Child Pneumococcal Serotype Epidemiology In Greece

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01111214
Recruitment Status : Completed
First Posted : April 27, 2010
Last Update Posted : January 10, 2013
Information provided by (Responsible Party):

Brief 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.

Condition or disease Intervention/treatment
Pneumococcal Disease Other: no intervention

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

Study Type : Observational
Actual Enrollment : 457 participants
Time Perspective: Retrospective
Official Title: Incidence And Serotypes Of Invasive Pneumococcal Disease, After The Introduction Of The Heptavalent Conjugated Vaccine In Greece
Study Start Date : November 2011
Primary Completion Date : November 2012
Study Completion Date : November 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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.

Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Serotype distribution of resistant S. pneumoniae isolates [ Time Frame: yearly ]
  2. Serotype distribution of IPD between immunized and non immunized children ≤14 years of age [ Time Frame: yearly ]
  3. Antimicrobial susceptibilities of IPD isolates and rates of resistance to penicillin [ Time Frame: yearly ]

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 14 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Hospitalized children in participating centers

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01111214

Agia Sophia Children's Hospital
Athens, Attiki, Greece, 115 27
University Hospital of Alexandroupolis
Alexandroupoli, Greece, 68100
University Hospital of Herakleion
Herakleion, Greece, 70013
Venizeleion General Hospital of Herakleion
Herakleion, Greece, 71409
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
Study Director: Pfizer Call Center Pfizer

Additional Information:
Responsible Party: Pfizer Identifier: NCT01111214     History of Changes
Other Study ID Numbers: 0887X1-4434
First Posted: April 27, 2010    Key Record Dates
Last Update Posted: January 10, 2013
Last Verified: January 2013

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

Additional relevant MeSH terms:
Pneumococcal Infections
Streptococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections