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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Page 1 of 1 (1 locations)

1

Tangstedter Landstrasse 77

Hamburg, Germany, 22415