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NCT01214538 Clinical Trial

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

Acute Otitis Media Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT01214538
Other study ID # NX10-07
Secondary ID
Status Recruiting
Phase N/A
First received October 3, 2010
Last updated September 26, 2011
Start date October 2010
Est. completion date July 2014

Study information
Verified date September 2011
Source NasVax Ltd
Contact n/a
Is FDA regulated No
Health authority Israel: Ministry of Health
Study type Observational

Clinical Trial Summary

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

Recruitment information / eligibility
Status Recruiting
Enrollment 100
Est. completion date July 2014
Est. primary completion date March 2014
Accepts healthy volunteers No
Gender Both
Age group 3 Months to 3 Years
Eligibility 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

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
Israel Ben-Gurion University of the Negev Beer Sheva

Sponsors (1)
Lead Sponsor Collaborator
NasVax Ltd

Country where clinical trial is conducted

Israel, 

Outcome
Type Measure Description Time frame Safety issue
Primary Serological studies of pneumococcal proteins and their development over time following otitis media infections The serological studies will study the natural immune response to protective pneumococcal vaccine antigens. 3 months per individual No
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