A phase III trial investigating the efficacy and safety of Grazax in children aged 5-16 years with grass pollen induced rhinoconjunctivitis with or without asthma

INTERVENTION: Product Name: GRAZAX Product Code: ALK Grass tablet Pharmaceutical Form: Oral lyophilisate Pharmaceutical form of the placebo: Soluble tablet Route of administration of the placebo: Sublingual use CONDITION: IgE Mediated allergy (hay fever, rhinoconjunctivitis) to grass pollen (Timothy grass, Phleum pratense) with or without asthma PRIMARY OUTCOME: Main Objective: To evaluate the efficacy and safety of specific immunotherapy with Grazax compared to placebo, in children with grass pollen induced allergic rhinoconjunctivitis. Primary end point(s): Secondary Objective: • To investigate the efficacy and safety of Grazax based on the following information:; ? Rhinoconjunctivitis symptom and medication scores in the peak grass pollen season; ? Asthma symptom and medication score in the grass pollen season; ? Asthma symptom and medication score in the peak grass pollen season; ? Pharmacoeconomic data in the grass pollen season; ? Safety Assessments at screening and End of treatment; INCLUSION CRITERIA: • To investigate the efficacy and safety of Grazax based on the following information: ? Rhinoconjunctivitis symptom and medication scores in the peak grass pollen season ? Asthma symptom and medication score in the grass pollen season ? Asthma symptom and medication score in the peak grass pollen season ? Pharmacoeconomic data in the grass pollen season ? Safety Assessments at screening and End of treatment Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18‐64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range