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Trial record 1 of 1 for:    NCT01111214
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Child Pneumococcal Serotype Epidemiology In Greece

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

Tracking Information
First Submitted Date April 23, 2010
First Posted Date April 27, 2010
Last Update Posted Date January 10, 2013
Study Start Date November 2011
Actual Primary Completion Date November 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 3, 2011)
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 ]
Original Primary Outcome Measures
 (submitted: April 26, 2010)
The serotype distribution of invasive S. pneumoniae isolates after the introduction of the 7-valent conjugate pneumococcal vaccine
Change History Complete list of historical versions of study NCT01111214 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: June 3, 2011)
  • Serotype distribution of resistant S. pneumoniae isolates [ Time Frame: yearly ]
  • Serotype distribution of IPD between immunized and non immunized children ≤14 years of age [ Time Frame: yearly ]
  • Antimicrobial susceptibilities of IPD isolates and rates of resistance to penicillin [ Time Frame: yearly ]
Original Secondary Outcome Measures
 (submitted: April 26, 2010)
The population-based incidence of invasive pneumococcal disease (IPD) - defined as a pneumococcal infection, developing in a normally sterile body site, in children aged 10 years old or less - after the introduction of the 7-valent vaccine
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Child Pneumococcal Serotype Epidemiology In Greece
Official Title Incidence And Serotypes Of Invasive Pneumococcal Disease, After The Introduction Of The Heptavalent Conjugated Vaccine In Greece
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 Type Observational
Study Design Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Hospitalized children in participating centers
Condition Pneumococcal Disease
Intervention Other: no intervention
There is no intervention. This is a non interventional study.
Study Groups/Cohorts group 1
Hospitalized children ≤14 years of age with invasive pneumococcal disease
Intervention: Other: no intervention
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: December 20, 2012)
457
Original Estimated Enrollment
 (submitted: April 26, 2010)
300
Actual Study Completion Date November 2012
Actual Primary Completion Date November 2012   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages up to 14 Years   (Child)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Greece
Removed Location Countries  
 
Administrative Information
NCT Number NCT01111214
Other Study ID Numbers 0887X1-4434
B1841010
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Pfizer
Study Sponsor Pfizer
Collaborators Not Provided
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date January 2013