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

NCT00554983 Phase 3 COMPLETED

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

Details

Lead sponsor	Allergopharma GmbH & Co. KG
Phase	Phase 3
Status	COMPLETED
Enrolment	255
Start date	2007-09
Completion	2012-05

Conditions

• Allergy

Interventions

• recombinant birch pollen allergen
• placebo

Primary outcomes

• Symptom-Medication-Score — during pollen season

Countries

Germany