Child Pneumococcal Serotype Epidemiology In Greece

Overview

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.

Full Title of Study: “Incidence And Serotypes Of Invasive Pneumococcal Disease, After The Introduction Of The Heptavalent Conjugated Vaccine In Greece”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Retrospective
  • Study Primary Completion Date: November 2012

Detailed Description

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

Interventions

  • Other: no intervention
    • There is no intervention. This is a non interventional study.

Arms, Groups and Cohorts

  • group 1
    • Hospitalized children ≤14 years of age with invasive pneumococcal disease

Clinical Trial Outcome Measures

Primary Measures

  • 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

Secondary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: 14 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Pfizer
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Pfizer CT.gov Call Center, Study Director, Pfizer

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