Post-Marketing Study of the Safety of Prevenar (Pneumococcal Conjugate Vaccine, 7-valent)
A Prospective, Observational Study to Monitor Safety in Patients Who Were Administered With Pneumococcal Conjugate Vaccine, 7-valent (Prevenar) 0.5 mL by Intramuscular Injection
1 other identifier
observational
3,366
1 country
1
Brief Summary
To collect post-marketing information on the safety of Prevenar in Filipino patients
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2007
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2007
CompletedFirst Submitted
Initial submission to the registry
May 21, 2008
CompletedFirst Posted
Study publicly available on registry
May 23, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2009
CompletedResults Posted
Study results publicly available
November 16, 2010
CompletedNovember 16, 2010
October 1, 2010
2.5 years
May 21, 2008
October 15, 2010
October 15, 2010
Conditions
Outcome Measures
Primary Outcomes (1)
Number of Participants With Spontaneous Adverse Events
30 days post injection up to 3 years
Study Arms (1)
1
Interventions
Eligibility Criteria
Primary Care
You may qualify if:
- All patients from the study center who received or will receive at least one dose of Prevenar according to the approved product indication.
You may not qualify if:
- Previously discontinued Prevenar therapy due to safety concerns.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Unknown Facility
City of Muntinlupa, Philippines
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Pfizer ClinicalTrials.gov Call Center
- Organization
- Pfizer, Inc.
Study Officials
- STUDY DIRECTOR
Medical Monitor
Wyeth is now a wholly owned subsidiary of Pfizer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
May 21, 2008
First Posted
May 23, 2008
Study Start
April 1, 2007
Primary Completion
October 1, 2009
Study Completion
October 1, 2009
Last Updated
November 16, 2010
Results First Posted
November 16, 2010
Record last verified: 2010-10