Skip to main content
OpenTrials
Completed

NCT Number: NCT00408616

Efficacy and Safety of Grazax in Children

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Allergy Hypersensitivity Immune System Diseases

Age range

5 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Tangstedter Landstrasse 77

Hamburg, 22415, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Grazax-R

Biological

Grass tablet, 75.000 SQ per day for one year

Grazax Placebo

Biological

Grazax Placebo, 0 SQ tablet per day for one year

Primary outcomes

  1. Hayfever symptoms

    Time frame: Grass pollen season 2007

  2. Intake of hayfever symptom relieving medication

    Time frame: Grass pollen season 2007

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

ALK-Abelló A/S

Industry

Registry information

Official study 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

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Dec 7, 2006
Registry last updated
Mar 9, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.