An interventional trial assessing the tolerability and safety of GRAZAX® in adults with grass pollen allergy

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2009-014522-41-DE

Enrollment

100

Registered

2009-10-21

Start date

2010-01-26

Completion date

Unknown

Last updated

2013-11-26

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

Conditions

Grass pollen induced rhinoconjunctivitis MedDRA version: 12.0 Level: LLT Classification code 10001728 Term: Allergic rhinoconjunctivitis

Interventions

Trade Name: GRAZAX® Pharmaceutical Form: Oral lyophilisate Current Sponsor code: GRAZAX® Concentration unit: SQU Standardised Quality Unit(s) (Deprecated) Concentration type: equal Concentration num

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients who meet each of the following criteria are eligible for the trial: 1. Written informed consent obtained before entering the trial 2. Willing and able to comply with the trial protocol regimen 3. Participated in the GT-08 extension trial and received placebo treatment 4. Will be prescribed Grazax in line with approved SmPC. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Patients who meet one or more of the following criteria are excluded from the trial: 1. History of allergy, hypersensitivity or intolerance to any of the excipients (except Phleum pratense) 2. Malignancy or systemic diseases affecting the immune system e.g. autoimmune diseases, immune complex diseases or immune deficiency diseases 3. Alcohol or drug abuse 4. Immunosuppressive treatment 5. Inflammatory conditions in the oral cavity with severe symptoms such as oral lichen planus with ulcerations or severe oral mycosis 6. Uncontrolled or severe asthma (FEV1 < 70% of predicted value after adequate pharmacologic treatment) 7. Pregnancy 8. Conditions or diseases which are contraindicated or otherwise not in line with the approved Grazax SmPC 9. Simultaneously participating in a different trial including a treatment intervention and/or an investigational medicinal product (IMP).

Design outcomes

Primary

Measure	Time frame
Main Objective: to investigate the safety and tolerability of Grazax;Secondary Objective: to evaluate the patients’ satisfaction with Grazax;Primary end point(s): To investigate the safety and tolerability of Grazax	—

Countries

Austria, Denmark, Germany

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026