Child Pneumococcal Serotype Epidemiology In Greece

NCT ID: NCT01111214

Last Updated: 2013-01-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

457 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-11-30

Study Completion Date

2012-11-30

Brief Summary

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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

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

Conditions

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Pneumococcal Disease

Study Design

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Study Time Perspective

RETROSPECTIVE

Study Groups

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group 1

Hospitalized children ≤14 years of age with invasive pneumococcal disease

no intervention

Intervention Type OTHER

There is no intervention. This is a non interventional study.

Interventions

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no intervention

There is no intervention. This is a non interventional study.

Intervention Type OTHER

Eligibility Criteria

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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
Maximum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Agia Sophia Children's Hospital

Athens, Attica, Greece

Site Status

University Hospital of Herakleion

Heraklion, Herakleion, Greece

Site Status

Venizeleion General Hospital of Herakleion

Heraklion, Herakleion, Greece

Site Status

University Hospital of Ioannina

Ioannina, Ioannina, Greece

Site Status

Ahepa Hospital Paediatric Outpatient Special Clinic 1st Kyri

Thessaloniki, Thessaloniki, Greece

Site Status

Ippokrateion Peripheral Hospital of Thessaloniki

Thessaloniki, Thessaloniki, Greece

Site Status

Peripheral Hospital of Trikala

Trikala, Trikala, Greece

Site Status

University Hospital of Alexandroupolis

Alexandroupoli, , Greece

Site Status

University of Thessaly School of Medicine

Larissa, , Greece

Site Status

Countries

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Greece

Related Links

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Other Identifiers

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B1841010

Identifier Type: -

Identifier Source: secondary_id

0887X1-4434

Identifier Type: -

Identifier Source: org_study_id

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