Before vaccination (day 1) and three weeks after vaccination (day 22) |
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| Primary | Percentages Of Subjects Who Achieved Seroconversion Or Significant Increase In HI Titer After One Vaccination of cTIV or TIV | Seroconversion or significant in HI titer is defined as the percentage of subjects with a prevaccination HI titer <10 (negative) to a postvaccination titer ≥40; or in subjects with prevaccination HI titer ≥10, at least a 4-fold increase in postvaccination HI titer. In compliance with the requirements of the EMEA recommendations (CPMP/BWP/2490/00, CPMP/BWP/214/96), the criterion is met if the percentage of subjects achieving seroconversion/significant increase is >40% in the ≥18 to ≤60 years of age group or >30% in the ≥61 years of age group. | Analysis was performed on the PP set. | Posted | Number | 95% Confidence Interval | Percentages | Three weeks after vaccination (day 22) |
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| Primary | Geometric Mean Ratio of Subjects After One Vaccination of cTIV or TIV | Immunogenicity was measured as the geometric mean ratio (GMR), calculated as the ratio of postvaccination to prevaccination HI Geometric Mean Titers (GMTs), three weeks after (day 22) one vaccination of cTIV or TIV. In compliance with the requirements of the EMEA recommendations (CPMP/BWP/2490/00, CPMP/BWP/214/96), this criterion is met if the GMR (day 22/day 1) in HI antibody titer is >2.5 in the ≥18 to ≤60 years of age group or >2.0 in the ≥61 years of age group. | Analysis was performed on the PP set. | Posted | Number | 95% Confidence Interval | Ratio | Three weeks after vaccination (day 22) |
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| Secondary | Number of Subjects Who Reported Solicited Local and Systemic Reactions up to 7 Days After Vaccination | The solicited local and systemic reactions were collected from day 1 up to and including day 7 after vaccination for both the vaccine groups. | Analysis was done on Safety population i.e., all subjects with vaccination and with some post-baseline safety data. | Posted | Number | Number of Subjects | Up to 7 days postvaccination |
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Throughout the study (day 1 to day 180)
All serious adverse events (AEs) were collected throughout the study (day 1 to day 180).
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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 | cTIV (Adults) | Subjects ≥18 to ≤60 years of age who received one vaccination of cell culture-derived influenza virus vaccine (cTIV) | 7 | 652 | 261 | 652 | ||
| EG001 | TIV (Adults) | Subjects ≥18 to ≤60 years of age who received one vaccination of egg-derived influenza virus vaccine (TIV) | 5 | 648 | 257 | 648 | ||
| EG002 | cTIV (Elderly) | Subjects ≥61 years of age who received one vaccination of cell culture-derived influenza virus vaccine (cTIV) | 19 | 678 | 224 | 678 | ||
| EG003 | TIV (Elderly) | Subjects ≥61 years of age who received one vaccination of egg-derived influenza virus vaccine (TIV) | 18 | 676 | 207 | 676 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute myocardial infarction | Cardiac disorders | Non-systematic Assessment |
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| Atrial fibrillation | Cardiac disorders | Non-systematic Assessment |
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| Hypoacusis | Ear and labyrinth disorders | Non-systematic Assessment |
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| Inguinal hernia | Gastrointestinal disorders | Non-systematic Assessment |
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| Bronchopneumonia | Infections and infestations | Non-systematic Assessment |
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| Alcohol poisoning | Injury, poisoning and procedural complications | Non-systematic Assessment |
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| Postoperative hernia | Injury, poisoning and procedural complications | Non-systematic Assessment |
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| Nephrolithiasis | Renal and urinary disorders | Non-systematic Assessment |
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| Chronic obstructive airways disease | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Angina pectoris | Cardiac disorders | Non-systematic Assessment |
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| Angina unstable | Cardiac disorders | Non-systematic Assessment |
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| Coronary artery disease | Cardiac disorders | Non-systematic Assessment |
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| Myocardial ischaemia | Cardiac disorders | Non-systematic Assessment |
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| Inner ear disorder | Ear and labyrinth disorders | Non-systematic Assessment |
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| Angle closure glaucoma | Eye disorders | Non-systematic Assessment |
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| Retinal detachment | Eye disorders | Non-systematic Assessment |
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| Colitis | Gastrointestinal disorders | Non-systematic Assessment |
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| Diverticulum intestinal | Gastrointestinal disorders | Non-systematic Assessment |
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| Dyspepsia | Gastrointestinal disorders | Non-systematic Assessment |
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| Food poisoning | Gastrointestinal disorders | Non-systematic Assessment |
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| Gastric haemorrhage | Gastrointestinal disorders | Non-systematic Assessment |
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| Pancreatitis acute | Gastrointestinal disorders | Non-systematic Assessment |
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| Cholecystitis acute | Hepatobiliary disorders | Non-systematic Assessment |
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| Pneumonia | Infections and infestations | Non-systematic Assessment |
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| Carbon monoxide poisoning | Injury, poisoning and procedural complications | Non-systematic Assessment |
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| Procedural complication | Injury, poisoning and procedural complications | Non-systematic Assessment |
