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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT03301155 |
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Date of registration:
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29/09/2017 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Clinical Trial of Anaferon for Children Efficacy in Prevention of Influenza and Other ARVI
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Scientific title:
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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 |
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Date of first enrolment:
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October 3, 2017 |
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Target sample size:
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1036 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03301155 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
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Phase:
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Phase 4
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Countries of recruitment
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Kazakhstan
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Russian Federation
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Uzbekistan
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Key inclusion & exclusion criteria
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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, Beh?et'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).
Age minimum:
1 Month
Age maximum:
6 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Preventive Medicine
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Intervention(s)
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Drug: Anaferon for children
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Drug: Placebo
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Primary Outcome(s)
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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]
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Secondary Outcome(s)
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Percentage of Children With the Symptoms Requiring Antibacterial Therapy.
[Time Frame: in 12 weeks of the treatment]
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Presence and Type of Adverse Events (AE).
[Time Frame: in 12 weeks of the treatment]
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Percentage of Children Not Falling Ill With Influenza or Another ARVI.
[Time Frame: in 12 weeks of the treatment]
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Percentage of Children Requiring Hospitalized for Influenza/ARVI.
[Time Frame: in 12 weeks of the treatment]
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Secondary ID(s)
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MMH-AD-008
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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