Twin SUBLIVAC® Grasses Clinical Efficacy Study

Inclusion Criteria:

• Subjects with allergic rhinoconjunctivitis with or without mild asthma FEV1 ≥ 70%) forat least 2 years. Their allergic symptoms should be related to grass pollen Use ofanti-allergy symptomatic medication in the last pollen season (or, in case of a lowpollen season, in one of the two previous years)

• A positive skin prick test (>3 mm) for early flowering treesgrasses and specific serumIgE-test(>1 U/ml) for grass pollen (Lolium perenne, Phleum pratense and Poapratensis).

Exclusion Criteria:

• A positive SPT for perennial allergens of house dust mite

• Allergy to any of the excipients

• Symptoms related to concomitant sensitisation to perennial allergens of pets

• Chronic asthma or emphysema, particularly with a FEV1 < 70 % of predicted value or useof inhalation corticosteroids outside grass and tree pollen season for more than twoepisodes and/or longer than fourteen days

• Use of symptomatic medication for more than three episodes and/or longer than threedays outside the tree- or grass pollen season

• Serious immuno-pathological diseases or malignancies (including auto-immune diseases,tuberculosis, HIV)

• Inflammation and infection of the target organ

• Severe atopic dermatitis requiring systemic immuno-suppressive medication

• Allergen specific immuno-therapy treatment within the last 5 years for a period longerthan three months

• History of life threatening anaphylactic events, including anaphylactic food allergy,insect venom anaphylaxis, exercise or drug induced anaphylaxis

• A positive pregnancy test, lactation or inadequate contraceptive measures Alcohol- ordrug abuse

• Lack of co-operation or severe psychological disorders