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 isolatesSerotype 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
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