Child Pneumococcal Serotype Epidemiology In Greece

Completed

• Conditions: Pneumococcal Disease
• Interventions: Other: no intervention

• Registration Number: NCT01111214
• Lead Sponsor: Pfizer

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.

Detailed Description

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

Study Timeline

• Study First Submitted: 2010-04-23
• Study First Submitted QC: 2010-04-26
• Study First Posted: 2010-04-27
• Study Start: 2011-11
• Primary Completion: 2012-11
• Study Completion: 2012-11
• Status Verified: 2013-01
• Last Update Submitted: 2013-01-09
• Last Update Posted: 2013-01-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 457

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
group 1	no intervention	Hospitalized children ≤14 years of age with invasive pneumococcal disease

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

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

Trial Locations

Locations (9)

Agia Sophia Children's Hospital; 🇬🇷 Athens, Attiki, Greece

University Hospital of Alexandroupolis; 🇬🇷 Alexandroupoli, 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

Peripheral Hospital of Trikala; 🇬🇷 Trikala, Greece

Ippokrateion Peripheral Hospital of Thessaloniki; 🇬🇷 Thessaloniki, Greece