Respiratory Tract InfectionsPhase 4NCT05677763
OM-85 in Paediatric Recurrent Respiratory Tract Infections With Wheezing Lower Respiratory Illness
A Phase 4 study testing OM-85 in people with Respiratory Tract Infections and Wheezing Lower Respiratory Illness, run by OM Pharma SA at 42 sites in 6 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 6 months to 5 years
- Conditions the study is for
- Respiratory Tract Infections, Wheezing Lower Respiratory Illness
- What is being tested?
- OM-85
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 525 participants
- Where
- 42 sitesin 6 countries
- Study dates
- 12 Dec 2022to 16 Sep 2026
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 22Show fewer
- 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:
- Injection or oral administration of steroids 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.
- Wheezing documented to be caused by gastroesophageal reflux.
Trial locations and contacts
42 sites in 6 countries.
42 sites in 6 countries
Poland12 sites
NZOZ E-Vita
Bialystok, Podlaskie Voivodeship, 15-879
Centrum Medyczne Pratia Czestochowa
Częstochowa, Silesian Voivodeship, 42-217
Malopolskie Centrum Alergologii
Krakow, Lesser Poland Voivodeship, 31-624
Centrum Medyczne PROMED
Krakow, 31-411
WWCOiT im. M. Kopernika w Lodzi, Osrodek Pediatryczny im. dr J.Korczaka
Lodz, Lódzkie, 90-329
Centrum Alergologii Specjalistyczna Przychodnia Alergologiczna
Lublin, Lublin Voivodeship, 20-552
Podkarpacki Osrodek Pulmonologii i Alergologii Sp. z o.o.
Rzeszów, 35-612
NZLA Michalkowice - Jarosz i Partnerzy Spolka Lekarska
Siemianowice Śląskie, Silesian Voivodeship, 41-103
NSZOZ Puls - Med Anna Bogusz, Agnieszka Musielak Sp.J.
Skarżysko-Kamienna, Świętokrzyskie Voivodeship, 26-110
Velocity Skierniewice Sp. z o.o.
Skierniewice, 96-100
ALERGO-MED Specjalistyczna Przychodnia Lekarska Spolka z o.o.
Tarnów, Lesser Poland Voivodeship, 33-100
Przychodnia Specjalistyczna Prosen-Med NZOZ
Warsaw, 01-231
Germany9 sites
St. Josef-Hospital
Bochum, North Rhine-Westphalia, 44791
University Hospital Cologne AöR
Cologne, North Rhine-Westphalia, 50937
Ev. Krankenhaus Düsseldorf
Düsseldorf, North Rhine-Westphalia, 40217
Medizinische Hochschule Hannover
Hanover, Lower Saxony, 30625
Universitätsklinikum Schleswig-Holstein Campus Lübeck
Lübeck, Schleswig-Holstein, 23538
Praxis Köllges
Mönchengladbach, North Rhine-Westphalia, 41236
Ludwig Maximilians Universität München
München, Bavaria, 80337
Clinical Research & Healthcare GmbH
Schönau am Königssee, Bavaria, 83471
Marien-Hospital Wesel gGmbH
Wesel, North Rhine-Westphalia, 46483
Hungary6 sites
Dr. Kenessey Albert Korhaz-Rendelointezet
Balassagyarmat, H-2660
Semmelweis Egyetem I.sz. Gyermekgyogyaszati Klinika
Budapest, 1083
Heim Pal Orszagos Gyermekgyogyaszati Intezet
Budapest, 1089
Sanitas Diagnosztikai és Rehabilitációs Központ
Gyula, 5700
Futurenest Kft.
