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Study Evaluating Prevenar in the Prevention of Invasive Pneumococcal Disease (IPD) in the Paediatric Population in Spain.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00227188
First received: September 13, 2005
Last updated: November 28, 2012
Last verified: November 2012
  Purpose

The aim of this study is to evaluate the postlicensure effectiveness of Prevnar in the prevention of IPD in the Spanish paediatric population (children younger than 5 years)


Condition Intervention
Invasive Pneumococcal Disease
Drug: Pneumococcal 7-valent conjugate vaccine Prevnar

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Effectiveness of Prevnar in the Prevention on IPD in the Paediatric Population in Spain

Resource links provided by NLM:


Further study details as provided by Pfizer:

Biospecimen Retention:   Samples Without DNA

Samples without DNA


Enrollment: 408
Study Start Date: May 2003
Study Completion Date: December 2005
Primary Completion Date: December 2005 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1
Children from 0-5 years of age evaluated for IPD
Drug: Pneumococcal 7-valent conjugate vaccine Prevnar
Other Name: PREVNAR

  Eligibility

Ages Eligible for Study:   up to 5 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

All public and private hospitals with a pediatric department belonging to one of the two autonomous communities.

Criteria

Inclusion Criteria:

  • All children from 0 up to 5 years attending to the hospital's emergency department will be evaluated for IPD.
  • Diagnosis of IPD will be based on positive pneumococcal isolation in any sterile location, such us blood or spinal fluid.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00227188

Locations
Spain
Pfizer Investigational Site
Bilbao, Spain, 48903
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00227188     History of Changes
Other Study ID Numbers: 0887-101317
Study First Received: September 13, 2005
Last Updated: November 28, 2012
Health Authority: Spain: Comité Ético de Investigación Clínica

ClinicalTrials.gov processed this record on November 27, 2014