Acute Otitis Media Clinical Trial
Official title:
Assessment of the Natural Antibody Response to Pneumococcal Surface Proteins During Acute Otitis Media in Children
Verified date | September 2011 |
Source | NasVax Ltd |
Contact | n/a |
Is FDA regulated | No |
Health authority | Israel: Ministry of Health |
Study type | Observational |
This clinical study is designed to assess prospectively the sero-responses to various proteins in cases of pneumococcal Acute Otitis Media.
Status | Recruiting |
Enrollment | 100 |
Est. completion date | July 2014 |
Est. primary completion date | March 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 3 Months to 3 Years |
Eligibility |
Inclusion Criteria: - 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). |
Observational Model: Case Control, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
Israel | Ben-Gurion University of the Negev | Beer Sheva |
Lead Sponsor | Collaborator |
---|---|
NasVax Ltd |
Israel,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Serological studies of pneumococcal proteins and their development over time following otitis media infections | The serological studies will study the natural immune response to protective pneumococcal vaccine antigens. | 3 months per individual | No |
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