Post-Marketing Study of the Safety of Prevenar (Pneumococcal Conjugate Vaccine, 7-valent)

Completed

• Conditions: Vaccines, Pneumococcal Conjugate Vaccine
• Interventions: Biological: Pneumococcal Conjugate Vaccine, 7-valent (Prevenar)

• Registration Number: NCT00683410
• Lead Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

Brief Summary

To collect post-marketing information on the safety of Prevenar in Filipino patients

Detailed Description

Not available

Study Timeline

• Study Start: 2007-04
• Study First Submitted: 2008-05-21
• Study First Submitted QC: 2008-05-22
• Study First Posted: 2008-05-23
• Primary Completion: 2009-10
• Study Completion: 2009-10
• Status Verified: 2010-10
• Results First Submitted: 2010-10-15
• Results First Submitted QC: 2010-10-15
• Last Update Submitted: 2010-10-15
• Results First Posted: 2010-11-16
• Last Update Posted: 2010-11-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3366

Inclusion Criteria

• All patients from the study center who received or will receive at least one dose of Prevenar according to the approved product indication.

Exclusion Criteria

• Previously discontinued Prevenar therapy due to safety concerns.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
1	Pneumococcal Conjugate Vaccine, 7-valent (Prevenar)	-

Primary Outcome Measures

Name	Time	Method
Number of Participants With Spontaneous Adverse Events	30 days post injection up to 3 years