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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01214538

Enrollment

100

Registered

2010-10-05

Start date

2010-10-31

Completion date

2014-07-31

Last updated

2011-09-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Otitis Media

Keywords

Vaccine pneumococcal natural history Acute otitis media

Brief summary

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

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

3 Months to 3 Years

Healthy volunteers

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).

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

Israel

Outcome results