Status:
COMPLETED
Clinical Trial of Anaferon for Children Efficacy in Prevention of Influenza and Other ARVI
Lead Sponsor:
Materia Medica Holding
Conditions:
Preventive Medicine
Eligibility:
All Genders
1-6 years
Phase:
PHASE4
Brief 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 vira...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- Children of either gender aged from 1 month to 6 years old.
- The absence of clinical symptoms of any infectious disease, but not earlier than 14 days from its onset.
- Seasonal rise in ARVI incidence, confirmed by official information.
- An information sheet (Informed Consent form) for the subject participation in the clinical trial signed by one parent/adopter of the patient.
Exclusion
- 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.).
- 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.
- Exacerbated or decompensated of chronic diseases affecting the patienrt's ability to participate in the clinical trial.
- Malabsorption syndrome, including congenital or acquired lactase or another disaccharide deficiency, galactosemia.
- Allergy/intolerance to any component of the study drug.
- Course administration of the drug products specified in the section 'Prohibited concomitant medications' within 2 weeks prior to enrollment.
- 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.
- Participation in other clinical trials within 3 month prior to enrollment in the study.
- 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.
- 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).
Key Trial Info
Start Date :
October 3 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 20 2019
Estimated Enrollment :
1036 Patients enrolled
Trial Details
Trial ID
NCT03301155
Start Date
October 3 2017
End Date
May 20 2019
Last Update
May 6 2020
Active Locations (33)
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1
Regional budgetary health care institution "Regional Children's Clinical Hospital"
Ivanovo, Russia, 153040
2
Republican Children's Clinical Hospital of the Ministry of Health of the Udmurt Republic
Izhevsk, Russia, 426009
3
Federal State Budgetary Educational Institution of Higher Education "Kazan Medical University" of the Ministry of Healthcare of the Russian Federation
Kazan', Russia, 420012
4
Kazan Federal University
Kazan', Russia, 420012