Study to Assess Hypoallergenicity of a New Amino-acid Based Infant Formula in Children With Cow's Milk Allergy

Inclusion Criteria: * Children with documented cow's milk allergy, confirmed by one of the following criteria, within six months prior to study start (visit 2): * Positive double-blind, placebo-controlled oral food challenge (DBPCFC) with cow's milk OR * Positive open or single-blind oral food challenge with cow's milk carried out under the supervision of a specialist in children with clear immediate reactions and a positive test for specific IgE (in serum \[sIgE\>0,35 KUI/L\] or skin prick test \[SPT ≥ 3 mm\]) OR * Reported convincing allergic symptoms following an exposure to milk or a milk-containing food product and detectable serum milk-specific IgE or positive skin prick test * Aged ≤12 years of age at screening. * Expected consumption of a minimum of 250ml of study formula per day during the open challenge. * Written informed consent from one or both parents (depending on the local legislation) or legal representative. Exclusion Criteria: * Children who receive breastfeeding at study enrolment. * Had any chronic medical diseases, chromosomal or major congenital anomalies, or major gastrointestinal disease/abnormalities (other the CMPA); had immunodeficiency; antihistamine \[excluding eye drops\] use in 7 days prior to a food challenge or oral steroid use within 14 days prior to enrolment; unstable asthma; severe uncontrolled eczema; * Severe anaphylactic reaction \[required ≥ 2 doses of epinephrine\] to milk or breast milk within the past 2 years; * Existing illness that could interfere with formula acceptance or identification of allergic reactions. * Investigator's uncertainty about the willingness or ability of the parents to comply with the protocol requirements. * Participation in any other studies involving investigational or marketed products concomitantly or within two weeks prior to entry into the study.