OM-85 in Paediatric Recurrent Respiratory Tract Infections With Wheezing Lower Respiratory Illness

This study will assess the efficacy and safety of OM-85 compared to placebo in reducing the number of respiratory tract infections (RTIs) in children aged between 6 months and 5 years.

Inclusion Criteria:Children of either gender aged between 6 months and 5 years, inclusive.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.ORFor 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.Exclusion Criteria:Anatomic alterations of the respiratory tract.Other respiratory chronic diseases (e.g., tuberculosis, cystic fibrosis).Any autoimmune disease.HIV infection or any type of congenital or iatrogenic immune deficiency (including IgA deficiency).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.Any known neoplasia or malignancy.Treatment with the following medications:Systemic or oral steroids (e.g., oral prednisolone) within 4 weeks prior to study enrolment.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.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 legally acceptable representative (LAR) who do not have access to internet connection.