Child Pneumococcal Serotype Epidemiology In Greece

Pneumococcal Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01111214
• Other study ID #: 0887X1-4434
• Secondary ID: B1841010
• Status: Completed
• Phase: N/A
• First received: April 23, 2010
• Last updated: January 9, 2013
• Start date: November 2011
• Est. completion date: November 2012

Study information

• Verified date: January 2013
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Greece: National Organization for Medicines
• Study type: Observational

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 457
• Est. completion date: November 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 14 Years

Eligibility

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

Study Design

Time Perspective: Retrospective

Related Conditions & MeSH terms

• Pneumococcal Disease

Intervention

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

Locations

Country	Name	City	State
Greece	University Hospital of Alexandroupolis	Alexandroupoli
Greece	Agia Sophia Children's Hospital	Athens	Attiki
Greece	University Hospital of Herakleion	Herakleion
Greece	Venizeleion General Hospital of Herakleion	Herakleion
Greece	University Hospital of Ioannina	Ioannina
Greece	University of Thessaly School of Medicine	Larissa
Greece	Ahepa Hospital Paediatric Outpatient Special Clinic 1st Kyri	Thessaloniki
Greece	Ippokrateion Peripheral Hospital of Thessaloniki	Thessaloniki
Greece	Peripheral Hospital of Trikala	Trikala

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		yearly	No
Secondary	Serotype distribution of resistant S. pneumoniae isolates		yearly	No
Secondary	Serotype distribution of IPD between immunized and non immunized children =14 years of age		yearly	No
Secondary	Antimicrobial susceptibilities of IPD isolates and rates of resistance to penicillin		yearly	No

External Links

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