Study Evaluating Prevenar in the Prevention of Invasive P... | NCT00227188

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

NCT00227188

Sponsor

Pfizer

Status

Completed

Last Update Posted

Nov 29, 2012Estimated

Enrollment

408Actual

Phase

Not provided

Conditions

Invasive Pneumococcal Disease

Interventions

Pneumococcal 7-valent conjugate vaccine Prevnar

Countries

Spain

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2003

Primary Completion Date

Dec 2005Actual

Completion Date

Dec 2005Actual

First Submitted Date

Sep 13, 2005

First Submission Date that Met QC Criteria

Sep 13, 2005

First Posted Date

Sep 27, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 28, 2012

Last Update Posted Date

Nov 29, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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)

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

408Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1		Children from 0-5 years of age evaluated for IPD	Drug: Pneumococcal 7-valent conjugate vaccine Prevnar

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Pneumococcal 7-valent conjugate vaccine Prevnar	Drug		1	PREVNAR

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

5 Years

Standard Ages

Child

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Pfizer CT.gov Call Center	Pfizer	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Pfizer Investigational Site		Bilbao		48903	Spain

References Module

Citations

Not provided

ID	Term
D022242	Pneumococcal Vaccines
D022541	Streptococcal Vaccines
D001428	Bacterial Vaccines
D014612	Vaccines