Child Pneumococcal Serotype Epidemiology In Greece

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01111214
First received: April 23, 2010
Last updated: January 9, 2013
Last verified: January 2013
  Purpose

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.


Condition Intervention
Pneumococcal Disease
Other: no intervention

Study Type: Observational
Study Design: Time Perspective: Retrospective
Official Title: Incidence And Serotypes Of Invasive Pneumococcal Disease, After The Introduction Of The Heptavalent Conjugated Vaccine In Greece

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Serotype distribution of resistant S. pneumoniae isolates [ Time Frame: yearly ] [ Designated as safety issue: No ]
  • Serotype distribution of IPD between immunized and non immunized children ≤14 years of age [ Time Frame: yearly ] [ Designated as safety issue: No ]
  • Antimicrobial susceptibilities of IPD isolates and rates of resistance to penicillin [ Time Frame: yearly ] [ Designated as safety issue: No ]

Enrollment: 457
Study Start Date: November 2011
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   up to 14 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Hospitalized children in participating centers

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01111214

Locations
Greece
Agia Sophia Children's Hospital
Athens, Attiki, Greece, 115 27
University Hospital of Alexandroupolis
Alexandroupoli, Greece, 68100
Venizeleion General Hospital of Herakleion
Herakleion, Greece, 71409
University Hospital of Herakleion
Herakleion, Greece, 70013
University Hospital of Ioannina
Ioannina, Greece, 45332
University of Thessaly School of Medicine
Larissa, Greece, 415 00
Ahepa Hospital Paediatric Outpatient Special Clinic 1st Kyri
Thessaloniki, Greece, 54636
Ippokrateion Peripheral Hospital of Thessaloniki
Thessaloniki, Greece, 54642
Peripheral Hospital of Trikala
Trikala, Greece, 42100
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01111214     History of Changes
Other Study ID Numbers: 0887X1-4434, B1841010
Study First Received: April 23, 2010
Last Updated: January 9, 2013
Health Authority: Greece: National Organization for Medicines

Keywords provided by Pfizer:
Invasive Pneumococcal Disease (IPD)
pneumococcal serotypes

ClinicalTrials.gov processed this record on July 22, 2014