Efficacy and Safety of 300 IR Sublingual Immunotherapy (SLIT) Tablets in Children Suffering From Grass Pollen Rhinoconjunctivitis

A Randomised, Double-blind, Placebo-controlled, Multi-national, Multi-centre, Phase III Paediatric Study of the Efficacy and Safety of 300 IR Sublingual Immunotherapy (SLIT) Administered as Allergen-based Tablets Once Daily to Children Suffering From Grass Pollen Rhinoconjunctivitis

A phase III study to evaluate the efficacy and safety of SLIT for grass pollen allergens compared with placebo for reduction of symptoms and rescue medication usage in children.

Inclusion Criteria:

• Male or female outpatients aged 5 to 17 years.
• Written consent / assent.
• Grass pollen-related allergic rhinoconjunctivitis for at least the last two pollen seasons.
• Sensitised to grass pollen (positive SPT and grass pollen-specific IgE values of at least Class 2).
• Total symptom score on the Retrospective RTSS during the previous pollen season of greater than or equal to 12.

Exclusion Criteria:

• Patients who have received any desensitisation treatment for grass pollen.