Study Investigating Administration of Prevenar for Post-Marketing Surveillance

NCT00195390

Last updated date
Study Location
Seoul, , 100-380, Korea, Republic of
Contact
1-800-718-1021

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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.

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Advanced Information
Descriptive Information
Brief Title Study Investigating Administration of Prevenar for Post-Marketing Surveillance
Official Title Investigation 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 Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Primary care clinic, secondary and tertiary medical centers
Condition Pneumococcal Infections
Intervention Biological: Prevenar
Prevenar 0.5ml/ Vial and PFS
Study Groups/Cohorts Not 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 Status Completed
Estimated Enrollment
 (submitted: September 13, 2005)
600
Original Enrollment Same as current
Actual Study Completion Date July 2008
Primary Completion Date Not 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
Ages 6 Weeks to 9 Years   (Child)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number NCT00195390
Other Study ID Numbers 0887X-101583
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
Study Sponsor Wyeth is now a wholly owned subsidiary of Pfizer
Collaborators Not Provided
Investigators
Study Director:Medical MonitorWyeth is now a wholly owned subsidiary of Pfizer
PRS Account Wyeth is now a wholly owned subsidiary of Pfizer
Verification Date September 2008