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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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
Sponsor:
Information provided by (Responsible Party):
NasVax Ltd

Tracking Information
First Submitted Date October 3, 2010
First Posted Date October 5, 2010
Last Update Posted Date September 27, 2011
Study Start Date October 2010
Estimated Primary Completion Date March 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 5, 2010)		 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.
Original Primary Outcome Measures
 (submitted: October 4, 2010)		 Serological studies of pneumococcal proteins and their development over time following otitis media infections [ Time Frame: 3 months per individual ]
Thus, the serological studies planned in this protocol will afford the opportunity to study the natural immune response to protective pneumococcal vaccine antigens.
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Assessment of the Natural Antibody Response to Pneumococcal Surface Proteins During Acute Otitis Media in Children
Official Title Assessment of the Natural Antibody Response to Pneumococcal Surface Proteins During Acute Otitis Media in Children
Brief Summary This clinical study is designed to assess prospectively the sero-responses to various proteins in cases of pneumococcal Acute Otitis Media.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
Plasma
Sampling Method Probability Sample
Study Population 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
Condition Acute Otitis Media
Intervention Not Provided
Study Groups/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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: October 4, 2010)		 100
Original Estimated Enrollment Same as current
Estimated Study Completion Date July 2014
Estimated Primary Completion Date March 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria

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).
Sex/Gender
Sexes Eligible for Study: All
Ages 3 Months to 3 Years   (Child)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Israel
Removed Location Countries  
 
Administrative Information
NCT Number NCT01214538
Other Study ID Numbers NX10-07
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Current Responsible Party NasVax Ltd
Original Responsible Party Ronald Ellis, Md. PhD, NasVax Ltd
Current Study Sponsor NasVax Ltd
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators
Principal Investigator: Ron Dagan, Prof. MD. Ben-Gurion University of the Negev
PRS Account NasVax Ltd
Verification Date September 2011