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This is a comparative vaccination study of the reactogenicity and immunogenicity of a thiomersal-free formulation of Influsplit SSW® 2002/2003 versus the standard formulation of Influsplit SSW® 2002/2003 in individuals over 18 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Experimental | The subjects in this group will be 18-60 years. |
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| Group B | Experimental | The subjects in this group will be > 60 years. |
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| Group C | Active Comparator | The subjects in this group will be 18-60 years. |
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| Group D | Active Comparator | The subjects in this group will be > 60 years. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Thiomersal free trivalent influenza split vaccine 2002/2003 | Biological | Single dose, intramuscular injection |
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| Measure | Description | Time Frame |
|---|---|---|
| GMT of the haemagglutination-inhibiting antibodies (HIA) and calculation of seroconversion factor, seroconversion rate and seroprotection rate checked against the CHMP criteria. The seroprotection power will be calculated as well. | On Day 21 (± 2) after vaccination | |
| Descriptive comparison of the occurrence, severity and causal relationship to vaccination of solicited local and general symptoms | Within 4 days after vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Descriptive comparison of the occurrence and causal relationship to vaccination of unsolicited signs and symptoms | Within 30 days after vaccination | |
| Descriptive comparison of the occurrence, severity and causal relationship to vaccination of any serious adverse events (SAEs) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Clinical Trials Call Center | Dresden | Germany |
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| GlaxoSmithKline Biologicals' Influsplit SSW®/Fluarix™ 2002/2003 | Biological | Single dose, intramuscular injection |
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| During the entire study period. |
| Investigation of antibody persistence assessed by the criteria of the CHMP. | 11, 19, 27 weeks after vaccination |
| 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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