A study to estimate the incidence of acute otitis media and feasibility of a clinical trial in children less than 3 years of age

Children between 4 MOA and 3 YOA at the time of enrollment (Visit 1) applicable to only for Participants in the Prospective cohort (Option B) & Cross-sectional cohort.

• Participants at enrollment should be 4 months to <= 2 YOA) applicable to only for Participants in Prospective cohort (Option A).
• Participants’ parent(s)/LAR(s), who, in the opinion of the investigator, can and will comply with the requirements of the protocol (e.g., responding to a telephone call, return for follow-up visits)
• Written or witnessed/thumb printed informed consent obtained from the parent(s)/LAR(s) of the participant prior to performance of any study-specific procedure.
• Participants’ parent(s)/LAR(s) need to have access to a consistent means of TC (e.g., landline or mobile) or contact by other means (e.g., short message service, email)
• Participants with S-AOM or C-AOM according to case definitions applicable to only for Participants in the Prospective cohort (Option B) & Cross-sectional cohort.

Past or current utilization of middle ear ventilatory tubes (tympanostomy tubes)

• Past or current history of medical interventions in the middle ear
• Hypersensitivity to latex
• Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required)
• Any conditions that the investigator judges may interfere with trial procedures (e.g., contraindications to tympanocentesis)
• Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the participant due to participation in the study
• Individuals with symptoms of upper respiratory infection: fever, coryza (stuffy nose, runny nose, sneezing, and post-nasal drip, cough, conjunctivitis) within 14 days prior enrolment) applicable only to Participants in Prospective cohort (Option A)
• Administration of prescribed or non-prescribed antibiotics in the last 14 days before enrolment (applicable only to Participants in Prospective cohort (Option A))
• Children that are immediate dependents or part of the household of a study personnel.
• Planned move to a location that will prohibit participating in the study until study completion by participant
• Child in care.
• Concurrently participating in another clinical study, at any time during the study period, in which the participant has been or will be exposed to an investigational or a non-investigational intervention (e.g., drug, invasive medical device)