We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Try the New Site
We're building a modernized ClinicalTrials.gov! Visit Beta.ClinicalTrials.gov to try the new functionality.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
This clinical study is designed to assess prospectively the sero-responses to various proteins in cases of pneumococcal Acute Otitis Media.

Condition or disease
Acute Otitis Media

Study Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Case-Control
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ear Infections

Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort
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


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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
Plasma

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   3 Months to 3 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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).
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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


Locations
Layout table for location information
Israel
Ben-Gurion University of the Negev Recruiting
Beer Sheva, Israel, 84101
Contact: Ron Dagan, Prof MD    +972 + 8-6400547    rdagan@bgu.ac.il   
Sponsors and Collaborators
NasVax Ltd
Investigators
Layout table for investigator information
Principal Investigator: Ron Dagan, Prof. MD. Ben-Gurion University of the Negev
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: NasVax Ltd
ClinicalTrials.gov Identifier: NCT01214538    
Other Study ID Numbers: NX10-07
First Posted: October 5, 2010    Key Record Dates
Last Update Posted: September 27, 2011
Last Verified: September 2011
Keywords provided by NasVax Ltd:
Vaccine pneumococcal natural history Acute otitis media
Additional relevant MeSH terms:
Layout table for MeSH terms
Otitis
Otitis Media
Ear Diseases
Otorhinolaryngologic Diseases