Child Pneumococcal Serotype Epidemiology In Greece

• ClinicalTrials.gov Identifier: NCT01111214
• Recruitment Status: Completed
• First Posted: April 27, 2010
• Last Update Posted: January 10, 2013
• Sponsor: Pfizer
• Information provided by (Responsible Party): Pfizer

Study Description

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 Design

• 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
• Actual Primary Completion Date: November 2012
• Actual Study Completion Date: November 2012

Groups and Cohorts

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.

Outcome Measures

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 ]

Eligibility Criteria

• 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

Criteria

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

Contacts and Locations

Locations

Greece

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

Pfizer

Investigators

• Study Director: Pfizer CT.gov Call Center; Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. 

• Responsible Party: Pfizer
• ClinicalTrials.gov Identifier: NCT01111214 History of Changes
• Other Study ID Numbers: 0887X1-4434; B1841010
• First Posted: April 27, 2010
• 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