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Tolerability of Grazax-R in Children

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00298701
First Posted: March 3, 2006
Last Update Posted: May 4, 2006
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.
Information provided by:
ALK-Abelló A/S
  Purpose
This trial is performed to assess whether the Grazax-R treatment is safe to use in children aged 5-12 years.

Condition Intervention Phase
Allergy Biological: ALK Grass tablet Phase 1

Study Type: Interventional
Study Design: 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)

Further study details as provided by ALK-Abelló A/S:

Primary Outcome Measures:
  • Assessment of safety by recording of adverse events

Estimated Enrollment: 50
Study Start Date: February 2006
Estimated Study Completion Date: April 2006
  Eligibility

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
Criteria

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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00298701


Locations
Germany
Tangstedter Landstrasse 77
Hamburg, Germany, 22415
Sponsors and Collaborators
ALK-Abelló A/S
Investigators
Study Director: Kim Simonsen, MD ALK-Abelló A/S
  More Information

ClinicalTrials.gov Identifier: NCT00298701     History of Changes
Other Study ID Numbers: GT-11
First Submitted: March 1, 2006
First Posted: March 3, 2006
Last Update Posted: May 4, 2006
Last Verified: May 2006

Keywords provided by ALK-Abelló A/S:
Allergy