Efficacy and Safety of Grazax in Children

March 6, 2009 updated by: ALK-Abelló A/S

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

253

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Hamburg, Germany, 22415
        • Tangstedter Landstrasse 77

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 16 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Hayfever symptoms
Time Frame: Grass pollen season 2007
Grass pollen season 2007
Intake of hayfever symptom relieving medication
Time Frame: Grass pollen season 2007
Grass pollen season 2007

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ALK-Abelló A/S

Investigators

  • Principal Investigator: Friedrich Kaiser, Dr. med., Tangstedter Landstrasse 77, 22415 Hamburg, Germany

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2006

Primary Completion (Actual)

September 1, 2007

Study Completion (Actual)

November 1, 2007

Study Registration Dates

First Submitted

December 6, 2006

First Submitted That Met QC Criteria

December 6, 2006

First Posted (Estimate)

December 7, 2006

Study Record Updates

Last Update Posted (Estimate)

March 9, 2009

Last Update Submitted That Met QC Criteria

March 6, 2009

Last Verified

March 1, 2009

More Information

Terms related to this study

Other Study ID Numbers

  • GT-12

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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