HEALSea Nasal Spray for Prevention of Infections in Children

Healsea® Children is a class IIa medical device. This is an isotonic seawater-based nasal spray supplemented with a natural Symbiofilm™ extract (0.02%) isolated from marine bacteria. Healsea® Children is indicated in children above 6 years to clean and moisten the nose during colds. Symbiofilm™, which is not a medicinal product is able to protect the nasal mucosa from viruses' entrance by forming a protective barrier on the nasal mucosa. By targeting the nose as entry points for viruses, we hypothesise that Healsea® Children used regularly during the respiratory virus season may prevent upper respiratory tracts infections such as cold or flu with nasal symptoms. The main objective of this premarket clinical investigation is thus to assess the efficacy of Healsea® Children to prevent upper respiratory tract infections with nasal symptoms in healthy children during 3 treatment periods of 28 days interspersed by 2 wash-out periods of 10 days when compared to children not taking Healsea® Children. 138 children will be randomised in the study, 64 in the Healsea® Children group and 64 in the non-treated group. The subjects (or their parents) will be asked to report the upper respiratory tract infections with nasal symptoms and complication they may have during the study to the physician in charge of the study conduct. Two study visits and 3 telephone calls are scheduled. The subjects will also complete an electronic diary to report nasal symptoms and adverse event other than upper respiratory tracts infections.