Tolerability of Grazax-R 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: NCT00298701
Recruitment Status : Completed
First Posted : March 3, 2006
Last Update Posted : May 4, 2006
Information provided by:
ALK-Abelló A/S

Brief Summary:
This trial is performed to assess whether the Grazax-R treatment is safe to use in children aged 5-12 years.

Condition or disease Intervention/treatment Phase
Allergy Biological: ALK Grass tablet Phase 1

Study Type : Interventional  (Clinical Trial)
Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Official Title: A Randomised, Double-Blind, Placebo-Controlled, Multi-Centre Phase I Trial Investigating the Safety of GRAZAX-R in Children Aged 5-12 Years With Grass Pollen Induced Rhinoconjunctivitis (With/Without Asthma)
Study Start Date : February 2006
Study Completion Date : April 2006

Primary Outcome Measures :
  1. Assessment of safety by recording of adverse events

Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Grass pollen induced rhinoconjunctivitis
  • Boys and girls, 5-12 years of age
  • Positive skin prick test to grass pollen

Exclusion Criteria:

  • Previous treatment with immunotherapy

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): NCT00298701

Tangstedter Landstrasse 77
Hamburg, Germany, 22415
Sponsors and Collaborators
ALK-Abelló A/S
Study Director: Kim Simonsen, MD ALK-Abelló A/S Identifier: NCT00298701     History of Changes
Other Study ID Numbers: GT-11
First Posted: March 3, 2006    Key Record Dates
Last Update Posted: May 4, 2006
Last Verified: May 2006

Keywords provided by ALK-Abelló A/S: