Study Investigating Administration of Prevenar for Post-Marketing Surveillance
NCT00195390
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Descriptive Information | ||||
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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.
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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 | 600 | |||
Original Enrollment | Same as current | |||
Actual Study Completion Date | July 2008 | |||
Primary Completion Date | Not Provided | |||
Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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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 |
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PRS Account | Wyeth is now a wholly owned subsidiary of Pfizer | |||
Verification Date | September 2008 |