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Influenza (flu) viruses change continuously, therefore also the parts of viruses used in influenza vaccines can vary from year to year. The current study is a phase III A clinical trial with a commercially available vaccine (Influvac®) supplied in pre filled syringes. The objective of this study is to investigate the immunogenicity and safety and tolerability of the changed influenza vaccine virus composition in two groups of subjects in good health: subjects aged >= 18 and <= 60 years and subjects >= 61 years of age (elderly).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Trivalent influenza subunit vaccine Influvac. "3x 15mcg Hemagglutinin Antigen (HA) per 0.5 ml,trivalent one injection at Day 1 " |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Trivalent influenza subunit vaccine Influvac | Biological | "3x 15mcg HA per 0.5 ml,trivalent one injection at Day 1 " |
|
| Measure | Description | Time Frame |
|---|---|---|
| the Serum Antihemagglutinin Antibody Titers and the Derived Parameters Defined in the Committee for Medicinal Products for Human Use (CHMP) Note for Guidance on Harmonization of Requirements for Influenza Vaccines for Influenza Vaccines. | Seroprotection and Seroconversion Rate for A/H1N1, A/H3N2, and B Strains 3 weeks After Vaccination in non-elderly adults and elderly adults. | 3 weeks post vaccination |
| the Serum Antihemagglutinin Antibody Titers and the Derived Parameters Defined in the Committee for Medicinal Products for Human Use (CHMP) Note for Guidance on Harmonization of Requirements for Influenza Vaccines for Influenza Vaccines. | Mean fold increase in HI antibody titer 3 weeks After Vaccination in non-elderly adults and elderly adults. | 3 weeks post vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Safety (Unsolicited Adverse Events) and Tolerability (Reactogenicity and Overall Inconvenience) of Influvac®. | up to 3 weeks post vaccination |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Facility ID ORG-001075 | Maroubra | NSW 2035 | Australia |
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| ID | Title | Description |
|---|---|---|
| FG000 | Influvac | Trivalent influenza subunit vaccine Influvac. "3x 15mcg Hemagglutinin Antigen (HA) per 0.5 ml,trivalent one injection at Day 1 " |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Influvac | Trivalent influenza subunit vaccine Influvac. "3x 15mcg HA per 0.5 ml,trivalent one injection at Day 1 " |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of 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 Serum Antihemagglutinin Antibody Titers and the Derived Parameters Defined in the Committee for Medicinal Products for Human Use (CHMP) Note for Guidance on Harmonization of Requirements for Influenza Vaccines for Influenza Vaccines. | Seroprotection and Seroconversion Rate for A/H1N1, A/H3N2, and B Strains 3 weeks After Vaccination in non-elderly adults and elderly adults. | Two subjects were excluded from the efficacy sample due to major protocol violations with a potential effect on immunogenicity outcome. | Posted | Number | 95% Confidence Interval | percentage of subjects | 3 weeks post vaccination |
|
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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 | Influvac | Trivalent influenza subunit vaccine Influvac. "3x 15mcg HA per 0.5 ml,trivalent one injection at Day 1 " |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| vaccine site pain | General disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Clinical Director | Abbott | +31294477184 | serge.vandewitte@abbott.com |
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| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
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| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Gender | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Primary | the Serum Antihemagglutinin Antibody Titers and the Derived Parameters Defined in the Committee for Medicinal Products for Human Use (CHMP) Note for Guidance on Harmonization of Requirements for Influenza Vaccines for Influenza Vaccines. | Mean fold increase in HI antibody titer 3 weeks After Vaccination in non-elderly adults and elderly adults. | Two subjects were excluded from the efficacy sample due to major protocol violations with a potential effect on immunogenicity outcome. | Posted | Mean | 95% Confidence Interval | fold change | 3 weeks post vaccination |
|
|
|
| Secondary | Safety (Unsolicited Adverse Events) and Tolerability (Reactogenicity and Overall Inconvenience) of Influvac®. | Posted | Number | participants | up to 3 weeks post vaccination |
|
|
|
| 0 |
| 120 |
| 19 |
| 120 |
| nasal congestion | Respiratory, thoracic and mediastinal disorders |
|
| oropharyngeal pain | Respiratory, thoracic and mediastinal disorders |
|
| application site pruritus | General disorders |
|
| cough | Respiratory, thoracic and mediastinal disorders |
|
| fatigue | General disorders |
|
| malaise | General disorders |
|
| vaccination site warmth | General disorders |
|
| nasopharyngitis | Respiratory, thoracic and mediastinal disorders |
|
| respiratory disorder | Respiratory, thoracic and mediastinal disorders |
|
| vomiting | Gastrointestinal disorders |
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| Hyperhidrosis | Skin and subcutaneous tissue disorders |
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| headache | Nervous system disorders |
|
| respiratory tract infection | Respiratory, thoracic and mediastinal disorders |
|
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| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |
|
| Mean fold increase A/H3N2 titer in elderly |
|
| Mean fold increase A/H1N1 titer in elderly |
|
| Mean fold increase B titer in elderly |
|