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

NasVax

Status: Unknown

Conditions: Acute Otitis Media

Study type: Observational

Funder types: Industry

Identifiers

NCT01214538

NX10-07

Details and patient eligibility

About

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

Enrollment: 100 estimated patients

Sex: All

Ages: 3 months to 3 years old

Volunteers: No 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).

Trial design

100 participants in 2 patient groups

Control group - culture negative

Description:

50 children with pneumococcal culture-negative Acute Otitis Media

study group- culture positive

Description:

50 children with pneumococcal culture-positive Acute Otitis Media