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

This is a Phase 4, randomised, double‐blind, placebo‐controlled study to assess theefficacy and safety of short‐ and long‐term treatment with OM‐85.The study will consist of screening (up to 20 days before randomisation), Treatmentperiod 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 12consecutive months (BV‐12 arm), or OM‐85 for 3 consecutive months followed by matchingplacebo 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).