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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
Recruitment Status : Recruiting
First Posted : October 4, 2017
Last Update Posted : January 11, 2019
Sponsor:
Information provided by (Responsible Party):
Materia Medica Holding

Study Description
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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:

  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

Condition or disease Intervention/treatment Phase
Preventive Medicine Drug: Anaferon for children Drug: Placebo Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : July 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot

Arms and Interventions
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Arm Intervention/treatment
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.
 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.
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.
 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.


Outcome Measures
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Primary Outcome Measures :
  1. 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 :
  1. 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

  2. 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

  3. 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

  4. Presence and nature of adverse events, their intensity (severity), causality with the study drug; outcome [ Time Frame: in 12 weeks of the treatment ]

Eligibility Criteria
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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:

  1. Children of both genders, aged from 1 month through 6 years inclusively.
  2. Absence of clinical signs of any infectious disease, however, not sooner than 14 days after the onset of the disease.
  3. Peak of seasonal morbidity for acute respiratory viral infections verified by official information (October through January).
  4. 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:

  1. 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.).

  2. 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.
  3. Exacerbation or decompensation of a chronic disease possibly affecting the child's ability to participate in the clinical study.
  4. Malabsorption syndrome including congenital or acquired lactase or other disaccharide deficiency, galactosemia.
  5. Allergy/ intolerance of any of the components of the study drug.
  6. Course administration of the medicinal products listed in section "Forbidden concomitant therapy" within 2 weeks prior to the enrollment.
  7. 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.
  8. Participation in other clinical studies three months prior to enrollment into this study.
  9. 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.
  10. 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.
Contacts and Locations
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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


Contacts
Contact: Mikhail Putilovskiy, MD, PhD +74952761571 ext 302 PutilovskiyMA@materiamedica.ru

