Child Pneumococcal Serotype Epidemiology In Greece | NCT01111214

Studies
Child Pneumococcal Serotype Epidemiology In Greece

NCT01111214

Sponsor

Pfizer

Status

Completed

Last Update Posted

Jan 10, 2013Estimated

Enrollment

457Actual

Phase

Not provided

Conditions

Pneumococcal Disease

Interventions

no intervention

Countries

Greece

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

ID	Type	Description	Link
B1841010

Status Module

Record Verification Date

Jan 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2011

Primary Completion Date

Nov 2012Actual

Completion Date

Nov 2012Actual

First Submitted Date

Apr 23, 2010

First Submission Date that Met QC Criteria

Apr 26, 2010

First Posted Date

Apr 27, 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

Jan 9, 2013

Last Update Posted Date

Jan 10, 2013Estimated

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

Streptococcus pneumoniae is a major cause of pneumonia, sepsis, bacteremia, and pneumococcal meningitis among infants and children worldwide. The 7-valent conjugate pneumococcal vaccine (Prevenar) has been introduced in the Greek Market in 2004. Additionally, as of 2006 Prevenar has been included in the Greek National Immunization Program.

The effect of the mass vaccination on the incidence of pneumococcal serotypes involved in the occurring invasive pneumococcal disease, is an important factor to consider for the introduction of the 13-valent pneumococcal conjugate vaccine.

Detailed Description

open label, one group Purposive sampling of hospitalized children ≤14 years of age with confirmed IPD

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

No data available

No data is available for this block.

Enrollment

457Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
group 1		Hospitalized children ≤14 years of age with invasive pneumococcal disease	Other: no intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
no intervention	Other	There is no intervention. This is a non interventional study.	group 1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The serotype distribution of invasive S. pneumoniae isolates of hospitalized children up to 14 years of age after the introduction of the 7-valent conjugate pneumococcal vaccine		yearly

Secondary Outcomes

Measure	Description	Time Frame
Serotype distribution of resistant S. pneumoniae isolates		yearly
Serotype distribution of IPD between immunized and non immunized children ≤14 years of age		yearly

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Children aged 14 years old or less.
Hospitalized in a participating healthcare facility with an IPD.
IPD will be confirmed by isolation of S. pneumoniae from a sterile body site.

Exclusion Criteria:

Children > 14 years of age
Unconfirmed IPD

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

14 Years

Standard Ages

Child

Study Population

Hospitalized children in participating centers

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Pfizer CT.gov Call Center	Pfizer	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Agia Sophia Children's Hospital		Athens	Attica	115 27	Greece
University Hospital of Herakleion

References Module

Citations

Not provided

ID	Term
D013290	Streptococcal Infections
D016908	Gram-Positive Bacterial Infections
D001424	Bacterial Infections
D001423	Bacterial Infections and Mycoses