Clinical Trial of Anaferon for Children Efficacy in Prevention of Influenza and Other ARVI

Launched by MATERIA MEDICA HOLDING · Sep 29, 2017

Keywords

ClinConnect Summary

Design: an international, multicenter, double-blind, placebo-controlled, randomized study in parallel groups.

The study will enroll children of either gender aged of 1 month to 6 years old. Children can participate in the study, regardless of the frequency of previous ARVI. A potential study participant should not be in the incubation (if known), prodromal, acute/subacute periods of any infectious disease (except for the recovery period). Schedule for enrollment of participants: during the period of a seasonal rise in influenza/ARVI incidence in the Russian Federation and the Republic of U...

Gender

ALL

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).