Efficacy and Safety of Grazax in Children

Phase 3

Completed

• Conditions: Allergy

• Registration Number: NCT00408616
• Lead Sponsor: ALK-Abelló A/S

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

Detailed Description

Not available

Study Timeline

• Study Start: 2006-11
• Study First Submitted: 2006-12-06
• Study First Submitted QC: 2006-12-06
• Study First Posted: 2006-12-07
• Primary Completion: 2007-09
• Study Completion: 2007-11
• Status Verified: 2009-03
• Last Update Submitted: 2009-03-06
• Last Update Posted: 2009-03-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 253

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Hayfever symptoms	Grass pollen season 2007
Intake of hayfever symptom relieving medication	Grass pollen season 2007

Secondary Outcome Measures

Name	Time	Method
Combined hayfever symptom and medication scores	Grass pollen season 2007
Asthma symptoms and medication	Grass pollen season 2007
Global Evaluation of treatment efficacy	Grass pollen season 2007
Adverse Events	9 months
Pharmacoeconomic Assessment	9 months
Immunological Assessment	9 months

Trial Locations

Locations (1)

Tangstedter Landstrasse 77; 🇩🇪 Hamburg, Germany