Efficacy and Safety of Grazax in Children

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00408616
Recruitment Status : Completed
First Posted : December 7, 2006
Last Update Posted : March 9, 2009
Information provided by:
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

Condition or disease Intervention/treatment Phase
Allergy Biological: Grazax-R Biological: Grazax Placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 253 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : November 2006
Actual Primary Completion Date : September 2007
Actual Study Completion Date : November 2007

Arm Intervention/treatment
Experimental: 1
Grazax treatment
Biological: Grazax-R
Grass tablet, 75.000 SQ per day for one year

Placebo Comparator: 2
Grazax Placebo
Biological: Grazax Placebo
Grazax Placebo, 0 SQ tablet per day for one year

Primary Outcome Measures :
  1. Hayfever symptoms [ Time Frame: Grass pollen season 2007 ]
  2. Intake of hayfever symptom relieving medication [ Time Frame: Grass pollen season 2007 ]

Secondary Outcome Measures :
  1. Combined hayfever symptom and medication scores [ Time Frame: Grass pollen season 2007 ]
  2. Asthma symptoms and medication [ Time Frame: Grass pollen season 2007 ]
  3. Global Evaluation of treatment efficacy [ Time Frame: Grass pollen season 2007 ]
  4. Adverse Events [ Time Frame: 9 months ]
  5. Pharmacoeconomic Assessment [ Time Frame: 9 months ]
  6. Immunological Assessment [ Time Frame: 9 months ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   5 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00408616

Tangstedter Landstrasse 77
Hamburg, Germany, 22415
Sponsors and Collaborators
ALK-Abelló A/S
Principal Investigator: Friedrich Kaiser, Dr. med. Tangstedter Landstrasse 77, 22415 Hamburg, Germany