Study type

Study topic

Disease /health condition
Human medicinal product

Study type

Non-interventional study

Scope of the study

Effectiveness study (incl. comparative)

Data collection methods

Secondary use of data
Non-interventional study

Non-interventional study design

Cohort
Study drug and medical condition

Medicinal product name, other

Broncho-vaxom, Ommunal, Broncho Munal, Vaxoral, Paxoral, Others.

Anatomical Therapeutic Chemical (ATC) code

(J07AX) Other bacterial vaccines
Other bacterial vaccines

Medical condition to be studied

Respiratory tract infection
Population studied

Short description of the study population

The overall study population will include patients aged ≥ 1 year of age with ≥ 1 Respiratory Tract Infection (RTI) episodes and no prescriptions of bacterial lysates within 12 months prior to the inclusion (baseline period).
Within the overall study population, patients will be categorized to one of the two exposure groups (treatment strategies): patients who initiated OM-85 at the Cohort Entry Date (CED) or within the 30-day initiation grace period, and SOC/non-user group who did not initiate OM-85 at CED or within the 30-day initiation grace period. Subgroup analysis will be considered; if conducted, several subgroups will be defined for subgroup analyses, such as patients with respiratory comorbidities, other selected comorbidities, age, and number of previous RTI episodes in the baseline period.

Age groups

  • Paediatric Population (< 18 years)
  • Adult and elderly population (≥18 years)
Study design details

Main study objective

The primary objectives are:
• Primary objective 1: RTI rate 12 months before and 12 and 24 months after initiating OM-85: To describe and compare the rate of RTI episodes 12 months before initiating preventive treatment with OM-85 and 12 and 24 months after the initiation.
• Primary objective 2: Comparative effectiveness – rate of RTI episodes during follow-up at 12 and 24 months: To compare the rate of RTI episodes during the follow-up at 12 and 24 months, in patients initiating preventive treatment with OM-85 and in comparable patients not initiating OM-85 (Standard Of Care/non-user group).

Outcomes

The primary outcome is the rate of RTI episodes.

The secondary and exploratory outcomes are:
- Baseline characteristics (age, sex, Body Mass Index, etc)
- Type and number of previous RTI episodes
- Prescription (dose, pattern of prescribing) of selected comedications, antibiotics
- Comorbidities
- Overall and RTI-specific healthcare resource utilization
- Acute exacerbations of Chronic Obstructive Pulmonary Disease (COPD)/ Chronic Bronchitis (CB) and asthma
- Time from Cohort entry date to first exacerbation of COPD/ CB and asthma