Twin SUBLIVAC® Grasses Clinical Efficacy Study

• Status: Completed
• Trial end date: 2007-10-01
• Target enrollment: 0
• Participant gender: All

Summary

To show that treatment with SUBLIVAC® Grasses is clinically effective by means of reduction in allergic symptoms and/or use of allergic symptomatic medication in subjects suffering from IgE mediated allergic complaints triggered by grass pollen.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: HAL Allergy

Criteria

Inclusion Criteria:

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

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

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 use of inhalation corticosteroids outside grass and tree pollen season for more than two episodes and/or longer than fourteen days

• Use of symptomatic medication for more than three episodes and/or longer than three days 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 longer than 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- or drug abuse

• Lack of co-operation or severe psychological disorders