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

• Conditions: Acute Otitis Media

• Registration Number: NCT01214538
• Lead Sponsor: NasVax Ltd

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 available

Study Timeline

• Study Start: 2010-10
• Study First Submitted: 2010-10-03
• Study First Submitted QC: 2010-10-04
• Study First Posted: 2010-10-05
• Status Verified: 2011-09
• Last Update Submitted: 2011-09-26
• Last Update Posted: 2011-09-27
• Primary Completion: 2014-03
• Study Completion: 2014-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Serological studies of pneumococcal proteins and their development over time following otitis media infections	3 months per individual	The serological studies will study the natural immune response to protective pneumococcal vaccine antigens.

Trial Locations

Locations (1)

Ben-Gurion University of the Negev; 🇮🇱 Beer Sheva, Israel