2024-511581-37-00招募中4 期
A Randomised, Placebo-Controlled, 3-Arm, Double-Blind, Multicentre, Phase 4 Study to Assess the Efficacy of OM-85 (Broncho Vaxom) Short- and Long-Term Treatment vs. Placebo in the Prevention of Respiratory Tract Infections in Children Aged Between 6 Months and 5 Years with Wheezing Lower Respiratory Illness
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- OM Pharma SA
- 入组人数
- 497
- 试验地点
- 27
- 主要终点
- Primary efficacy endpoint is the rate of RTIs during the 12-month Treatment period, defined as the number of RTIs experienced by a subject during the Treatment period.
研究概览
简要总结
Primary efficacy objective is to assess the efficacy of short- and long-term treatment with OM 85 vs. placebo in reducing the number of RTIs in children aged between 6 months and 5 years with recurrent RTIs associated with wLRI during the 12-month Treatment period.
入排标准
- 年龄范围
- 0 years 至 17 years（0-17 Years）
- 接受健康志愿者
- 是
入选标准
- •Children of either gender aged between 6 months and 5 years at Baseline/Randomisation (Visit 2), inclusive. As requested by the Central Ethics Committee, in Italy children can be enrolled if they are between 1 year and 5 years of age at baseline/Randomisation (Visit 2).
- •For children ≥1 year of age, ≥4 RTIs (as reported by parents or LAR of subject), including ≥2 episodes of wLRIs (including ≥1 triggering hospitalisation or medical visit) within 12 months prior to enrolment. OR For children <1 year of age, ≥2 RTIs (as reported by parents or LAR of subject), including ≥1 episode of wLRIs (including ≥1 triggering hospitalisation or medical visit) within 6 months prior to enrolment.
- •Parents or LAR of subject have provided the appropriate written informed consent. Written informed consent must be provided before any study-specific procedures are performed including screening procedures.
排除标准
- •Anatomic alterations of the respiratory tract.
- •Any known neoplasia or malignancy.
- •Treatment with the following medications: a. Injection or oral steroids administration within 4 weeks prior to study enrolment. b. Previous and/or concomitant immunosuppressants, immunostimulants, or gamma globulins within 6 months prior to study enrolment.
- •Previous use within last 6 months of enrolment or ongoing use of bacterial lysates.
- •Any major surgery within the last 3 months prior to study enrolment.
- •Known allergy or previous intolerance to investigational medicinal products (IMP).
- •Any other clinical conditions, that in the opinion of the Investigator, would not allow safe completion of the clinical study.
- •No other household members have previously been randomised in this clinical study.
- •Subjects' families expected to relocate out of study area within 24 months of the initiation of the study.
- •Currently enrolled in or has completed any other investigational device or drug study or receiving other investigational agent(s) within <30 days prior to screening.
- •Parents or LAR who do not have access to internet connection.
- •Other respiratory chronic diseases (e.g., tuberculosis, cystic fibrosis).
- •Wheezing documented to be caused by gastroesophageal reflux.
- •Any autoimmune disease.
- •HIV infection or any type of congenital or iatrogenic immune deficiency (including IgA deficiency).
- •Known severe congenital heart disease.
- •Haematologic diseases.
- •Liver or kidney failure.
- •New-borns before 34 weeks of gestational age.
- •Malnutrition as per World Health Organization (WHO) definition, meaning children having a weight lower than the 5th percentile and higher than the 85th percentile for their age range according to WHO weight for age charts from birth to 5 years. Children of 6 months of age at enrolment will be excluded from the study if they have a weight lower than 6 kg and 6.6 kg, for girls and boys respectively.
结局指标
主要结局
Primary efficacy endpoint is the rate of RTIs during the 12-month Treatment period, defined as the number of RTIs experienced by a subject during the Treatment period.
Primary efficacy endpoint is the rate of RTIs during the 12-month Treatment period, defined as the number of RTIs experienced by a subject during the Treatment period.
次要结局
- Rate of wLRIs during the 12-month Treatment period, defined as number of wLRIs experienced by a subject during the Treatment period.
研究者
Clinical Development Department
Scientific
OM Pharma SA
研究点 (27)
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