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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| ClinicalTrials.gov Identifier: NCT03301155 |
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Recruitment Status :
Completed
First Posted : October 4, 2017
Last Update Posted : August 6, 2019
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Sponsor:
Materia Medica Holding
Information provided by (Responsible Party):
Materia Medica Holding
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Brief Summary:
The purpose of this study is to obtain additional data on 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.
Primary objectives of the study:
- To assess duration of the period from the first dose of the drug until manifestation of the symptoms of influenza or another acute respiratory viral infection (ARVI) in two groups of subjects receiving preventive therapy with the study drug (Anaferon for children) or Placebo.
- To compare duration of periods from the first dose of the drug until manifestation of the symptoms of influenza or another ARVI in two groups of subjects (Anaferon for children and Placebo).
- Based on the comparison of duration of periods from the first dose of the drug until manifestation of the symptoms of the disease in these two groups, to assess efficacy of Anaferon for children for prevention of influenza and other ARVI in children during the peaks of seasonal morbidity and demonstrate superiority of the study drug over placebo.
Additional study objectives:
- To assess and compare percentage of children not falling with influenza or another ARVI in the two groups during 4-, 8- and 12-week course of preventive therapy.
- To assess and compare percentage of children in the two groups with the symptoms of respiratory or ear-nose-throat bacterial infections requiring antibacterial therapy within 12-week preventive therapy.
- To assess and compare percentage of children hospitalized with influenza/ARVI or their complications in the two groups within 12-week preventive therapy.
- Based on collection and analysis of adverse events during the therapy, to obtain additional information on safety of the study drug
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Preventive Medicine | Drug: Anaferon for children Drug: Placebo | Phase 4 |
| 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
| Arm | Intervention/treatment |
|---|---|
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Experimental: Anaferon for children
The product should be administered apart from meal (between meals or 15 minutes prior to meal or drinking). The tablet should be held in the mouth until complete dissolution.
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Drug: Anaferon for children
Per os. 1 tablet once daily (preferably at the same time of the day). For children of younger age (from 1 month through 3 years) the tablet should be dissolved in a small amount (1 tablespoon) of boiled water of room temperature. |
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Placebo Comparator: Placebo
The product should be administered apart from meal (between meals or 15 minutes prior to meal or drinking). The tablet should be held in the mouth until complete dissolution.
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Drug: Placebo
Per os. 1 tablet once daily (preferably at the same time of the day). For children of younger age (from 1 month through 3 years) the tablet should be dissolved in a small amount (1 tablespoon) of boiled water of room temperature. |
Primary Outcome Measures :
- Duration of the period from the first dose of the study drug until manifestation of the symptoms of influenza or another acute respiratory viral infection (ARVI) [ Time Frame: in 12 weeks of the treatment ]
Secondary Outcome Measures :
- Percentage of children not falling with influenza or another ARVI during 4, 8 or 12-week preventive course [ 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 within 12-week preventive course [ Time Frame: in 12 weeks of the treatment ]based on medical records
- Percentage of children hospitalized for influenza or ARVI or their complications within 12-week preventive course [ Time Frame: in 12 weeks of the treatment ]based on medical records
- Presence and nature of adverse events, their intensity (severity), causality with the study drug; outcome [ Time Frame: in 12 weeks of the treatment ]
Information from the National Library of Medicine
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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:
- Children of both genders, aged from 1 month through 6 years inclusively.
- Absence of clinical signs of any infectious disease, however, not sooner than 14 days after the onset of the disease.
- Peak of seasonal morbidity for acute respiratory viral infections verified by official information (October through January).
- An information sheet (informed consent form) for parents/ adopter of child for participation in the study signed by one of the child's parents/adopters.
Exclusion Criteria:
- An acute or subacute infectious disease of any aetiology (viral, bacterial, fungal, etc.) or localization (including any upper and lower respiratory infections, meningitis, sepsis, otitis media, urinary infections, intestinal infections, etc.).
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History of (verified previously) or current suspected conditions:
- Primary or secondary immunodeficiency;
- Bronchopulmonary dysplasia, primary cilliary dyskinesia, cystic fibrosis, other chronic pulmonary diseases;
- Congenital abnormalities of respiratory or ear-nose-throat organs;
- Immune diseases (including Marshall syndrome, Behcet's disease, Kawasaki disease, etc.);
- Blood diseases (incl. agranulocytosis, leukemia);
- Oncology.
- Exacerbation or decompensation of a chronic disease possibly affecting the child's ability to participate in the clinical study.
- Malabsorption syndrome including congenital or acquired lactase or other disaccharide deficiency, galactosemia.
- Allergy/ intolerance of any of the components of the study drug.
- Course administration of the medicinal products listed in section "Forbidden concomitant therapy" within 2 weeks prior to the enrollment.
- The children whose parents/adopters, according to the investigator, will not be able to follow the requirements regarding monitoring during the study or comply with the dosing regimen.
- Participation in other clinical studies three months prior to enrollment into this study.
- A parent/adopter of child 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.
- A parent/adopter of child is working for OOO "NPF "Materia Medica Holding", i.e. is a company employee, a temporary contract worker, or an appointed person responsible for the conduction of the study or is a close relative of the above-mentioned persons.
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
| Responsible Party: | Materia Medica Holding |
| ClinicalTrials.gov Identifier: | NCT03301155 |
| Other Study ID Numbers: |
MMH-AD-008 |
| First Posted: | October 4, 2017 Key Record Dates |
| Last Update Posted: | August 6, 2019 |
| Last Verified: | May 2019 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
Additional relevant MeSH terms:
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Virus Diseases |