Follow-up of Study AN004T to Assess the Persistence of AllerT Efficacy During the 2nd to 4th Season After Treatment

Long-term Follow-up of a Multicentre, Randomized, Double-blind, Placebo-controlled Trial (AN004T) Assessing the Efficacy and Tolerability of 2 Dosing Regimens of AllerT in Adult Subjects Allergic to Birch Pollen

Study aiming to evaluate the efficacy of a 2-month pre-seasonal treatment with an AllerT 50 µg or 100 µg maintenance dose administered in previous study AN004T in reducing symptoms of allergic rhinoconjunctivitis during the 2nd following birch pollen season.

Multicenter, international, parallel-group follow-up study of subjects randomized and treated in Study AN004T (AllerT 100 µg, AllerT 50 µg, placebo) and followed over the 2nd, and if appropriate, the 3rd and 4th birch pollen seasons in this study (still double-blind during the 1st year, open-label in the 2nd and 3rd years).

Inclusion Criteria:

1. Any subject having been randomized in the AN004T trial and had received at least one injection
2. Any subject having been informed and provided signed consent for participating in the trial and willing to follow all planned trial assessments

Exclusion Criteria:

1. Any subject having received specific immunotherapy against birch pollen or a tree pollen mix including birch pollen at any time since AN004T and before Visit 1
2. Any subject intending to travel during the birch pollen season outside of the birch pollination area for more than 7 consecutive days
3. Any subject unable or unwilling to record allergy symptoms and medications daily during the following birch pollen season using an electronic diary device
4. Any subject not covered by medical insurance
5. Any subject having received immunosuppressive medication within 4 weeks prior to inclusion, or planned to be used during the trial period
6. Any subject having received systemic or local antihistamines, oral or inhaled corticosteroids or under anti depressant medication with antihistamine effect within 2 weeks prior to inclusion
7. Any subject having used any investigational or non-registered drug, vaccine, or medical device within 4 weeks prior to inclusion, or planned to use such treatments during the trial period