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

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

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

Inclusion Criteria:

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

Exclusion Criteria:

• Serious chronic diseases
• Other perennial allergies