Tolerability of ALK Grass Tablet in Children

A Randomised, Double-Blind, Placebo-Controlled, Multi-Centre Phase I Trial Investigating the Safety of ALK Grass Tablet 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

NCT00310453

Enrollment

Registered

2006-04-04

Start date

2006-03-31

Completion date

2006-05-31

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

Brief summary

The purpose of this trial is to assess whether the ALK Grass tablet 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

* Severe asthma * Previous treatment with immunotherapy

Design outcomes

Primary

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

Countries

Spain

Outcome results

None listed

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