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Active Not Recruiting
NCT04946084
Dynamic Change and Immune Response to Nasopharyngeal Carriage and Acute Otitis Media Pathogens
Conditions: Acute Otitis Media
Sex: All
Ages: 6 Months – 36 Months
Healthy volunteers: Yes
Phase: NA
Enrollment: 320
Sponsor: Rochester General Hospital
Location: Rochester General Hospital Rochester New York
Summary
The investigators seek to conduct a prospective, longitudinal study to identify the dynamic changes in nasopharyngeal (NP) colonization patterns and acute otitis media (AOM) etiology involving antibiotic-resistant Streptococcus pneumoniae (Spn) and Haemophilus influenzae (Hflu).
Eligibility Criteria
Inclusion Criteria:
* Male or female subject age 6 to 12 months + 30 days at the time of enrollment when healthy or up to 36 months old + 30 days with an ear infection.
* Subject has received full (3 dose) infant series of PCV.
* Parent/legal guardian must be able and willing to bring subject to all study visits
Exclusion Criteria:
* Any major illness/condition that, in the investigator's judgment, will substantially increase the risk associated with the subject's participation in the study.
* Participation in another investigational or interventional trial within the 28-day period before enrollment and during the conduct of the study. Participation in observational studies is permitted.
Source: ClinicalTrials.gov (NCT04946084). StuddyBuddy aggregates publicly available trial information.