Miskolc, 3527
Aranyklinika Kft
Szeged, Csongrád megye, 6720
United Kingdom6 sites
Brighton And Sussex University Hospitals NHS Trust
Brighton, East Sussex, BN2 5BE
Royal Hospital for Children and Young People
Edinburgh, EH9 1LF
Royal London Hospital
London, E1 4NS
King's College Hospital
London, SE5 9RS
Royal Manchester Children's Hospital - Paediatrics - Paediatrics
Manchester, Manchester, M13 9WL
Nottingham University Hospitals NHS Trust - Queen's Medical Centre
Nottingham, Nottingham, NG7 2UH
Italy5 sites
Osp.Pediatr.Giov.XXIII,AOUC P.Bari
Bari, 70126
ASST Papa GiovanniXXIII,Mat.Inf.Ped
Bergamo, 24127
Azienda ospedalo universitaria
Parma, Parma, 43100
Universita degli Studi di Pavia - Fondazione IRCCS Policlini
Pavia, Pavia, 27100
SO S.Chiara, AOU Pisana
Pisa, Pisa, 56126
Switzerland4 sites
Inselspital Bern Kinderklinik
Bern, Canton of Bern, 3010
Hôpitaux Universitaires de Genève (HUG)
Geneva, 1205
CHUV-Centre Hopitalier Universitaire Vaudois
Lausanne, Canton of Vaud, 1011
Universitaets-Kinderklinik - Kinderspital Zuerich
Zurich, 8032
About this study
Official title: 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.
Read the detailed description
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).
- Being tested
- OM-85, Placebo
- Medical subject headings
- Respiratory Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OM-85Drug
Subjects will be administered OM-85 3.5 mg capsules by mouth once daily. (10 days per month)
PlaceboDrug
Subjects will be administered Placebo once daily. (10 days per month)
| Study group | Role | What they receive |
|---|---|---|
| BV-12 | Experimental | Subjects will receive OM-85 treatment for 12 consecutive months. (10 days per month) Receives: Drug: OM-85 |
| BV-3 | Experimental | Subjects will receive OM-85 treatment for 3 consecutive months, followed by matching placebo for 9 consecutive months. (10 days per month) Receives: Drug: OM-85 |
| Placebo | Placebo comparator | Subjects will receive matching placebo for 12 consecutive months. (10 days per month) Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of respiratory tract infections (RTIs)
The number of RTIs experienced by a subject during the Treatment period will be assessed.
Measured: 12 Months
Secondary outcomes (24)
Rate of wheezing lower respiratory infections (wLRIs) experienced by a subject
The number of wLRIs experienced by a subject during the Treatment period will be assessed. This is the key secondary endpoint
Measured: 12 Months
Rate of wLRIs
The number of wLRIs experienced by a subject during the Treatment period, during the Observational period, and during the whole study period will be assessed.
Measured: 18 Months
Rate of respiratory tract infections (RTIs)
The number of RTIs experienced by a subject during the Treatment period, during the Observational period, and during the whole study period will be assessed.
Measured: 18 Months
Proportion of subjects with recurrent RTIs
The proportion of subjects experiencing ≥3 RTIs during the first 6 months of Treatment period, the proportion of subjects experiencing ≥4 RTIs during the full 12-month Treatment period and the proportion of subjects experiencing ≥6 RTIs during the full 12-month Treatment period and during the whole study period will be assessed.
Measured: 18 Months
Proportion of subjects with wLRIs
The proportion of subjects with wLRIs during the Treatment period, during the Observational period, and during the whole study period will be assessed.
Measured: 18 Months
Rate of severe wheezing lower respiratory illness (SwLRIs)
The number of SwLRIs experienced by a subject during the Treatment period, during the Observational period, and during the whole study period will be assessed.
Measured: 18 Months
Proportion of subjects with SwLRIs
The proportion of subjects with SwLRIs during the Treatment period, during the Observational period, and during the whole study period will be assessed.
Measured: 18 Months
Time to first, second and third RTI and wLRI
Time to first, second and third RTI and wLRI during the whole study period will be assessed.
Measured: 18 Months
Mean duration in days per RTI and acute RTI
Mean duration in days per RTI and mean duration in days per acute RTI during the Treatment period, during the Observational period, and during the whole study period will be assessed.
Measured: 18 Months
Mean duration in days per wLRI
Mean duration in days per wLRI during the Treatment period, during the Observational period, and during the whole study period will be assessed.
