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Child Pneumococcal Serotype Epidemiology In Greece

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01111214
Enrollment
457
Registered
2010-04-27
Start date
2011-11-30
Completion date
2012-11-30
Last updated
2013-01-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pneumococcal Disease

Keywords

Invasive Pneumococcal Disease (IPD), pneumococcal serotypes

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

Interventions

OTHERno intervention

There is no intervention. This is a non interventional study.

Sponsors

Pfizer
Lead SponsorINDUSTRY

Study design

Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
No minimum to 14 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
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 vaccineyearly

Secondary

MeasureTime frame
Serotype distribution of resistant S. pneumoniae isolatesyearly
Serotype distribution of IPD between immunized and non immunized children ≤14 years of ageyearly
Antimicrobial susceptibilities of IPD isolates and rates of resistance to penicillinyearly

Countries

Greece

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026