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
|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|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
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.
Tablet for oral use.
- 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.
- 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).
- 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.
- 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.
- 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.
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