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

Sponsors

Lead Sponsor: ALK-Abelló A/S

Source 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

Overall Status Completed
Start Date November 2006
Completion Date November 2007
Primary Completion Date September 2007
Phase Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
Hayfever symptoms Grass pollen season 2007
Intake of hayfever symptom relieving medication Grass pollen season 2007
Secondary Outcome
Measure Time Frame
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
Enrollment 253
Condition
Intervention

Intervention Type: Biological

Intervention Name: Grazax-R

Description: Grass tablet, 75.000 SQ per day for one year

Arm Group Label: 1

Intervention Type: Biological

Intervention Name: Grazax Placebo

Description: Grazax Placebo, 0 SQ tablet per day for one year

Arm Group Label: 2

Eligibility

Criteria:

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

Gender: All

Minimum Age: 5 Years

Maximum Age: 16 Years

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Friedrich Kaiser, Dr. med. Principal Investigator Tangstedter Landstrasse 77, 22415 Hamburg, Germany
Location
Facility: Tangstedter Landstrasse 77
Location Countries

Germany

Verification Date

March 2009

Has Expanded Access No
Number Of Arms 2
Arm Group

Label: 1

Type: Experimental

Description: Grazax treatment

Label: 2

Type: Placebo Comparator

Description: Grazax Placebo

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Source: ClinicalTrials.gov