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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2011 by NasVax Ltd.
Recruitment status was  Recruiting
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
  Purpose

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


Condition
Acute Otitis Media

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by NasVax Ltd:

Primary Outcome Measures:
  • 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.


Biospecimen Retention:   Samples Without DNA

Plasma


Estimated Enrollment: 100
Study Start Date: October 2010
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
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

  Eligibility

Ages Eligible for Study:   3 Months to 3 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01214538

Locations
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
Principal Investigator: Ron Dagan, Prof. MD. Ben-Gurion University of the Negev
  More Information

No publications provided

Responsible Party: NasVax Ltd
ClinicalTrials.gov Identifier: NCT01214538     History of Changes
Other Study ID Numbers: NX10-07
Study First Received: October 3, 2010
Last Updated: September 26, 2011
Health Authority: Israel: Ministry of Health

Keywords provided by NasVax Ltd:
Vaccine pneumococcal natural history Acute otitis media

Additional relevant MeSH terms:
Otitis
Otitis Media
Ear Diseases
Otorhinolaryngologic Diseases

ClinicalTrials.gov processed this record on September 11, 2014