Measured: 18 Months
Mean duration in days per SwLRI
Mean duration in days per SwLRI during the Treatment period, during the Observational period, and during the whole study period will be assessed.
Measured: 18 months
Number of healthcare resource utilisations
Number of healthcare resource utilisations (inpatient hospitalisations, visits to emergency rooms, or to a physician/health care provider) due to an RTI and/or a wLRI during the Treatment period, during the Observational period, and during the whole study period will be assessed.
Measured: 18 Months
Number of absent days from daycare
Number of absent days from daycare due to an RTI and/or a wLRI during the Treatment period, during the Observational period, and during the whole study period will be assessed.
Measured: 18 Months
Number of antibiotic treatments for a respiratory event
Number of antibiotic treatments for a respiratory event during the Treatment period, during the Observational period, and during the whole study period will be assessed.
Measured: 18 Months
Duration of antibiotic treatments for a respiratory event
Duration of antibiotic treatments for a respiratory event during the Treatment period, during the Observational period, and during the whole study period will be assessed.
Measured: 18 Months
Number of systemic corticosteroids, inhaled corticosteroids (ICS) and β2-agonist treatments for a wLRI
Number of systemic corticosteroids, ICS and β2-agonist treatments for a wLRI during the Treatment period, during the Observational period, and during the whole study period will be assessed.
Measured: 18 Months
Duration of systemic corticosteroids, ICS and β2-agonist treatments for a wLRI
Duration of systemic corticosteroids, ICS and β2-agonist treatments for a wLRI during the Treatment period, during the Observational period, and during the whole study period will be assessed.
Measured: 18 Months
Symptom duration as per the adapted Wisconsin Upper Respiratory Symptom Survey for Kids (WURSS-K) questionnaire
Symptom duration during the Treatment period, during the Observational period, and during the whole study period will be assessed using WURSS-K questionnaire. Adapted WURSS-K is a valid and reliable illness-specific quality of life instrument that evaluates the impacts of RTIs on children.
Measured: 18 Months
Symptom types as per the adapted WURSS-K questionnaire
Symptom types during the Treatment period, during the Observational period, and during the whole study period will be assessed using WURSS-K questionnaire. Adapted WURSS is a valid and reliable illness-specific quality of life instrument that evaluates the impacts of RTIs on children.
Measured: 18 Months
Symptom severity as per the adapted WURSS-K questionnaire
Symptom severity during the Treatment period, during the Observational period, and during the whole study period will be assessed using WURSS-K questionnaire. Adapted WURSS is a valid and reliable illness-specific quality of life instrument that evaluates the impacts of RTIs on children.
Measured: 18 Months
Proportion of subjects who have not used antibiotics as rescue medication for RTI
The proportion of subjects who have not used antibiotics as rescue medication for RTI during the Treatment period, during the Observational period, and during the whole study period will be assessed.
Measured: 18 Months
Proportion of subjects who have not been hospitalised for an RTI
The proportion of subjects who have not been hospitalised for an RTI during the Treatment period, during the Observational period, and during the whole study period will be assessed.
Measured: 18 Months
Proportion of subjects who have not been administered a systemic corticosteroid for wLRI
The proportion of subjects who have not been administered a systemic corticosteroid for wLRI during the Treatment period, during the Observational period, and during the whole study period will be assessed.
Measured: 18 Months
Proportion of subjects who have not been hospitalised for more than 1 day for wLRI
The proportion of subjects who have not been hospitalised for more than 1 day for wLRI during the Treatment period, during the Observational period, and during the whole study period will be assessed.
