Safety Surveillance of Pneumococcal 13-valent Conjugate Vaccine Among Filipinos

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01396434
First received: June 22, 2011
Last updated: June 15, 2015
Last verified: June 2015

June 22, 2011
June 15, 2015
December 2011
May 2014   (final data collection date for primary outcome measure)
Number of participants reporting adverse events as a measure of safety [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01396434 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Safety Surveillance of Pneumococcal 13-valent Conjugate Vaccine Among Filipinos
A Non-interventional Study Of The Safety Of Pneumococcal 13-valent Conjugate Vaccine (Prevenar 13) In The Philippines: A Post Marketing Surveillance Study

Prevenar 13 is safe for administration to Filipinos.

Filipino patients prescribed and administered with the vaccine will be monitored for safety Patients prescribed with the vaccine who provides consent for inclusion to the study will be observed.

Observational
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Filipino patients prescribed with the vaccine

Pneumococcal Disease
Biological: Prevenar 13
Prevenar 13 vaccine as prescribed by the physician based on approved product indication
Other Name: Pneumococcal 13-valent Conjugate Vaccine (13vPnC)
Prevenar 13 patients
Intervention: Biological: Prevenar 13
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
3006
May 2014
May 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

Patients prescribed with the vaccine

Exclusion Criteria:

Patients with hypersensitivity to the vaccine

Both
6 Weeks and older
Yes
Contact information is only displayed when the study is recruiting subjects
Philippines
 
NCT01396434
B1851076
No
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
June 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP