Efficacy and Safety of Grazax in Children

ALK-Abelló A/S253 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

253

Conditions

Allergy

Interventions

Grazax-RBIOLOGICAL

Grass tablet, 75.000 SQ per day for one year

Grazax PlaceboBIOLOGICAL

Grazax Placebo, 0 SQ tablet per day for one year

Eligibility

Sex: ALLMin age: 5 YearsMax age: 16 Years

Medical Language ↔ Plain English

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

Locations (1)

Tangstedter Landstrasse 77

Hamburg, Germany