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Child Pneumococcal Serotype Epidemiology In Greece

Information source: Pfizer
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Pneumococcal Disease

Intervention: no intervention (Other)

Phase: N/A

Status: Completed

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

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.

Clinical Details

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

Study design: Time Perspective: Retrospective

Primary outcome: 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

Secondary outcome:

Serotype distribution of resistant S. pneumoniae isolates

Serotype distribution of IPD between immunized and non immunized children ≤14 years of age

Antimicrobial susceptibilities of IPD isolates and rates of resistance to penicillin

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

Eligibility

Minimum age: N/A. Maximum age: 14 Years. Gender(s): Both.

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

Locations and Contacts

University Hospital of Alexandroupolis, Alexandroupoli 68100, Greece

University Hospital of Herakleion, Herakleion 70013, Greece

Venizeleion General Hospital of Herakleion, Herakleion 71409, Greece

University Hospital of Ioannina, Ioannina 45332, Greece

University of Thessaly School of Medicine, Larissa 415 00, Greece

Ahepa Hospital Paediatric Outpatient Special Clinic 1st Kyri, Thessaloniki 54636, Greece

Ippokrateion Peripheral Hospital of Thessaloniki, Thessaloniki 54642, Greece

Peripheral Hospital of Trikala, Trikala 42100, Greece

Agia Sophia Children's Hospital, Athens, Attiki 115 27, Greece

Additional Information

To obtain contact information for a study center near you, click here.

Starting date: November 2011
Last updated: January 9, 2013

Page last updated: August 23, 2015

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