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| Tibia fracture | Injury, poisoning and procedural complications | Non-systematic Assessment |
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| Osteoarthritis | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Benign oesophageal neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
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| Gallbladder cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
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| Lung adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
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| Lung neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
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| Lung squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
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| Carpal tunnel syndrome | Nervous system disorders | Non-systematic Assessment |
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| Cerebrovascular accident | Nervous system disorders | Non-systematic Assessment |
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| Sleep apnoea syndrome | Nervous system disorders | Non-systematic Assessment |
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| Syncope Vasovagal | Nervous system disorders | Non-systematic Assessment |
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| Uterine polyp | Reproductive system and breast disorders | Non-systematic Assessment |
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| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Atherosclerosis obliterans | Vascular disorders | Non-systematic Assessment |
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| Hypertension | Vascular disorders | Non-systematic Assessment |
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| Hypertensive crisis | Vascular disorders | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection site erythema | General disorders | Systematic Assessment |
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| Injection site induration | General disorders | Systematic Assessment |
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| Injection site pain | General disorders | Systematic Assessment |
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| Malaise | General disorders | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Fatigue | General disorders | Systematic Assessment |
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| Headache | Nervous system disorders | Systematic Assessment |
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| Hyperhidrosis | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Posting Director | Novartis Vaccines and Diagnostics | RegistryContactVaccinesUS@novartis.com |
| 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 |
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| Male |
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| A/H1N1 (Day 22) |
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| A/H3N2 (Day 1) |
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| A/H3N2 (Day 22) |
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| B (Day 1) |
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| B (Day 22) |
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| Non-inferiority testing in immune response (HI titer ≥40) of cTIV to that of TIV vaccine for strain A/H3N2 after one vaccination in adults. | Group difference | 0 | 2-Sided | 95 | -1 | 2 | Yes | Non-Inferiority or Equivalence | The percentage of subjects with HI titer ≥40 in the cTIV group is >10% lower than in the TIV group (i.e., the percentage of subjects with HI titer ≥40 in the cTIV group is non-inferior to that of TIV group if, for strain A/H3N2, the lower limit of the 95% CI of the difference in the percentages is greater than -10%) |
| Non-inferiority testing in immune response (HI titer ≥40) of cTIV to that of TIV vaccine for strain B after one vaccination in adults. | Group difference | 0 | 2-Sided | 95 | -3 | 3 | Yes | Non-Inferiority or Equivalence | The percentage of subjects with HI titer ≥40 in the cTIV group is >10% lower than in the TIV group (i.e., the percentage of subjects with HI titer ≥40 in the cTIV group is non-inferior to that of TIV group if, for strain B, the lower limit of the 95% CI of the difference in the percentages is greater than -10%) |
| Non-inferiority testing in immune response (HI titer ≥40) of cTIV to that of TIV vaccine for strain A/H1N1 after one vaccination in the elderly population. | Group difference | -1 | 2-Sided | 95 | -4 | 3 | Yes | Non-Inferiority or Equivalence | The percentage of subjects with HI titer ≥40 in the cTIV group is >10% lower than in the TIV group (i.e., the percentage of subjects with HI titer ≥40 in the cTIV group is non-inferior to that of TIV group if, for strain A/H1N1, the lower limit of the 95% CI of the difference in the percentages is greater than -10%) |
| Non-inferiority testing in immune response (HI titer ≥40) of cTIV to that of TIV vaccine for strain A/H3N2 after one vaccination in the elderly population. | Group difference | -1 | 2-Sided | 95 | -2 | 1 | Yes | Non-Inferiority or Equivalence | The percentage of subjects with HI titer ≥40 in the cTIV group is >10% lower than in the TIV group (i.e., the percentage of subjects with HI titer ≥40 in the cTIV group is non-inferior to that of TIV group if, for strain A/H3N2, the lower limit of the 95% CI of the difference in the percentages is greater than -10%) |
| Non-inferiority testing in immune response (HI titer ≥40) of cTIV to that of TIV vaccine for strain B after one vaccination in the elderly population. | Group difference | 1 | 2-Sided | 95 | -2 | 4 | Yes | Non-Inferiority or Equivalence | The percentage of subjects with HI titer ≥40 in the cTIV group is >10% lower than in the TIV group (i.e., the percentage of subjects with HI titer ≥40 in the cTIV group is non-inferior to that of TIV group if, for strain B, the lower limit of the 95% CI of the difference in the percentages is greater than -10%) |
| OG003 | TIV (Elderly) | Subjects ≥61 years of age who received one vaccination of egg-derived influenza virus vaccine (TIV) |
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| TIV (Elderly) |
Subjects ≥61 years of age who received one vaccination of egg-derived influenza virus vaccine (TIV) |
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