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OpenTrials
Completed

NCT Number: NCT01111214

Child Pneumococcal Serotype Epidemiology In Greece

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.

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Key information

Conditions

Pneumococcal Disease Bacterial Infections Bacterial Infections and Mycoses Gram-Positive Bacterial Infections Infections Pneumococcal Infections Streptococcal Infections

Age range

Up to 14 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Agia Sophia Children's Hospital, Athens, Attica, Greece

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

No intervention

Other

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Apr 27, 2010
Registry last updated
Jan 10, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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