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

Last updated on December 2, 2019

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Bilbao, , 48903 Spain
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Invasive Pneumococcal Disease
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
0-5
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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.

NCT00227188
Pfizer
Completed
Study Evaluating Prevenar in the Prevention of Invasive Pneumococcal Disease (IPD) in the Paediatric Population in Spain.

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Descriptive Information
Brief TitleStudy Evaluating Prevenar in the Prevention of Invasive Pneumococcal Disease (IPD) in the Paediatric Population in Spain.
Official TitleEffectiveness of Prevnar in the Prevention on IPD in the Paediatric Population in Spain
Brief SummaryThe 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)
Detailed DescriptionNot Provided
Study TypeObservational
Study DesignTime Perspective: Prospective
Target Follow-Up DurationNot Provided
BiospecimenRetention:   Samples Without DNA
Description:
Samples without DNA
Sampling MethodNon-Probability Sample
Study PopulationAll public and private hospitals with a pediatric department belonging to one of the two autonomous communities.
ConditionInvasive Pneumococcal Disease
InterventionDrug: Pneumococcal 7-valent conjugate vaccine Prevnar
Other Name: PREVNAR
Study Groups/Cohorts1
Children from 0-5 years of age evaluated for IPD
Intervention: Drug: Pneumococcal 7-valent conjugate vaccine Prevnar
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 StatusCompleted
Actual Enrollment
 (submitted: November 28, 2012)
408
Original Enrollment
 (submitted: September 13, 2005)
500
Actual Study Completion DateDecember 2005
Actual Primary Completion DateDecember 2005   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study:All
Agesup to 5 Years   (Child)
Accepts Healthy VolunteersNo
ContactsContact information is only displayed when the study is recruiting subjects
Listed Location CountriesSpain
Removed Location Countries  
 
Administrative Information
NCT NumberNCT00227188
Other Study ID Numbers0887-101317
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing StatementNot Provided
Responsible PartyPfizer
Study SponsorPfizer
CollaboratorsNot Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateNovember 2012

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

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