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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.

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT04946084). StuddyBuddy aggregates publicly available trial information.