Efficacy and Safety of Grazax in Children

A Phase III Trial Investigating the Efficacy and Safety of Grazax in Children Aged 5-16 Years With Grass Pollen Induced Rhinoconjunctivitis With or Without Asthma

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

Inclusion Criteria:

• 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 Criteria:

• 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