Allergy
Conditions
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 season
Interventions
BIOLOGICALGrazax-R
Grass tablet, 75.000 SQ per day for one year
BIOLOGICALGrazax Placebo
Grazax Placebo, 0 SQ tablet per day for one year
Sponsors
ALK-Abelló A/S
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
5 Years to 16 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hayfever symptoms | Grass pollen season 2007 |
| Intake of hayfever symptom relieving medication | Grass pollen season 2007 |
Secondary
| Measure | Time frame |
|---|---|
| Global Evaluation of treatment efficacy | Grass pollen season 2007 |
| Adverse Events | 9 months |
| Combined hayfever symptom and medication scores | Grass pollen season 2007 |
| Immunological Assessment | 9 months |
| Pharmacoeconomic Assessment | 9 months |
| Asthma symptoms and medication | Grass pollen season 2007 |
Countries
Germany
Outcome results
None listed