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

Overview

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

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: March 2014

Arms, Groups and 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

Clinical Trial Outcome Measures

Primary Measures

  • 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.

Participating in This Clinical Trial

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).

Gender Eligibility: All

Minimum Age: 3 Months

Maximum Age: 3 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • NasVax Ltd
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Ron Dagan, Prof. MD., Principal Investigator, Ben-Gurion University of the Negev

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