Safety Surveillance of Pneumococcal 13-valent Conjugate Vaccine Among Filipinos

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01396434
Recruitment Status : Completed
First Posted : July 18, 2011
Results First Posted : January 30, 2017
Last Update Posted : January 30, 2017
Information provided by (Responsible Party):

June 22, 2011
July 18, 2011
December 5, 2016
January 30, 2017
January 30, 2017
December 2011
May 2014   (Final data collection date for primary outcome measure)
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Baseline through and including 28 calendar days after the last administration of study vaccine within the observation period ]
All observed or volunteered AEs and SAEs regardless of treatment group or suspected causal relationship to 13vPnC were reported. An AE was any untoward medical occurrence in a participant who received 13vPnC. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both SAEs and non-SAEs.
Number of participants reporting adverse events as a measure of safety [ Time Frame: 2 years ]
Complete list of historical versions of study NCT01396434 on Archive Site
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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.
Time Perspective: Prospective
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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
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
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

Sexes Eligible for Study: All
6 Weeks and older   (Child, Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
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Study Director: Pfizer Call Center Pfizer
January 2016