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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:
ClinicalTrials.gov Identifier:
NCT00227188
First Posted: September 27, 2005
Last Update Posted: November 29, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Pfizer
  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

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 5 Years   (Child)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00227188     History of Changes
Other Study ID Numbers: 0887-101317
First Submitted: September 13, 2005
First Posted: September 27, 2005
Last Update Posted: November 29, 2012
Last Verified: November 2012

Additional relevant MeSH terms:
Pneumococcal Infections
Streptococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Heptavalent Pneumococcal Conjugate Vaccine
Immunologic Factors
Physiological Effects of Drugs