Safety Study of Ragweed Allergy Immunotherapy Tablet in Subjects 50 Years of Age and Older (Study P06081)

Inclusion criteria

• Subject must be 50 years of age or older, of either sex, and of any race/ethnicity.
• Subject must have a clinical history of ragweed-induced allergic rhinoconjunctivitis with or without asthma.
• Subject must have a positive skin prick test response to Ambrosia artemisiifolia at the Screening Visit
• Subject must have a forced expiratory volume in 1 second (FEV1) of at least 70% of predicted value at the Screening Visit and at Randomization.
• A subject's clinical laboratory tests, electrocardiogram (ECG) and vital signs conducted at the Screening Visit must be within normal limits or clinically acceptable to the investigator.

Exclusion criteria

• Subject with asthma who requires inhaled corticosteroids for the treatment of their asthma during the study period.
• Subject requiring anti-allergy medications during the time period from randomization to study completion.
• Subject who has received an immunosuppressive treatment within 3 months prior to the Screening Visit (except steroids for allergic and asthma symptoms).
• Subject with a history of anaphylaxis with cardiorespiratory symptoms.
• Subject with a history of chronic urticaria or angioedema.
• Subject with current severe atopic dermatitis.
• Female subject who is breastfeeding, pregnant, or intending to become pregnant.
• Subject with a history of allergy, hypersensitivity or intolerance to the ingredients of the investigational medicinal products (IMPs) (except for Ambrosia artemisiifolia), or self-injectable epinephrine.
• Subject with a history of self-injectable epinephrine use.