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

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

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.

This is a Phase 4, randomised, double-blind, placebo-controlled study to assess the efficacy and safety of short- and long-term treatment with OM-85.

The study will consist of screening (up to 20 days before randomisation), Treatment period of 12 months, and an Observational period of 6 months.

The subjects will be randomised in a ratio of 1:1:1 ratio to receive either OM-85 for 12 consecutive months (BV-12 arm), or OM-85 for 3 consecutive months followed by matching placebo for 9 consecutive months (BV-3 arm), or placebo for 12 consecutive months (Placebo arm).

The expected duration of subject participation is 18 months (+20 days).

Inclusion Criteria:

• Children of either gender aged between 6 months and 5 years, at Baseline/Randomisation (Visit 2) 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.

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.

Exclusion Criteria:

• Anatomic alterations of the respiratory tract.

• Other chronic respiratory diseases (e.g., tuberculosis, cystic fibrosis).

• 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.

• Any known neoplasia or malignancy.

• Treatment with the following medications:

  1. Injection or oral administration of steroids within 4 weeks prior to study enrolment.
  2. 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.

• Wheezing documented to be caused by gastroesophageal reflux.