SUBLIVAC FIX Birch Dose Tolerability/Dose Range Finding

Inclusion Criteria: * Signed informed consent * Age ≥ 18 ≤ 60 years * Allergic rhinitis/rhinoconjunctivitis related to birch pollen with or without concomitant mild to moderate persistent asthma * FEV1 \> 70% for patients with a history of asthma, FEV \> 70% or PEF \> 80% for patients without a history of asthma * A positive SPT (mean wheal diameter ≥ 3mm compared to negative control and negative control should be negative) for birch pollen assessed within 1 year before randomization. * Positive serum specific anti-birch IgE-test (\> 0.7 U/mL) * A positive TNPT for birch pollen at screening (Lebel score ≥ 6) at * 10,000 AU/mL Exclusion Criteria: * Patients with (expected) clinically relevant symptoms during the course of the trial due to concomitant sensitization i.e. positive SPT (mean wheal diameter ≥ 3mm) to allergens other than birch pollen * Patients sensitized to pets should not be included if they are regularly exposed to pets and are symptomatic upon exposure to pets * Completed immunotherapy (SCIT or SLIT) with birch pollen allergens within the past 5 years * Completed unsuccessful specific immunotherapy in the past * Vaccination within one week before start of therapy or during the initiation phase * Anti-IgE therapy within the 6 months prior to inclusion and during the study * Severe immune disorders (including auto-immune diseases) and/or diseases requiring immunosuppressive drugs * Active malignancies or any malignant disease during the previous 5 years …