Assessment of the Natural Antibody Response to Pneumococc... | NCT01214538

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

NCT01214538

Sponsor

NasVax Ltd

Status

Unknown status

Last Update Posted

Sep 27, 2011Estimated

Enrollment

100Estimated

Phase

Not provided

Conditions

Acute Otitis Media

Interventions

Not provided

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2011

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2010

Primary Completion Date

Mar 2014Estimated

Completion Date

Jul 2014Estimated

First Submitted Date

Oct 3, 2010

First Submission Date that Met QC Criteria

Oct 4, 2010

First Posted Date

Oct 5, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 26, 2011

Last Update Posted Date

Sep 27, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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).

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

3 Months

Maximum Age

3 Years

Standard Ages

Child

Study Population

100 subjects with acute otitis media infection will be enrolled. The expectation is for ≥50 children with pneumococcal culture-positive MEF (Middle Ear Fluid) and ≥50 children with culture-negative MEF to be enrolled

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ron Dagan, Prof. MD.	Ben-Gurion University of the Negev	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ben-Gurion University of the Negev	Recruiting	Beersheba		84101	Israel

Condition Browse Module

MeSH Terms

ID	Term
D010033	Otitis Media

Ancestor Terms

ID	Term
D010031	Otitis
D004427	Ear Diseases
D010038	Otorhinolaryngologic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided