Safety and Efficacy of Recombinant Birch Pollen Allergen in the Treatment of Allergic Rhinoconjunctivitis

A Multicentre Randomised Placebo-controlled Double-blind Clinical Trial for Evaluation of Safety and Efficacy of Immunotherapy With an Aluminium Hydroxide-adsorbed Recombinant Hypoallergenic Derivative of the Major Birch Pollen Allergen, Bet v 1

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00309062

Enrollment

Unknown

Registered

2006-03-31

Start date

2003-12-31

Completion date

2009-06-30

Last updated

2013-03-11

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

Conditions

Birch Pollen Allergy

Keywords

Allergy, Birch pollen, Recombinant

Brief summary

Safety and efficacy of recombinant birch pollen allergen in the treatment of allergic rhinoconjunctivitis

Interventions

BIOLOGICALRecombinant birch pollen

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

Inclusion criteria

* Positive Skin Prick Test reaction to birch pollen * Positive RAST result to birch pollen * Positive Provocation Test result to birch pollen

Exclusion criteria

* Serious chronic diseases * Other perennial allergies

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 15, 2026