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Study Investigating Administration of Prevenar for Post-Marketing Surveillance

Last updated on November 13, 2019

FOR MORE INFORMATION
Study Location
Seoul, , 100-380 Korea, Republic of
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Pneumococcal Infections
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
6-9 weeks
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Infants and children aged 6 weeks to 9 years, provided the conditions pertaining to
contraindications, warnings, precautions, and interactions stated in the package
insert do not apply.

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

- Hypersensitivity to latex or to any component of the vaccine, including diphtheria
toxoid

- Suffering from a current or recent febrile illness.

NCT00195390
Pfizer
Completed
Study Investigating Administration of Prevenar for Post-Marketing Surveillance

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[email protected]

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Descriptive Information
Brief TitleStudy Investigating Administration of Prevenar for Post-Marketing Surveillance
Official TitleInvestigation of Prevenar (Pneumococcal 7-Valent Conjugate Vaccine) Administration for Post-Marketing Surveillance
Brief Summary

The purpose of this study is to identify the following problems and questions with respect to the safety of Pneumococcal 7-Valent Conjugate Vaccine (Diphtheria CRM 197 Protein), Prevenar, during the post-marketing period in Korea, as required by Korea Food and Drug Administration (KFDA) regulations.

  1. Adverse reactions (especially serious adverse reactions)
  2. Incidences of adverse reactions under routine vaccine use
  3. Factors that may affect the safety of the vaccine
Detailed DescriptionNot Provided
Study TypeObservational
Study DesignObservational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up DurationNot Provided
BiospecimenNot Provided
Sampling MethodNon-Probability Sample
Study PopulationPrimary care clinic, secondary and tertiary medical centers
ConditionPneumococcal Infections
InterventionBiological: Prevenar
Prevenar 0.5ml/ Vial and PFS
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: September 13, 2005)
600
Original EnrollmentSame as current
Actual Study Completion DateJuly 2008
Primary Completion DateNot Provided
Eligibility Criteria

Inclusion Criteria:

  • Infants and children aged 6 weeks to 9 years, provided the conditions pertaining to contraindications, warnings, precautions, and interactions stated in the package insert do not apply.

Exclusion Criteria:

  • Hypersensitivity to latex or to any component of the vaccine, including diphtheria toxoid
  • Suffering from a current or recent febrile illness.
Sex/Gender
Sexes Eligible for Study:All
Ages6 Weeks to 9 Years   (Child)
Accepts Healthy VolunteersYes
ContactsContact information is only displayed when the study is recruiting subjects
Listed Location CountriesKorea, Republic of
Removed Location Countries  
 
Administrative Information
NCT NumberNCT00195390
Other Study ID Numbers0887X-101583
Has Data Monitoring CommitteeNot Provided
U.S. FDA-regulated ProductNot Provided
IPD Sharing StatementNot Provided
Responsible PartyWyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
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
PRS AccountWyeth is now a wholly owned subsidiary of Pfizer
Verification DateSeptember 2008

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]

Call Now