Safety Surveillance of Pneumococcal 13-valent Conjugate Vaccine Among Filipinos

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2013 by Pfizer
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01396434
First received: June 22, 2011
Last updated: September 10, 2014
Last verified: October 2013

June 22, 2011
September 10, 2014
December 2011
September 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.
 
Recruiting
3000
September 2014
September 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 to 5 Years
No
Contact: Pfizer CT.gov Call Center 1-800-718-1021
Philippines
 
NCT01396434
B1851076
No
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
October 2013

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