Status:
COMPLETED
Efficacy and Safety of Grazax in Children
Lead Sponsor:
ALK-Abelló A/S
Conditions:
Allergy
Eligibility:
All Genders
5-16 years
Phase:
PHASE3
Brief Summary
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 seas...
Eligibility Criteria
Inclusion
- Boys and girls 5-16 years of age
- A clinical history of grass pollen induced hayfever
- Positive Skin Prick Test to Phleum pratense
- Positive specific IgE against Phleum pratense
Exclusion
- History of seasonal hayfever symptoms (and/or asthma) caused by another allergen than Phleum pratense during or overlapping the grass pollen season
- History of perennial hayfever (and/or asthma) that needs medication due to an allergen to which the child is regularly exposed
- History of severe asthma
- Current severe atopic dermatitis
Key Trial Info
Start Date :
November 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2007
Estimated Enrollment :
253 Patients enrolled
Trial Details
Trial ID
NCT00408616
Start Date
November 1 2006
End Date
November 1 2007
Last Update
March 9 2009
Active Locations (1)
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1
Tangstedter Landstrasse 77
Hamburg, Germany, 22415