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The purpose of this study is to investigate if immunotherapy with Grazax is safe and reduces the hayfever symptoms and the use of symptom relieving medications in children during the grass pollen season
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Grazax treatment |
|
| 2 | Placebo Comparator | Grazax Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Grazax-R | Biological | Grass tablet, 75.000 SQ per day for one year |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Hayfever symptoms | Grass pollen season 2007 | |
| Intake of hayfever symptom relieving medication | Grass pollen season 2007 |
| Measure | Description | Time Frame |
|---|---|---|
| Combined hayfever symptom and medication scores | Grass pollen season 2007 | |
| Asthma symptoms and medication | Grass pollen season 2007 | |
| Global Evaluation of treatment efficacy |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Friedrich Kaiser, Dr. med. | Tangstedter Landstrasse 77, 22415 Hamburg, Germany | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tangstedter Landstrasse 77 | Hamburg | 22415 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19130937 | Result | Bufe A, Eberle P, Franke-Beckmann E, Funck J, Kimmig M, Klimek L, Knecht R, Stephan V, Tholstrup B, Weisshaar C, Kaiser F. Safety and efficacy in children of an SQ-standardized grass allergen tablet for sublingual immunotherapy. J Allergy Clin Immunol. 2009 Jan;123(1):167-173.e7. doi: 10.1016/j.jaci.2008.10.044. |
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| ID | Term |
|---|---|
| D006967 | Hypersensitivity |
| ID | Term |
|---|---|
| D007154 | Immune System Diseases |
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| Grazax Placebo |
| Biological |
Grazax Placebo, 0 SQ tablet per day for one year |
|
| Grass pollen season 2007 |
| Adverse Events | 9 months |
| Pharmacoeconomic Assessment | 9 months |
| Immunological Assessment | 9 months |