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Study Investigating Administration of Prevenar for Post-Marketing Surveillance

NCT00195390 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 600

Last updated 2008-09-25

No results posted yet for this study

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

Conditions

  • Pneumococcal Infections

Interventions

BIOLOGICAL

Prevenar

Prevenar 0.5ml/ Vial and PFS

Sponsors & Collaborators

  • Wyeth is now a wholly owned subsidiary of Pfizer

    lead INDUSTRY

Principal Investigators

  • Medical Monitor · Wyeth is now a wholly owned subsidiary of Pfizer

Eligibility

Min Age
6 Weeks
Max Age
9 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2004-07-31
Completion
2008-07-31

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00195390 on ClinicalTrials.gov