Tolerability of Grazax-R in Children

A Randomised, Double-Blind, Placebo-Controlled, Multi-Centre Phase I Trial Investigating the Safety of GRAZAX-R in Children Aged 5-12 Years With Grass Pollen Induced Rhinoconjunctivitis (With/Without Asthma)

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00298701

Enrollment

Registered

2006-03-03

Start date

2006-02-28

Completion date

2006-04-30

Last updated

2006-05-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Allergy

Keywords

Allergy

Brief summary

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

Interventions

BIOLOGICALALK Grass tablet

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

5 Years to 12 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Assessment of safety by recording of adverse events	—

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026