Diagnostic Accuracy and Safety of DBV1605 for the Diagnosis of Non-IgE Mediated Cow's Milk Allergy in Children

DISEASE GROUP Inclusion Criteria:

• Male or female subjects aged > 28 days to ≤ 24 months at Screening Visit
• Subjects with clinical symptoms suggestive of non-IgE mediated Cow's Milk Allergy
• Subjects with any type of diet containing daily products with cow's milk protein (e.g.cow's milk consumption, cow's milk partial elimination, partially hydrolyzed milk)prior to Screening Visit or who have started a cow's milk elimination diet not morethan 4 weeks prior to Screening Visit,
• Subjects/parents/guardians who agree to follow a strict cow's milk-free diet and othermammalian milks (such as sheep and goat's milk) as per study requirements.

Exclusion Criteria:

• Subjects with an established diagnosis of non-IgE mediated CMA
• Breast-fed subject at Screening Visit
• Subjects with a convincing history of IgE-mediated CMA
• Subjects on a cow's milk protein-free diet including an AA-based formula or anextensively hydrolyzed formula initiated more than 4 weeks prior to Screening Visit.
• Generalized dermatologic disease (e.g. severe atopic dermatitis, ) extending widely onthe skin.
• Any contraindication to a cow's milk challenge CONTROL GROUP Inclusion Criteria:
• Male or female subjects aged > 28 days to ≤ 24 months at Screening visit
• Subjects having no medical history of any type of allergy
• Subjects who tolerate at least 200 mL of cow's milk or equivalent dairy foods dailywithin 4 weeks prior to Screening visit Exclusion Criteria:
• Subjects with history of persistent gastro-intestinal symptoms
• Exclusively breast-fed subjects at Screening visit