Efficacy and Safety From a Recombinant Folding Variant of Bet v 1

Phase 3

Completed

• Conditions: Allergy
• Interventions: Biological: placebo; Biological: recombinant birch pollen allergen

• Registration Number: NCT00554983
• Lead Sponsor: Allergopharma GmbH & Co. KG

Brief Summary

Efficacy and Safety from a recombinant folding variant of Bet v 1

Detailed Description

Not available

Study Timeline

• Study Start: 2007-09
• Study First Submitted: 2007-11-06
• Study First Submitted QC: 2007-11-06
• Study First Posted: 2007-11-07
• Primary Completion: 2010-06
• Study Completion: 2012-05
• Status Verified: 2013-11
• Last Update Submitted: 2013-11-07
• Last Update Posted: 2013-11-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 255

Inclusion Criteria

• Allergic rhinoconjunctivitis attributable to birch pollen
• Positive SPT
• Positive EAST
• Positive specific provocation test

Exclusion Criteria

• Serious chronic diseases
• Other perennial allergies

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	placebo	-
1	recombinant birch pollen allergen	-

Primary Outcome Measures

Name	Time	Method
Symptom-Medication-Score	during pollen season

Trial Locations

Locations (1)

Allergopharma GmbH & Co. KG; 🇩🇪 Reinbek, Germany