This clinical study is designed to assess prospectively the sero-responses to various proteins in cases of pneumococcal Acute Otitis Media.
- Study Type: Observational
- Study Design
- Time Perspective: Prospective
- Study Primary Completion Date: March 2014
Arms, Groups and Cohorts
- Control group – culture negative
- 50 children with pneumococcal culture-negative Acute Otitis Media
- study group- culture positive
- 50 children with pneumococcal culture-positive Acute Otitis Media
Clinical Trial Outcome Measures
- Serological studies of pneumococcal proteins and their development over time following otitis media infections
- Time Frame: 3 months per individual
- The serological studies will study the natural immune response to protective pneumococcal vaccine antigens.
Participating in This Clinical Trial
- Male and female Jewish and Bedouin children. – Patients can be either ambulatory or hospitalized. – Presenting with acute otitis media. – Tympanocentesis was performed at least in one ear for a clinical indication. – Culture of middle ear fluid was obtained. – Parents agreeing to participate in the study and to submit their children for follow-up, blood test and nasopharyngeal/oropharyngeal (NP/OP) cultures. Exclusion Criteria:
- Having another infection that is likely to be caused by S. pneumoniae. – Known immunodeficiency. – Known previous recent pneumococcal infections (<1 month prior to current visit).
Gender Eligibility: All
Minimum Age: 3 Months
Maximum Age: 3 Years
Are Healthy Volunteers Accepted: No
- Lead Sponsor
- NasVax Ltd
- Provider of Information About this Clinical Study
- Overall Official(s)
- Ron Dagan, Prof. MD., Principal Investigator, Ben-Gurion University of the Negev
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