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The aim of the present study is to assess the reactogenicity and immunogenicity of a thiomersal-free influenza vaccine. For comparison, a group of subjects is administered the standard formulation of Influsplit SSW® 2003/2004.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Experimental | Subjects aged between 6 months and 3 years. |
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| Group B | Experimental | Subjects aged 3 to 6 years. |
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| Group C | Active Comparator | Subjects aged between 6 months and 3 years. |
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| Group D | Active Comparator | Subjects aged 3 to 6 years. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Thiomersal free trivalent influenza split vaccine 2003/2004 | Biological | 2 doses, intramuscular injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| GMT of the haemagglutination-inhibiting (HI) antibodies and calculation of seroconversion factor, seroconversion rate & seroprotection rate, checked against CHMP criteria (for 18 - 60 years old); seroprotection power is also calculated. | On Day 21 (+- 2) after the second vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Descriptive comparison of the occurrence and severity of solicited local and general symptoms | Within 4 days after each vaccination | |
| Descriptive comparison of the occurrence, severity and relationship to vaccination of unsolicited signs and symptoms | Within 30 days after each vaccination |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Bützow | Mecklenburg-Vorpommern | 18246 | Germany | ||
| GSK Investigational Site |
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| Label | URL |
|---|---|
| Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research. | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| 100351 | Study Protocol | View IPD |
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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| GlaxoSmithKline Biologicals' Influsplit SSW®/Fluarix™ 2003/2004 | Biological | 2 doses, intramuscular injection |
|
|
| Descriptive comparison of the occurrence, severity and relationship to vaccination of serious adverse events (SAEs). | Throughout the study |
| GMT of the HI antibodies in each case against the 3 influenza virus strains of the vaccine separately for both age groups. | On Day 21 (+- 2), Month 3 and Month 6 after the second vaccination |
| Rostock |
| Mecklenburg-Vorpommern |
| 18106 |
| Germany |
| GSK Investigational Site | Bischofswerda | Saxony | 01877 | Germany |
| GSK Investigational Site | Coswig | Saxony | 01640 | Germany |
| GSK Investigational Site | Dresden | Saxony | 01169 | Germany |
| GSK Investigational Site | Dresden | Saxony | 01307 | Germany |
| GSK Investigational Site | Leipzig | Saxony | 04209 | Germany |
| GSK Investigational Site | Bad Segeberg | Schleswig-Holstein | 23795 | Germany |
| GSK Investigational Site | Flensburg | Schleswig-Holstein | 24937 | Germany |
| GSK Investigational Site | Husum | Schleswig-Holstein | 25813 | Germany |
| GSK Investigational Site | Berlin | State of Berlin | 10315 | Germany |
| GSK Investigational Site | Berlin | State of Berlin | 12627 | Germany |
| GSK Investigational Site | Berlin | State of Berlin | 13355 | Germany |
For additional information about this study please refer to the GSK Clinical Study Register |
| 100351 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 100351 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 100351 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 100351 | Annotated Case Report Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 100351 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 100351 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 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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