Objective. To evaluate the dynamics of the quality of life of children aged 0 to 7 years with acute respiratory viral infections (ARVI) of mild and moderate severity when adding the drug Kipferon® (a mixture of normal human immunoglobulin and recombinant interferon α-2b) to standard therapy, as well as to determine the effect of this drug on the infectious morbidity of patients during 3 months following the course of treatment. Patients and Methods. A multicenter observational clinical study conducted at 19 clinical centers in Russia in routine outpatient and polyclinic practice included 855 children aged 0 to 7 years; the mean age was 3.5 ± 1.7 years. There were 460 (53.8%) boys and 395 (46.2%) girls. There were 89 children aged 0 to 1 year; older children were 766. Patients were divided into 2 groups: the main group (n = 656), children from which received Kipferon® (rectal suppositories, according to the instructions for use) for 7 days in addition to standard symptomatic therapy, and the control group (n = 199). The children were examined on admission, on the 3–5th and 6-8th day from the beginning of treatment; 1 and 3 months after the end of the course of therapy. The severity of the main clinical symptoms was evaluated using a 10-point system. The legal representatives of all patients signed informed consent. Statistical analysis of the results was performed using the methods of descriptive and variation statistics, Student and Mann–Whitney criteria; differences were considered reliable at p < 0.05. Results. The initial general level of discomfort, as well as the degree of severity of 11 main symptoms of acute respiratory infection were comparable in both groups and significantly improved by the end of the treatment course. On the 3-5th day from the beginning of treatment in patients receiving Kipferon® preparation, statistically significant (p < 0.05) improvement in all leading manifestations of ARVI was revealed, while in the control group improvement was registered only in 8 symptoms out of 11. In infants of the main group by the 3–5th day of treatment, difficulties in feeding and falling asleep significantly (p < 0.05) decreased; older patients significantly better ate and slept, and were more physically active. Bacterial complications of ARVI in the main group developed 2 times less frequently: 36 (5.7%) cases vs. 20 (10.3%); the differences are reliable (p = 0.026) according to the χ2 criterion. Repeated acute respiratory viral infections during 3 months of follow-up were significantly (p < 0.05) more frequent in children who did not receive Kipferon® (47.5% vs. 20.3%). No serious adverse events were detected during the use of Kipferon® preparation. Adverse events were recorded in 2 patients, none of them was classified as related to the use of the study drug; serious adverse events were absent during the entire observation period. Conclusion. The efficacy and safety of the immunomodulating drug Kipferon® allows us to recommend it as an important addition to symptomatic agents in the treatment of acute respiratory infections in pediatrics. Key words: children, interferons, Kipferon®, acute respiratory viral infections