A multicenter, randomized, open-label clinical trial to evaluate safety and tolerability of a year-round initiation of specific immunotherapy with an aluminum hydroxide adsorbed allergoid preparation of 6-grasses in patients with moderate to severe seasonal rhinitis or rhinoconjunctivitis with or without controlled asthma.

INTERVENTION: Trade Name: Allergovit® Grasses Product Name: Allergovit® Grasses Product Code: 553a/91a‐b Pharmaceutical Form: Suspension for injection INN or Proposed INN: Allergovit® grasses CAS Number: 8000045‐25‐2 Other descriptive name: ALLERGENS, POLLEN & PLANT EXTRACT Concentration unit: U/ml unit(s)/millilitre Concentration type: range Concentration number: 100‐6000 CONDITION: Patients with moderate to severe seasonal rhinitis or rhinoconjunctivitis with or without controlled asthma. ; MedDRA version: 19.0 Level: LLT Classification code 10039776 Term: Seasonal allergic rhinitis System Organ Class: 100000004870 ; MedDRA version: 19.0 Level: LLT Classification code 10001726 Term: Allergic rhinitis due to pollen System Organ Class: 100000004870 ; MedDRA version: 19.0 Level: LLT Classification code 10001728 Term: Allergic rhinoconjunctivitis System Organ Class: 100000004853 ; MedDRA version: 19.0 Level: LLT Classification code 10001705 Term: Allergic asthma System Organ Class: 100000004855 ; MedDRA version: 19.0 Level: LLT Classification code 10001723 Term: Allergic rhinitis System Organ Class: 100000004855 Therapeutic area: Diseases [C] ‐ Respiratory Tract Diseases [C08] SECONDARY OUTCOME: Secondary end point(s): Not applicable. Timepoint(s) of evaluation of this end point: Not applicable. INCLUSION CRITERIA: 1. Written informed consent given according to local requirements before any trial‐related activities started (a trial‐related activity is any procedure that would not have been performed during the routine management of the patient). 2. Legally competent male or female outpatient 3. Age = 18 and = 65 years 4. IgE‐mediated seasonal allergic rhinitis or rhinoconjunctivitis with or without controlled allergic asthma caused by grass pollen as confirmed by the following test procedures: • Skin prick test (SPT): • wheal for 6‐grasses pollens = 3 mm in diameter • Histamine wheal = 3 mm (positive control) • NaCl reaction < 2 mm (negative control) • Immunoassay result for specific IgE = 0.70 kU/L to grass mix/earlybloom (central lab) 5. Main symptoms of allergic rhinitis or rhinoconjunctivitis between the months of May to August of at least 1 month with respective grass pollen exposure in the previous 2 seasons 6. Previous treatm PRIMARY OUTCOME: Main Objective: The main objective of this therapeutic phase IIIb trial is to evaluate the safety and tolerability of a year‐round initiation start of immunotherapy with Allergovit® 6‐grasses in patients with rhinitis or rhinoconjunctivitis, caused by grasses, with or without controlled allergic asthma compared to a standard therapy.; A possible influence (masking of adverse events) of a symptomatic co‐medication during intraseasonal therapy will be considered. Primary end point(s): The aim of the trial is to obtain information about the safety and tolerability of an intraseasonal compared to a standard dose escalation of Allergovit® 6‐grasses.; To achieve this goal, the following safety variables will be assessed:; • the incidence, type and intensity of AEs and serious adverse events (SAE) according to MedDRA primary system organ class (SOC) and preferred term,; • the incidence, type and intensitiy of AEs assessed as drug related (by investigator) according to MedDRA primary system organ class (SOC) and preferred term,; • the incidence, type and intensity of local AEs assessed as drug related (by investigator) according to MedDRA primary system organ class (SOC) and preferred term,; • the incidence and intensity of anaphylactic reactions after injections according to the World Allergy Organization (WAO) grading system,; • the use of anti‐symptomatic co‐therapy; • the change of laboratory values (hematology, clinical chemistry and urinalysis) measured before and after the treatment phase, ; • the change of vital signs, ; • the change of PEF from patients, measured before, during and after treatment,; • an assessment of the overall tolerability by the investigator and the patient using a 5 point Likert scale.; ; Exploratory immunological parameters will be evaluated at Screening (S1) and Final Visit (FV):; • Specific IgG4 for Phleum pratense.; Secondary Objective: Not applicable. Timepoint(s) of evaluation of this end point: After database lock, approximatly April 2017.