Measured: 18 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2023
- Study start12 Dec 2022
- Primary completion10 Mar 2026
- Study completion16 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Tract InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 525 participants (actual)
Sponsor and investigators
- Lead sponsor
- OM Pharma SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05677763
- Sponsor's protocol ID
- BV-2020/08
- Other IDs
- 2024-511581-37-00
- Status last verified
- Sep 2026
- First submitted
- 14 Dec 2022
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05677763
- Acronym / sponsor ID
- BV-2020/08
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 525 participants (actual)
- Lead sponsor
- OM Pharma SAIndustry (pharma, biotech, devices)
- Study start
- 12 Dec 2022 (actual)
- Primary completion
- 10 Mar 2026 (actual)
- Study completion
- 16 Sep 2026 (actual)
- First posted
- 10 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| BV-12 | Experimental | Drug: OM-85Subjects will receive OM-85 treatment for 12 consecutive months. (10 days per month) |
| BV-3 | Experimental | Drug: OM-85Subjects will receive OM-85 treatment for 3 consecutive months, followed by matching placebo for 9 consecutive months. (10 days per month) |
| Placebo | Placebo comparator | Drug: PlaceboSubjects will receive matching placebo for 12 consecutive months. (10 days per month) |
Who may qualify
- Ages
- 6 months to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (22 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OM-85Subjects will be administered OM-85 3.5 mg capsules by mouth once daily. (10 days per month) | Drug | BV-12, BV-3 |
| PlaceboSubjects will be administered Placebo once daily. (10 days per month) | Drug | Placebo |
Primary outcome
Rate of respiratory tract infections (RTIs)
Time frame: 12 Months
The number of RTIs experienced by a subject during the Treatment period will be assessed.
24 secondary outcomes
Rate of wheezing lower respiratory infections (wLRIs) experienced by a subject
Time frame: 12 Months
Rate of wLRIs
Time frame: 18 Months
Rate of respiratory tract infections (RTIs)
Time frame: 18 Months
Proportion of subjects with recurrent RTIs
Time frame: 18 Months
Proportion of subjects with wLRIs
Time frame: 18 Months
Rate of severe wheezing lower respiratory illness (SwLRIs)
Time frame: 18 Months
Proportion of subjects with SwLRIs
Time frame: 18 Months
Time to first, second and third RTI and wLRI
Time frame: 18 Months
Mean duration in days per RTI and acute RTI
Time frame: 18 Months
Mean duration in days per wLRI
Time frame: 18 Months
Mean duration in days per SwLRI
Time frame: 18 months
Number of healthcare resource utilisations
Time frame: 18 Months
Number of absent days from daycare
Time frame: 18 Months
Number of antibiotic treatments for a respiratory event
Time frame: 18 Months
Duration of antibiotic treatments for a respiratory event
Time frame: 18 Months
Number of systemic corticosteroids, inhaled corticosteroids (ICS) and β2-agonist treatments for a wLRI
Time frame: 18 Months
Duration of systemic corticosteroids, ICS and β2-agonist treatments for a wLRI
Time frame: 18 Months
Symptom duration as per the adapted Wisconsin Upper Respiratory Symptom Survey for Kids (WURSS-K) questionnaire
Time frame: 18 Months
Symptom types as per the adapted WURSS-K questionnaire
Time frame: 18 Months
Symptom severity as per the adapted WURSS-K questionnaire
Time frame: 18 Months
Proportion of subjects who have not used antibiotics as rescue medication for RTI
Time frame: 18 Months
Proportion of subjects who have not been hospitalised for an RTI
Time frame: 18 Months
Proportion of subjects who have not been administered a systemic corticosteroid for wLRI
Time frame: 18 Months
Proportion of subjects who have not been hospitalised for more than 1 day for wLRI
Time frame: 18 Months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
- Individual participant dataSharing planned: No
Related trials for Respiratory Tract Infections
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
RecruitingObservational study
VIRal Pulmonary Infections in Older AGE
Viral Pulmonary Infections
Not yet recruitingPhase 2/3
A Pivotal Safety and Immunogenicity GBS-NN/NN2 Vaccine Maternal Immunisation Trial
Streptococcus Agalactiae Infection, Neonatal Sepsis
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
42 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing OM-85 in people with Respiratory Tract Infections and Wheezing Lower Respiratory Illness, run by OM Pharma SA at 42 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 42 sites in Poland, Germany, Hungary, United Kingdom, Italy and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of respiratory tract infections (RTIs) (time frame: 12 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2026.