Tolerability of Grazax-R in Children

NCT ID: NCT00298701

Last Updated: 2006-05-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-02-28

Study Completion Date

2006-04-30

Brief Summary

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

Detailed Description

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Conditions

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Allergy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

DOUBLE

Interventions

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ALK Grass tablet

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Minimum Eligible Age

5 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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ALK-Abelló A/S

INDUSTRY

Sponsor Role lead

Principal Investigators

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Kim Simonsen, MD

Role: STUDY_DIRECTOR

ALK-Abelló A/S

Locations

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Tangstedter Landstrasse 77

Hamburg, , Germany

Site Status

Countries

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Germany

Other Identifiers

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GT-11

Identifier Type: -

Identifier Source: org_study_id