Clinical Trial of Anaferon for Children Efficacy in Prevention of Influenza and Other ARVI
Condition: Preventive Medicine
Intervention: Anaferon for children; Placebo
Intervention description: Tablet for oral use.; Tablet for oral use.
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 1036.0
Sex: All
Minimum age: 1 Month
Maximum age: 6 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The objective of this study is to obtain additional data on the efficacy and safety of
      12-week course of therapy with Anaferon for children for prevention of influenza and other
      acute respiratory viral infections in children during the peaks of seasonal morbidity.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Children of either gender aged from 1 month to 6 years old.

          2. The absence of clinical symptoms of any infectious disease, but not earlier than 14
             days from its onset.

          3. Seasonal rise in ARVI incidence, confirmed by official information.

          4. An information sheet (Informed Consent form) for the subject participation in the
             clinical trial signed by one parent/adopter of the patient.

        Exclusion Criteria:

          1. Acute or subacute period of infectious disease of any etiology (viral, bacterial,
             fungal, etc.) and localization (including upper and lower respiratory tract infection,
             meningitis, sepsis, otitis media, urinary tract infection, intestinal infection,
             etc.).

          2. History of (verified previously) or current suspected conditions such as:

               -  primary or secondary immunodeficiency;

               -  bronchopulmonary dysplasia, primary ciliary dyskinesia, cystic fibrosis, other
                  chronic pulmonary diseases;

               -  malformations of the respiratory and ENT organs (ear, throat, mouth, tongue,
                  larynx, trachea, neck and salivary and thyroid glands, etc.);

               -  immunopathological diseases (including Marshall syndrome, Behсet's syndrome,
                  Kawasaki disease, etc.);

               -  hematological diseases (including agranulocytosis, leukemia);

               -  oncologic conditions.

          3. Exacerbated or decompensated of chronic diseases affecting the patienrt's ability to
             participate in the clinical trial.

          4. Malabsorption syndrome, including congenital or acquired lactase or another
             disaccharide deficiency, galactosemia.

          5. Allergy/intolerance to any component of the study drug.

          6. Course administration of the drug products specified in the section 'Prohibited
             concomitant medications' within 2 weeks prior to enrollment.

          7. Children whose parents/adopter parents will fail to comply with the observation
             requirements of the trial or with the intake regimen of the study drug, from the
             investigator's point of view.

          8. Participation in other clinical trials within 3 month prior to enrollment in the
             study.

          9. The patient's parent/adopter parent is a member of the research team of the
             investigational site directly involved in the study or a close relative of an
             investigator. Close relatives are defined as husband/wife, parents, children, brothers
             (sisters) regardless of whether they are biological or adopted.

         10. The patient's parent/adopter parent works for OOO "NPF "MATERIA MEDICA HOLDING" (i.e.,
             the company's employee, part-time employee under contract or appointed official in
             charge of the trial, or their immediate family).