Last updated on August 2019

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


Brief description of study

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:

  1. 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.
  2. 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).
  3. 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:

  1. 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.
  2. 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.
  3. To assess and compare percentage of children hospitalized with influenza/ARVI or their complications in the two groups within 12-week preventive therapy.
  4. Based on collection and analysis of adverse events during the therapy, to obtain additional information on safety of the study drug

Clinical Study Identifier: NCT03301155

Recruitment Status: Closed


Brief Description Eligibility Contact Research Team


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