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Study Evaluating Prevenar in High-Risk Children

Last updated on November 14, 2019

FOR MORE INFORMATION
Study Location
Frankfurt, , 60590 Germany
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Pneumococcal Disease
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
2-5 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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- High-risk children ages 2 to 5 years old

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
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- Prior administration of Prevenar

- Prior and/or concurrent administration of 23 vPs vaccine

NCT00234338
Pfizer
Completed
Study Evaluating Prevenar in High-Risk Children

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Descriptive Information
Brief TitleStudy Evaluating Prevenar in High-Risk Children
Official TitleProspective Post-Marketing Surveillance Study of Prevenar in High-Risk Children Aged 2 to 5 Years
Brief SummaryThe 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 DescriptionNot Provided
Study TypeObservational
Study DesignTime Perspective: Prospective
Target Follow-Up DurationNot Provided
BiospecimenNot Provided
Sampling MethodNot Provided
Study PopulationNot Provided
ConditionPneumococcal Disease
InterventionNot Provided
Study Groups/CohortsNot Provided
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
Estimated Enrollment
 (submitted: October 5, 2005)
5000
Original EnrollmentSame as current
Actual Study Completion DateApril 2007
Primary Completion DateNot Provided
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
Sex/Gender
Sexes Eligible for Study:All
Ages2 Years to 5 Years   (Child)
Accepts Healthy VolunteersYes
ContactsContact information is only displayed when the study is recruiting subjects
Listed Location CountriesGermany
Removed Location Countries  
 
Administrative Information
NCT NumberNCT00234338
Other Study ID Numbers101850
Has Data Monitoring CommitteeNot Provided
U.S. FDA-regulated ProductNot Provided
IPD Sharing StatementNot Provided
Responsible PartyNot Provided
Study SponsorWyeth is now a wholly owned subsidiary of Pfizer
CollaboratorsNot Provided
Investigators
Study Director:Medical MonitorWyeth is now a wholly owned subsidiary of Pfizer
Principal Investigator:Trial ManagerFor Germany, [email protected]
PRS AccountWyeth is now a wholly owned subsidiary of Pfizer
Verification DateDecember 2007

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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