SUBLIVAC FIX Birch Phase III Short-term Efficacy

Inclusion Criteria: * Signed informed consent * Age ≥ 18 and ≤65 years * Moderate-to-severe birch pollen induced allergic rhinitis/rhinoconjunctivitis based on ARIA classification for at least 2 consecutive years * FEV1 (forced expiratory volume at one second) \> 70% (of predicted value) for patients with a history of asthma, FEV1 \> 70% or PEF (peak expiratory flow) \> 80% (of predicted value) for patients without a history of asthma * Positive SPT (skin prick test) for birch pollen (mean wheal diameter ≥ 3mm compared to negative control; negative control should be negative; histamine control should be positive (mean wheal diameter ≥ 3mm)) assessed during screening. * Serum specific anti-birch IgE (immunoglobulin E) concentration \>0.7 U/ml * Patients should be willing and capable to complete an e-diary daily during the birch pollen season (≥ 60% compliance in completion between Visit 1 and 2). * A positive Nasal Provocation Test to birch pollen at Visit 2 (Lebel score ≥ 6) or a documented positive test within 1 year before start of treatment Exclusion Criteria: * Patients sensitized and symptomatic to pets should not be included if they are regularly exposed to pets * Specific immunotherapy (SCIT or SLIT) with birch pollen or a cross-reacting allergen within the last 5 years * SPT positive (mean wheal diameter ≥ 3mm compared to negative control; negative control should be negative; histamine control should be positive (mean wheal diameter ≥ 3mm)) patients to allergen(s) …