Clinical Trial of Anaferon for Children Efficacy in Prevention of Influenza and Other ARVI
Condition: Preventive Medicine
Study type: Interventional
Phase: Phase 4

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.
    

Detailed description: 
      Design: an international, multicenter, double-blind, placebo-controlled, randomized study in
      parallel groups.

      The study will enroll children of either gender aged of 1 month to 6 years old. Children can
      participate in the study, regardless of the frequency of previous ARVI. A potential study
      participant should not be in the incubation (if known), prodromal, acute/subacute periods of
      any infectious disease (except for the recovery period). Schedule for enrollment of
      participants: during the period of a seasonal rise in influenza/ARVI incidence in the Russian
      Federation and the Republic of Uzbekistan. Screening and randomization of participants will
      be subject to availability of official information on the incidence of influenza/ARVI in the
      relevant study region.

      The doctor makes the first visit to the participant in the medical center or at home. After
      the parent/adoptive parent signs the information sheet (informed consent form), the doctor
      evaluates the possibility of the participant being included in the trial. If the child meets
      all the inclusion criteria and does not have all non-inclusion criteria, then he/she is
      included in the study, the doctor fills in Clinical Research Form. At visit 1 (Day 1), the
      participant is randomized into one of two groups: the 1st group participants will take
      Anaferon for children according to the preventive regimen for 12 weeks; the 2nd group
      participants will take Placebo according to the regimen of Anaferon for 12 weeks.

      In total, the study participant will be observed for 12 weeks (screening and randomization up
      to 1 day, preventive treatment for 12 weeks).

      During the observation period at 4 (Visit 2), 8 (Visit 3) and 12 (Visit 4) weeks, three
      visits are planned.

      Visits 2 (Week 4 ± 3 days) and 3 (Week 8 ± 3 days) are conducted in the form of a telephone
      survey of parents/adoptive parents about the participant's health status, presence/absence of
      symptoms of influenza/ARVI, possible use of antibacterial drugs and/or hospitalization during
      the course preventive therapy.

      Visit 4 (Week 12 ± 3 days) is carried out at home or in a medical center; the doctor collects
      complaints, examines the participant, registers concomitant therapy, assesses the compliance
      of the therapy.

      If in the period from 2 to 12 weeks a participant falls ill with influenza/ARVI, then he/she
      prematurely completes participation in the study (as having reached the primary endpoint). A
      participant is considered fallen ill with influenza/ARVI if the doctor identifies the
      following symptoms: febrile/subfebrile body temperature, presence at least one flu-like
      nonspecific symptom (decreased activity/impaired behavior/weakness; headache; chills) and at
      least one respiratory symptom (runny nose; nasal stuffiness; hoarseness/husky voice; sore
      throat; cough). In this case, the doctor makes an unscheduled visit (at home or in a medical
      center), which is final. During the visit, the doctor carries out the procedures of Visit 4.
      A nasopharyngeal swab is taken to identify the most common pathogens of influenza/ARVI.

      If ARVI/influenza occurs within the first seven days from the onset of preventive therapy,
      the disease will not be recorded as an adverse event and will not be taken into account to
      evaluate the efficacy of the study drug, since an early manifestation of influenza/ARVI may
      indicate that the participant was included in the study when he/she was in the incubation
      period of an infectious disease.

      During the study, concomitant therapy for underlying chronic conditions, as well as routine
      vaccination of the participant, are allowed, with the exception of the drugs indicated in the
      section "Prohibited Concomitant Treatment".
    

Intervention name(s): Anaferon for children; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Tablet for oral use.; Tablet for oral use.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention