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

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ClinicalTrials.gov Identifier: NCT03301155
Recruitment Status : Completed
First Posted : October 4, 2017
Results First Posted : May 6, 2020
Last Update Posted : May 6, 2020
Sponsor:
Information provided by (Responsible Party):
Materia Medica Holding

Study Description
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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.

Condition or disease Intervention/treatment Phase
Preventive Medicine Drug: Anaferon for children Drug: Placebo Phase 4

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Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1036 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: International Multicenter Double-bind Placebo-controlled Randomized Parallel-group Clinical Trial of Anaferon for Children Efficacy in Prevention of Influenza and Other Acute Respiratory Viral Infections in Children During the Peaks of Seasonal Morbidity
Actual Study Start Date : October 3, 2017
Actual Primary Completion Date : May 20, 2019
Actual Study Completion Date : May 20, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot

Arms and Interventions
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Arm Intervention/treatment
Experimental: Anaferon for children

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
Tablet for oral use.
Placebo Comparator: Placebo
Tablet for oral use. Placebo using Anaferon for children scheme.
 Drug: Placebo
Tablet for oral use.


Outcome Measures
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Primary Outcome Measures :
  1. Time From Taking the First Dose of the Study Drug to the Onset of Influenza/ARVI Symptoms. [ Time Frame: in 12 weeks of the treatment ]
    Based on medical records.


Secondary Outcome Measures :
  1. Percentage of Children Not Falling Ill With Influenza or Another ARVI. [ Time Frame: in 12 weeks of the treatment ]
    Based on medical records. Influenza/ARVI criteria are the following: febrile/subfebrile body temperature, presence at least one flu-like nonspecific symptom (decreased activity/weakness, headache, and chills), and at least one respiratory symptom (runny nose, nasal stuffiness, hoarseness/husky voice, sore throat, and cough).

  2. Percentage of Children With the Symptoms Requiring Antibacterial Therapy. [ Time Frame: in 12 weeks of the treatment ]
    Based on medical records. Percentage of children with the symptoms of a respiratory or ear-nose-throat bacterial infection requiring antibacterial therapy.

  3. Percentage of Children Requiring Hospitalized for Influenza/ARVI. [ Time Frame: in 12 weeks of the treatment ]
    Based on medical records. Percentage of children hospitalized for influenza/ARVI or their complications.

  4. Presence and Type of Adverse Events (AE). [ Time Frame: in 12 weeks of the treatment ]
    Based on medical records. Presence and type of adverse events, their severity, relation to investigational drug, outcomes.


Eligibility Criteria
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Ages Eligible for Study:   1 Month to 6 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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).
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03301155


Locations
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Sponsors and Collaborators
Materia Medica Holding
  Study Documents (Full-Text)

Documents provided by Materia Medica Holding:
Study Protocol and Statistical Analysis Plan  [PDF] August 23, 2018

More Information
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Responsible Party: Materia Medica Holding
ClinicalTrials.gov Identifier: NCT03301155    
Other Study ID Numbers: MMH-AD-008
First Posted: October 4, 2017    Key Record Dates
Results First Posted: May 6, 2020
Last Update Posted: May 6, 2020
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No