Assessment of the Natural Antibody Response to Pneumococcal Surface Proteins During Acute Otitis Media in Children

This study is currently recruiting participants.
Verified September 2011 by NasVax Ltd
Sponsor:
Information provided by (Responsible Party):
NasVax Ltd
ClinicalTrials.gov Identifier:
NCT01214538
First received: October 3, 2010
Last updated: September 26, 2011
Last verified: September 2011

October 3, 2010
September 26, 2011
October 2010
March 2014   (final data collection date for primary outcome measure)
Serological studies of pneumococcal proteins and their development over time following otitis media infections [ Time Frame: 3 months per individual ] [ Designated as safety issue: No ]
The serological studies will study the natural immune response to protective pneumococcal vaccine antigens.
Serological studies of pneumococcal proteins and their development over time following otitis media infections [ Time Frame: 3 months per individual ] [ Designated as safety issue: No ]
Thus, the serological studies planned in this protocol will afford the opportunity to study the natural immune response to protective pneumococcal vaccine antigens.
Complete list of historical versions of study NCT01214538 on ClinicalTrials.gov Archive Site
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Assessment of the Natural Antibody Response to Pneumococcal Surface Proteins During Acute Otitis Media in Children
Assessment of the Natural Antibody Response to Pneumococcal Surface Proteins During Acute Otitis Media in Children

This clinical study is designed to assess prospectively the sero-responses to various proteins in cases of pneumococcal Acute Otitis Media.

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Observational
Observational Model: Case Control
Time Perspective: Prospective
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Retention:   Samples Without DNA
Description:

Plasma

Probability Sample

100 subjects with acute otitis media infection will be enrolled. The expectation is for ≥50 children with pneumococcal culture-positive MEF (Middle Ear Fluid) and ≥50 children with culture-negative MEF to be enrolled

Acute Otitis Media
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  • 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
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
July 2014
March 2014   (final data collection date for primary outcome measure)

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).
Both
3 Months to 3 Years
No
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Israel
 
NCT01214538
NX10-07
No
NasVax Ltd
NasVax Ltd
Not Provided
Principal Investigator: Ron Dagan, Prof. MD. Ben-Gurion University of the Negev
NasVax Ltd
September 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP