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CompletedNCT00298701Updated May 4, 2006

Tolerability of Grazax-R in Children

A Phase 1 interventional study of ALK Grass tablet in Allergy, sponsored by ALK-Abelló A/S. Completed at 1 site in Germany. Open to participants aged 5 Years to 12 Years. Per ClinicalTrials.gov, last updated 2006-05-04.

Sponsored by ALK-Abelló A/S · Phase 1 and Interventional

Phase
Phase 1
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
5 Years to 12 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Allergy

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Keywords

  • Allergy
03

In context

Hypersensitivity

1,916 studies on the registry are indexed under Hypersensitivity; 265 are open to participants now.

This study's enrollment of 50 is below the median of 57 across 1,384 interventional studies indexed under Hypersensitivity.

Browse Hypersensitivity studies →

Lead sponsor

ALK-Abelló A/S is the lead sponsor of 66 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
5 Years to 12 Years
Sexes eligible
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

Exclusion Criteria:

  • Previous treatment with immunotherapy
05

Study design

Phase
Phase 1
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double
Enrollment
50 participants

Interventions

  • BiologicalALK Grass tablet
06

What researchers measure

Primary outcomes

  1. Assessment of safety by recording of adverse events

07

Study locations

1 site
  • Tangstedter Landstrasse 77
    Hamburg, 22415, Germany
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 4, 2006, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00298701
Lead sponsor
ALK-Abelló A/S
First posted
Mar 3, 2006
Start date
Feb 2006
Completion
Apr 2006
Last update
May 4, 2006

Study contacts

Kim Simonsen, MD
study director · ALK-Abelló A/S
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2006. You cannot join it, but the record below documents what was studied.

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