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

This study is currently recruiting participants.

Verified by Wyeth, December 2007

Sponsored by:	Wyeth
Information provided by:	Wyeth
ClinicalTrials.gov Identifier:	NCT00227188

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

Drug Information available for: Heptavalent pneumococcal conjugate vaccine Pneumococcal Vaccines

U.S. FDA Resources

Study Type:	Observational
Study Design:	Prospective
Official Title:	Effectiveness of Prevnar in the Prevention of Invasive Pneumococcal Disease (IPD) in the Paediatric Population in Spain.

Further study details as provided by Wyeth:

Biospecimen Retention: Samples Without DNA

Biospecimen Description:

Samples without DNA

Estimated Enrollment:	500
Study Start Date:	May 2003

Intervention Details:

Injectable

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 publica 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

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

Contacts

Contact: Trial Manager

clintrialparticipation@wyeth.com

Locations

Spain
	Recruiting
Alava, Spain
	Recruiting
Bilbao, Spain
	Recruiting
Pamplona, Spain
	Recruiting
San Sebastián, Spain
	Recruiting
Vitoria, Spain

Sponsors and Collaborators

Wyeth

Investigators

Study Director:

Medical Monitor

Wyeth

More Information

Responsible Party:	Wyeth ( Wyeth (Registry Contact: Clinical Trial Registry Specialist) )
Study ID Numbers:	0887-101317
Study First Received:	September 13, 2005
Last Updated:	December 21, 2007
ClinicalTrials.gov Identifier:	NCT00227188
Health Authority:	Spain: Spanish Agency of Medicines

ClinicalTrials.gov processed this record on January 16, 2009