Locations
Russian Federation
Municipal Autonomous Institution "Children's City Clinical Hospital No. 11" Recruiting
Ekaterinburg, Russian Federation, 620028
Contact: Sophia Tsarkova, Prof         
Principal Investigator: Sophia Tsarkova, Prof         
Regional budgetary health care institution "Regional Children's Clinical Hospital" Recruiting
Ivanovo, Russian Federation, 153040
Contact: Olga Votyakova, Prof         
Principal Investigator: Olga Votyakova, Prof         
Republican Children's Clinical Hospital of the Ministry of Health of the Udmurt Republic Not yet recruiting
Izhevsk, Russian Federation, 426009
Contact: Tatyana Kovalenko, MD, PhD, Prof         
Principal Investigator: Tatyana Kovalenko, MD, PhD, Prof         
Federal State Budgetary Educational Institution of Higher Education "Kazan Medical University" of the Ministry of Healthcare of the Russian Federation Recruiting
Kazan, Russian Federation, 420012
Contact: Ildar Nurmeev, PhD         
Principal Investigator: Ildar Nurmeev, PhD         
Kazan Federal University Not yet recruiting
Kazan, Russian Federation, 420012
Contact: Dina Gaynetdinova, MD, PhD, Prof         
Principal Investigator: Dina Gaynetdinova, MD, PhD, Prof         
Federal Budget Institution of Science "Central Research Institute of Epidemiology" of The Federal Service on Customers' Rights Protection and Human Well-being Surveillance Completed
Moscow, Russian Federation, 111123
Federal State Budgetary Educational Institution of Higher Education "Pirogov Russian National Research Medical University" of the Ministry of Healthcare of the Russian Federation Recruiting
Moscow, Russian Federation, 117997
Contact: Vadim Steshin, MD         
Principal Investigator: Vadim Steshin, MD         
State Federal-Funded Educational Institution of Higher Professional Training I.M. Sechenov First Moscow State Medical University of the Ministry of Health of the Russian Federation Recruiting
Moscow, Russian Federation, 119991
Contact: Natalia Geppe, MD, PhD, ScD, professor         
Principal Investigator: Natalia Geppe, MD, PhD, ScD, professor         
LLC Center for Vaccine Prevention "DIAVAKS" Recruiting
Moscow, Russian Federation, 129515
Contact: Olga Shamsheva, MD, PhD         
Principal Investigator: Olga Shamsheva, MD, PhD         
Limited Liability Company "Gubernskiy lekar'" Recruiting
Murmansk, Russian Federation, 183038
Contact: Vera Rodnikova, MD         
Principal Investigator: Vera Rodnikova, MD         
Limited Liability Company "MDP-Medical Group" Not yet recruiting
Odintsovo, Russian Federation, 143005
Contact: Yuriy Mizernitsky, MD, PhD, Prof         
Principal Investigator: Yuriy Mizernitsky, MD, PhD, Prof         
Federal State Budgetary Educational Institution of Higher Education "Orenburg State Medical University" of the Ministry of Healthcare of the Russian Federation Completed
Orenburg, Russian Federation, 460000
Municipal Health Care Institution "City Child Health Clinical Polyclinic №5" Completed
Perm, Russian Federation, 614066
Municipal Budgetary Health Care Institutions "Semashko City Hospital №1 Rostov-on-Don " Completed
Rostov-na-Donu, Russian Federation, 344000
Municipal budgetary health care institution "Children's city polyclinic №4" Completed
Rostov-na-Donu, Russian Federation, 344065
St. Petersburg State Budgetary Healthcare Institution "Children's City Polyclinic No. 44" Completed
Saint Petersburg, Russian Federation, 191144
St. Petersburg State Budgetary Health Care Institution "Сity Polyclinic №44" Recruiting
Saint Petersburg, Russian Federation, 192212
Contact: Olga Jiglinskaya, MD         
Principal Investigator: Olga Jiglinskaya, MD         
Federal State Budgetary Educational Institution of Higher Education "St. Petersburg State Pediatric Medical Academy" of Ministry of Health of Russian Federation Completed
Saint Petersburg, Russian Federation, 194100
St. Petersburg State Budgetary Healthcare Institution "Children's City Polyclinic No. 35" Completed
Saint Petersburg, Russian Federation, 196191
St. Petersburg State Budgetary Healthcare Institution "Children's City Hospital No. 22" Recruiting
Saint Petersburg, Russian Federation, 196650
Contact: Marina Koshchavceva, MD         
Principal Investigator: Marina Koshchavceva, MD         
Samara Regional Children's Sanatorium "Yunost'" Recruiting
Samara, Russian Federation, 443031
Contact: Natalia Mokina, MD, PhD, Prof         
Principal Investigator: Natalia Mokina, MD, PhD, Prof         
State Budgetary Institution of Health of the Samara Region "Samara City Children's Clinical Hospital No. 1 named after N.N. Ivanova" Recruiting
Samara, Russian Federation, 443079
Contact: Tatyana Romanova, MD         
Principal Investigator: Tatyana Romanova, MD         
Limited Liability Company "DNA Research Center" Recruiting
Saratov, Russian Federation, 410005
Contact: Olga Panina, MD, PhD         
Principal Investigator: Olga Panina, MD, PhD         
Regional State Autonomous Healthcare Institution "Children's Hospital №1" Recruiting
Tomsk, Russian Federation, 634050
Contact: Elena Tuteva, MD, PhD         
Principal Investigator: Elena Tuteva, MD, PhD         
Siberian State Medical University Recruiting
Tomsk, Russian Federation, 634050
Contact: Larisa Lukashova, MD, PhD         
Principal Investigator: Larisa Lukashova, MD, PhD         
Bashkir State Medical University Not yet recruiting
Ufa, Russian Federation, 450008
Contact: Lyudmila Yakovleva, MD, PhD, Prof         
Principal Investigator: Lyudmila Yakovleva, MD, PhD, Prof         
Volgograd State Medical University Recruiting
Volgograd, Russian Federation, 400131
Contact: Olga Magnitskaya, MD, PhD         
Principal Investigator: Olga Magnitskaya, MD, PhD         
Volgograd State Medical University Recruiting
Volgograd, Russian Federation, 400131
Contact: Ivan Shishimorov, MD, PhD         
Principal Investigator: Ivan Shishimorov, MD, PhD         
Federal State Budgetary Educational Institutionof Higher Education "Yaroslavl State Medical University" of the Ministry of Healthcare of the Russian Federation Completed
Yaroslavl, Russian Federation, 150000
Federal State Budgetary Educational Institutionof Higher Education "Yaroslavl State Medical University" of the Ministry of Healthcare of the Russian Federation Recruiting
Yaroslavl, Russian Federation, 150000
Contact: Nataliya Chernaya, MD, PhD         
Principal Investigator: Nataliya Chernaya, MD, PhD         
Federal State Budgetary Educational Institutionof Higher Education "Yaroslavl State Medical University" of the Ministry of Healthcare of the Russian Federation Recruiting
Yaroslavl, Russian Federation, 150000
Contact: Elena Sitnikova, Prof         
Principal Investigator: Elena Sitnikova, Prof         
Uzbekistan
Family polyclinic № 6 Completed
Tashkent, Uzbekistan, 100194
Sponsors and Collaborators
Materia Medica Holding
More Information
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Responsible Party: Materia Medica Holding
ClinicalTrials.gov Identifier: NCT03301155     History of Changes
Other Study ID Numbers: MMH-AD-008
First Posted: October 4, 2017    Key Record Dates
Last Update Posted: January 11, 2019
Last Verified: January 2019

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Virus Diseases