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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-001032-57 | EudraCT Number |
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Annual study to investigate influenza vaccine (flu vaccine) developed for the 2012/2013 season for the prevention of influenza infection. The immunizing effect is being investigated, as well as its tolerability and safety.
An open, baseline-controlled study in two age groups: adults and elderly. The subjects will be screened within 14 days prior to or at Visit 1 (Day 1). At Visit 1 (Day 1) subjects will be vaccinated after blood sampling for baseline serum antihemagglutinin antibody titration. Subjects will be asked to record local and systemic reactions daily on a diary at home for 72 hours after vaccination. One week later (Visit 2, Day 8) the subjects will return to the study site to hand in the diary and for the assessment of safety and tolerability (reactogenicity and overall inconvenience). Three weeks after vaccination (Visit 3, Day 22) the subjects will return to the study site for blood sampling to assess immunogenicity and for the assessment of safety and tolerability.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Trivalent influenza subunit vaccine Influvac | Experimental | 3x 15mcg 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 |
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| Measure | Description | Time Frame |
|---|---|---|
| Antihemagglutinin antibody titers and the derived parameters seroprotection, seroconversion and mean fold increase | Standard parameters to quantify antibody levels. Recommended in the CHMP guideline. | 3 weeks |
| Solicited local and systemic reactions, overall inconvenience | Reactogenicity and inconvenience | 3 days |
| Unsolicited adverse events | Other adverse events | 3 weeks |
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Inclusion Criteria
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Serge van de Witte, PhD | Abbott Healthcare Products BV | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site Reference ID/Investigator# 74593 | Hamburg | 22769 | Germany |
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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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| ID | Term |
|---|---|
| C568705 | influvac |
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| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |