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Efficacy and Safety of Grazax in Children

NCT00408616 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 253

Last updated 2009-03-09

No results posted yet for this study

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

Conditions

  • Allergy

Interventions

BIOLOGICAL

Grazax-R

Grass tablet, 75.000 SQ per day for one year

BIOLOGICAL

Grazax Placebo

Grazax Placebo, 0 SQ tablet per day for one year

Sponsors & Collaborators

  • ALK-Abelló A/S

    lead INDUSTRY

Principal Investigators

  • Friedrich Kaiser, Dr. med. · Tangstedter Landstrasse 77, 22415 Hamburg, Germany

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
5 Years
Max Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-11-30
Primary Completion
2007-09-30
Completion
2007-11-30

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00408616 on ClinicalTrials.gov