Lyophilized bacterial lysates of: Haemophilus influenzae, Streptococcus (Diplococcus) pneumoniae, Klebsiella pneumoniae and ozaenae, Staphylococcus aureus, Streptococcus pyogenes and viridans, Moraxella (Branhamella/Neisseria) catarrhalis (OM-85) for Respiratory tract infections with wheezing lower respiratory illness

Inclusion criteria

• {"criterion_text":"- 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).\n- 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.\n- 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

• {"criterion_text":"- Anatomic alterations of the respiratory tract.\n- Any known neoplasia or malignancy.\n- 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.\n- Previous use within last 6 months of enrolment or ongoing use of bacterial lysates.\n- Any major surgery within the last 3 months prior to study enrolment.\n- Known allergy or previous intolerance to investigational medicinal products (IMP).\n- Any other clinical conditions, that in the opinion of the Investigator, would not allow safe completion of the clinical study.\n- No other household members have previously been randomised in this clinical study.\n- Subjects' families expected to relocate out of study area within 24 months of the initiation of the study.\n- 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.\n- Parents or LAR who do not have access to internet connection.\n- Other respiratory chronic diseases (e.g., tuberculosis, cystic fibrosis).\n- Wheezing documented to be caused by gastroesophageal reflux.\n- Any autoimmune disease.\n- HIV infection or any type of congenital or iatrogenic immune deficiency (including IgA deficiency).\n- Known severe congenital heart disease.\n- Haematologic diseases.\n- Liver or kidney failure.\n- New-borns before 34 weeks of gestational age.\n- 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."}

Primary endpoints

• {"endpoint_text":"- 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.","definition_or_measurement_approach":"Defined as the number of RTIs experienced by a subject during the 12-month Treatment period (i.e. rate of RTIs during the 12-month Treatment period)."}

Secondary endpoints

• {"endpoint_text":"- Rate of wLRIs during the 12-month Treatment period, defined as number of wLRIs experienced by a subject during the Treatment period.","definition_or_measurement_approach":"Defined as the number of wheezing lower respiratory illness (wLRI) episodes experienced by a subject during the 12-month Treatment period."}

Methods

• Physician referral letters (Physician Referral Letter documents present) to refer eligible paediatric patients via participating sites.
• Printed materials and local outreach: recruitment posters and brochures (country-specific versions: e.g., K1_ITA Recruitment Poster/Brochure, K1_Recruitment Brochure Polish/Hungarian/German) targeted at parents/guardians.
• Direct contact materials: Dear Parent/Patient letters (country-specific Dear Parent letters) distributed to potential participants/parents.
• Site-led pre-screening tools and consenting tools for site staff (pre-screening tool referenced; digital pre-screening and consent navigator materials mentioned).
• Consent navigator and parent/guardian guides (country-specific Consent Navigator and Parent Guardian Guide documents) to facilitate consent.
• Study information brochures and localised recruitment arrangements files (country-specific K1 and K2 recruitment documents for Italy, Poland, Hungary, Germany).

Italy

Latest Decision Or Authorization Date

14-08-2025

Number Of Sites

4

Number Of Participants

25

Poland

Latest Decision Or Authorization Date

07-11-2025

Number Of Sites

10

Number Of Participants

237

Hungary

Latest Decision Or Authorization Date

05-12-2025

Number Of Sites

6

Number Of Participants

140

Germany

Latest Decision Or Authorization Date

20-03-2026

Number Of Sites

7

Number Of Participants

95

Primary sponsor

Full Name

OM Pharma SA

Organisation Type

Pharmaceutical company

Country Of Registered Address

Switzerland

Contract research organisations

Name

Medidata Solutions Inc.

Responsibilities

Randomisation and trial supply management, Targeted Source Data Verification RAVE- eCRF

Name

Parexel International (IRL) Limited

Responsibilities

Sponsor duties codes: [1,10,11,12,13,2,6,7,8]

Name

Longboat Clinical Limited

Responsibilities

Pre- screening tool and consenting tools for site staff

Name

Perceptive Informatics Inc.

Responsibilities

Emergency Medical Consulting ("EMC") Services

Third parties

• {"country":"Germany","full_name":"Rickert Rechtsanwaltsgesellschaft mbH","duties_or_roles":"duties EU representative for data protection","organisation_type":"Industry"}
• {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"Randomisation and trial supply management, Targeted Source Data Verification RAVE- eCRF","organisation_type":"Non-Pharmaceutical company"}
• {"country":"United States","full_name":"Perceptive Informatics Inc.","duties_or_roles":"Emergency Medical Consulting (\"EMC\") Services","organisation_type":"Pharmaceutical company"}
• {"country":"Ireland","full_name":"Longboat Clinical Limited","duties_or_roles":"Pre- screening tool and consenting tools for site staff","organisation_type":"Non-Pharmaceutical company"}
• {"country":"United Kingdom","full_name":"Alderley Analytical Limited","duties_or_roles":"Sample storage","organisation_type":"Pharmaceutical company"}
• {"country":"France","full_name":"Alsinova Boulogne-Billancourt","duties_or_roles":"","organisation_type":"Industry"}
• {"country":"Ireland","full_name":"Parexel International (IRL) Limited","duties_or_roles":"Sponsor duties codes: [1,10,11,12,13,2,6,7,8]","organisation_type":"Pharmaceutical company"}
• {"country":"South Africa","full_name":"Synexa Life Sciences (Pty) Ltd","duties_or_roles":"","organisation_type":"Industry"}
• {"country":"France","full_name":"Eurofins Clinical Trial Supplies France","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Clario","duties_or_roles":"","organisation_type":"Industry"}
• {"country":"Netherlands","full_name":"CSE Europe B.V. (Halo)","duties_or_roles":"Retention Materials","organisation_type":"SME"}
• {"country":"United Kingdom","full_name":"Vivos Technology Limited","duties_or_roles":"","organisation_type":"Non-Pharmaceutical company"}