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):

Brief Summary:
Prevenar 13 is safe for administration to Filipinos.

Condition or disease Intervention/treatment
Pneumococcal Disease Biological: Prevenar 13

Detailed Description:
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.

Study Type : Observational
Actual Enrollment : 3006 participants
Time Perspective: Prospective
Official Title: A Non-interventional Study Of The Safety Of Pneumococcal 13-valent Conjugate Vaccine (Prevenar 13) In The Philippines: A Post Marketing Surveillance Study
Study Start Date : December 2011
Actual Primary Completion Date : May 2014
Actual Study Completion Date : May 2014

Group/Cohort Intervention/treatment
Prevenar 13 patients Biological: Prevenar 13
Prevenar 13 vaccine as prescribed by the physician based on approved product indication
Other Name: Pneumococcal 13-valent Conjugate Vaccine (13vPnC)

Primary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Weeks and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Filipino patients prescribed with the vaccine

Inclusion Criteria:

Patients prescribed with the vaccine

Exclusion Criteria:

Patients with hypersensitivity to the vaccine

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01396434

  Show 121 Study Locations
Sponsors and Collaborators
Study Director: Pfizer Call Center Pfizer

Additional Information:
Responsible Party: Pfizer Identifier: NCT01396434     History of Changes
Other Study ID Numbers: B1851076
First Posted: July 18, 2011    Key Record Dates
Results First Posted: January 30, 2017
Last Update Posted: January 30, 2017
Last Verified: January 2016

Additional relevant MeSH terms:
Pneumococcal Infections
Streptococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Heptavalent Pneumococcal Conjugate Vaccine
Immunologic Factors
Physiological Effects of Drugs