Study Evaluating Prevenar in High-Risk Children | NCT00234338

Studies
Study Evaluating Prevenar in High-Risk Children

NCT00234338

Sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Status

Completed

Last Update Posted

Dec 10, 2007Estimated

Enrollment

5,000Estimated

Phase

Not provided

Conditions

Pneumococcal Disease

Interventions

Not provided

Countries

Germany

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

Dec 2007

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

Oct 2005

Primary Completion Date

Not provided

Completion Date

Apr 2007Actual

First Submitted Date

Oct 4, 2005

First Submission Date that Met QC Criteria

Oct 5, 2005

First Posted Date

Oct 6, 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

Dec 7, 2007

Last Update Posted Date

Dec 10, 2007Estimated

Description Module

Brief Summary

The purpose of this study is to estimate the local and systemic tolerability of Prevenar in children ages 2 to 5 years old in usual care settings.

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

No data available

No data is available for this block.

Enrollment

5,000Estimated

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

High-risk children ages 2 to 5 years old

Exclusion criteria:

Prior administration of Prevenar
Prior and/or concurrent administration of 23 vPs vaccine

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

2 Years

Maximum Age

5 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Medical Monitor	Wyeth is now a wholly owned subsidiary of Pfizer	Study Director
Trial Manager	For Germany, MedInfoDEU@wyeth.com	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
		Frankfurt		60590	Germany

Condition Browse Module

MeSH Terms

ID	Term
D011008	Pneumococcal Infections

Ancestor Terms

ID	Term
D013290	Streptococcal Infections
D016908	Gram-Positive Bacterial Infections
D001424	Bacterial Infections
D001423	Bacterial Infections and Mycoses

Browse Leaves

Not provided

Browse Branches

Not provided