Assessment of the Natural Antibody Response to Pneumococcal Surface Proteins During Acute Otitis Media in Children
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|ClinicalTrials.gov Identifier: NCT01214538|
Recruitment Status : Unknown
Verified September 2011 by NasVax Ltd.
Recruitment status was: Recruiting
First Posted : October 5, 2010
Last Update Posted : September 27, 2011
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|Condition or disease|
|Acute Otitis Media|
|Study Type :||Observational|
|Estimated Enrollment :||100 participants|
|Official Title:||Assessment of the Natural Antibody Response to Pneumococcal Surface Proteins During Acute Otitis Media in Children|
|Study Start Date :||October 2010|
|Estimated Primary Completion Date :||March 2014|
|Estimated Study Completion Date :||July 2014|
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
- 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.
Biospecimen Retention: Samples Without DNA
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|Ages Eligible for Study:||3 Months to 3 Years (Child)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
|Sampling Method:||Probability Sample|
- 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.
- 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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01214538
|Ben-Gurion University of the Negev||Recruiting|
|Beer Sheva, Israel, 84101|
|Contact: Ron Dagan, Prof MD +972 + 8-6400547 firstname.lastname@example.org|
|Principal Investigator:||Ron Dagan, Prof. MD.||Ben-Gurion University of the Negev|
|Responsible Party:||NasVax Ltd|
|Other Study ID Numbers:||
|First Posted:||October 5, 2010 Key Record Dates|
|Last Update Posted:||September 27, 2011|
|Last Verified:||September 2011|
Vaccine pneumococcal natural history Acute otitis media