Child Pneumococcal Serotype Epidemiology In Greece

January 9, 2013 updated by: Pfizer

Incidence And Serotypes Of Invasive Pneumococcal Disease, After The Introduction Of The Heptavalent Conjugated Vaccine In Greece

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Observational

Enrollment (Actual)

457

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Greece
      • Alexandroupoli, Greece, 68100
        • University Hospital of Alexandroupolis
      • Herakleion, Greece, 70013
        • University Hospital of Herakleion
      • Herakleion, Greece, 71409
        • Venizeleion General Hospital of Herakleion
      • Ioannina, Greece, 45332
        • University Hospital of Ioannina
      • Larissa, Greece, 415 00
        • University of Thessaly School of Medicine
      • Thessaloniki, Greece, 54636
        • Ahepa Hospital Paediatric Outpatient Special Clinic 1st Kyri
      • Thessaloniki, Greece, 54642
        • Ippokrateion Peripheral Hospital of Thessaloniki
      • Trikala, Greece, 42100
        • Peripheral Hospital of Trikala
    • Attiki
      • Athens, Attiki, Greece, 115 27
        • Agia Sophia Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 14 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Hospitalized children in participating centers

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
group 1
Hospitalized children ≤14 years of age with invasive pneumococcal disease
Other: no intervention
There is no intervention. This is a non interventional study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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
Time Frame: yearly
yearly

Secondary Outcome Measures

Outcome Measure
Time Frame
Serotype distribution of resistant S. pneumoniae isolates
Time Frame: yearly
yearly
Serotype distribution of IPD between immunized and non immunized children ≤14 years of age
Time Frame: yearly
yearly
Antimicrobial susceptibilities of IPD isolates and rates of resistance to penicillin
Time Frame: yearly
yearly

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2011

Primary Completion (Actual)

November 1, 2012

Study Completion (Actual)

November 1, 2012

Study Registration Dates

First Submitted

April 23, 2010

First Submitted That Met QC Criteria

April 26, 2010

First Posted (Estimate)

April 27, 2010

Study Record Updates

Last Update Posted (Estimate)

January 10, 2013

Last Update Submitted That Met QC Criteria

January 9, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0887X1-4434
  • B1841010

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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