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
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 1,036
- 试验地点
- 33
- 主要终点
- Time From Taking the First Dose of the Study Drug to the Onset of Influenza/ARVI Symptoms.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 1 Month 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children of either gender aged from 1 month to 6 years old.
- •The absence of clinical symptoms of any infectious disease, but not earlier than 14 days from its onset.
- •Seasonal rise in ARVI incidence, confirmed by official information.
- •An information sheet (Informed Consent form) for the subject participation in the clinical trial signed by one parent/adopter of the patient.
排除标准
- •Acute or subacute period of infectious disease of any etiology (viral, bacterial, fungal, etc.) and localization (including upper and lower respiratory tract infection, meningitis, sepsis, otitis media, urinary tract infection, intestinal infection, etc.).
- •History of (verified previously) or current suspected conditions such as:
- •primary or secondary immunodeficiency;
- •bronchopulmonary dysplasia, primary ciliary dyskinesia, cystic fibrosis, other chronic pulmonary diseases;
- •malformations of the respiratory and ENT organs (ear, throat, mouth, tongue, larynx, trachea, neck and salivary and thyroid glands, etc.);
- •immunopathological diseases (including Marshall syndrome, Behсet's syndrome, Kawasaki disease, etc.);
- •hematological diseases (including agranulocytosis, leukemia);
- •oncologic conditions.
- •Exacerbated or decompensated of chronic diseases affecting the patienrt's ability to participate in the clinical trial.
- •Malabsorption syndrome, including congenital or acquired lactase or another disaccharide deficiency, galactosemia.
- •Allergy/intolerance to any component of the study drug.
- •Course administration of the drug products specified in the section 'Prohibited concomitant medications' within 2 weeks prior to enrollment.
- •Children whose parents/adopter parents will fail to comply with the observation requirements of the trial or with the intake regimen of the study drug, from the investigator's point of view.
- •Participation in other clinical trials within 3 month prior to enrollment in the study.
- •The patient's parent/adopter parent 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.
- •The patient's parent/adopter parent works for OOO "NPF "MATERIA MEDICA HOLDING" (i.e., the company's employee, part-time employee under contract or appointed official in charge of the trial, or their immediate family).
研究组 & 干预措施
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.
干预措施: Anaferon for children (Drug)
Placebo
Tablet for oral use. Placebo using Anaferon for children scheme.
干预措施: Placebo (Drug)
结局指标
主要结局
Time From Taking the First Dose of the Study Drug to the Onset of Influenza/ARVI Symptoms.
时间窗: in 12 weeks of the treatment
Based on medical records.
次要结局
- Percentage of Children With the Symptoms Requiring Antibacterial Therapy.(in 12 weeks of the treatment)
- Presence and Type of Adverse Events (AE).(in 12 weeks of the treatment)
- Percentage of Children Not Falling Ill With Influenza or Another ARVI.(in 12 weeks of the treatment)
- Percentage of Children Requiring Hospitalized for Influenza/ARVI.(in 12 weeks of the treatment)