NCT00195390

Study Investigating Administration of Prevenar for Post-Marketing Surveillance

Investigation of Prevenar (Pneumococcal 7-Valent Conjugate Vaccine) Administration for Post-Marketing Surveillance

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 600 (estimated)
• Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer · Industry
• Sex: All
• Age: 6 Weeks – 9 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
BIOLOGICAL	Prevenar	Prevenar 0.5ml/ Vial and PFS

Timeline

• Start date: 2004-07-01
• Completion: 2008-07-01
• First posted: 2005-09-19
• Last updated: 2008-09-25

Locations

1 site across 1 country: South Korea