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

NCT03301155 | Completed Phase 4 Results

• 1 other identifier: MMH-AD-008
• Study Type: interventional
• Target: 1,036
• Locations: 2 countries
• Sites: 33

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 viral infections in children during the peaks of seasonal morbidity.

Conditions

Preventive Medicine

Outcome Measures

Primary Outcomes (1)

• Time From Taking the First Dose of the Study Drug to the Onset of Influenza/ARVI Symptoms.

  Based on medical records.

  in 12 weeks of the treatment

Secondary Outcomes (4)

• Percentage of Children Not Falling Ill With Influenza or Another ARVI.

  in 12 weeks of the treatment

• Percentage of Children With the Symptoms Requiring Antibacterial Therapy.

  in 12 weeks of the treatment

• Percentage of Children Requiring Hospitalized for Influenza/ARVI.

  in 12 weeks of the treatment

• Presence and Type of Adverse Events (AE).

  in 12 weeks of the treatment

Study Arms (2)

Anaferon for children

EXPERIMENTAL

Tablet for oral use. One tablet per intake, once daily (approximately at the same time). The product is administered outside a meal (in the interval between meals or 15 min prior to meal or fluid intake), the tablets should be held in mouth until complete dissolution. For young children (aged 1 month to 3 years old), the tablet is recommended to be dissolved in a small amount (1 tablespoon) of drinking water of room temperature.

Drug: Anaferon for children

Placebo

PLACEBO COMPARATOR

Tablet for oral use. Placebo using Anaferon for children scheme.

Drug: Placebo

Interventions

Anaferon for children DRUG

Tablet for oral use.

Anaferon for children

Placebo DRUG

Tablet for oral use.

Placebo

Eligibility Criteria

• Age: 1 Month - 6 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Materia Medica Holding: lead

Study Sites (33)

Regional budgetary health care institution "Regional Children's Clinical Hospital"

Ivanovo, 153040, Russia

Location

Republican Children's Clinical Hospital of the Ministry of Health of the Udmurt Republic

Izhevsk, 426009, Russia

Location

Federal State Budgetary Educational Institution of Higher Education "Kazan Medical University" of the Ministry of Healthcare of the Russian Federation

Kazan', 420012, Russia

Location

Kazan Federal University

Kazan', 420012, Russia

Location

Federal Budget Institution of Science "Central Research Institute of Epidemiology" of The Federal Service on Customers' Rights Protection and Human Well-being Surveillance

Moscow, 111123, Russia

Location

Federal State Budgetary Educational Institution of Higher Education "Pirogov Russian National Research Medical University" of the Ministry of Healthcare of the Russian Federation

Moscow, 117997, Russia

Location

State Federal-Funded Educational Institution of Higher Professional Training I.M. Sechenov First Moscow State Medical University of the Ministry of Health of the Russian Federation

Moscow, 119991, Russia

Location

LLC Center for Vaccine Prevention "DIAVAKS"

Moscow, 129515, Russia

Location

Limited Liability Company "Gubernskiy lekar'"

Murmansk, 183038, Russia

Location

Limited Liability Company "MDP-Medical Group"

Odintsovo, 143005, Russia

Location

Federal State Budgetary Educational Institution of Higher Education "Orenburg State Medical University" of the Ministry of Healthcare of the Russian Federation

Orenburg, 460000, Russia

Location

Municipal Health Care Institution "City Child Health Clinical Polyclinic №5"

Perm, 614066, Russia

Location

Municipal Budgetary Health Care Institutions "Semashko City Hospital №1 Rostov-on-Don "

Rostov-on-Don, 344000, Russia

Location

Municipal budgetary health care institution "Children's city polyclinic №4"

Rostov-on-Don, 344065, Russia

Location

St. Petersburg State Budgetary Healthcare Institution "Children's City Polyclinic No. 44"

Saint Petersburg, 191144, Russia

Location

St. Petersburg State Budgetary Health Care Institution "Сity Polyclinic №44"

Saint Petersburg, 192212, Russia

Location

Federal State Budgetary Educational Institution of Higher Education "St. Petersburg State Pediatric Medical Academy" of Ministry of Health of Russian Federation

Saint Petersburg, 194100, Russia

Location

St. Petersburg State Budgetary Healthcare Institution "Children's City Polyclinic No. 35"

Saint Petersburg, 196191, Russia

Location

St. Petersburg State Budgetary Healthcare Institution "Children's City Hospital No. 22"

Saint Petersburg, 196650, Russia

Location

Samara Regional Children's Sanatorium "Yunost'"

Samara, 443031, Russia

Location

State Budgetary Institution of Health of the Samara Region "Samara City Children's Clinical Hospital No. 1 named after N.N. Ivanova"

Samara, 443079, Russia

Location

Limited Liability Company "DNA Research Center"

Saratov, 410005, Russia

Location

Regional State Autonomous Healthcare Institution "Children's Hospital №1"

Tomsk, 634050, Russia

Location

Siberian State Medical University

Tomsk, 634050, Russia

Location

Bashkir State Medical University

Ufa, 450008, Russia

Location

Volgograd State Medical University/Departmental Clinical Hospital at Volgograd-1 Station of Russian Railways

Volgograd, 400131, Russia

Location

Volgograd State Medical University/Volgograd Regional Clinical Hospital # 1

Volgograd, 400131, Russia

Location

Yaroslavl State Medical University/Children's Clinic # 5

Yaroslavl, 150000, Russia

Location

Yaroslavl State Medical University/Clinical Hospital # 8 (Children's Clinic # 1)

Yaroslavl, 150000, Russia

Location

Yaroslavl State Medical University/Department of Infectious Diseases, Epidemiology and Children's Diseases

Yaroslavl, 150000, Russia

Location

Yaroslavl State Medical University/Regional Children's Clinical Hospital # 8 (Children's Clinic # 2)

Yaroslavl, 150000, Russia

Location

Municipal Autonomous Institution "Children's City Clinical Hospital No. 11"

Yekaterinburg, 620028, Russia

Location

Family polyclinic № 6

Tashkent, 100194, Uzbekistan

Location

MeSH Terms

Interventions

anaferon

Results Point of Contact

• Title: Michael Putilovskiy, MD, PhD, Clinical and Medical Department Director
• Organization: Materia Medica Holding

PutilovskiyMA@materiamedica.ru

+74952761571

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 29, 2017
• First Posted: October 4, 2017
• Study Start: October 3, 2017
• Primary Completion: May 20, 2019
• Study Completion: May 20, 2019
• Last Updated: May 6, 2020
• Results First Posted: May 6, 2020

Record last verified: 2019-05

Locations

UZ (1); RU (32)