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Safety Surveillance of Pneumococcal 13-valent Conjugate Vaccine Among Filipinos

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01396434
First Posted: July 18, 2011
Last Update Posted: January 30, 2017
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.
Information provided by (Responsible Party):
Pfizer
  Purpose
Prevenar 13 is safe for administration to Filipinos.

Condition Intervention Phase
Pneumococcal Disease Biological: Prevenar 13 Phase 4

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • 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.


Enrollment: 3006
Study Start Date: December 2011
Study Completion Date: May 2014
Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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)

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.
  Eligibility

Information from the National Library of Medicine

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

Inclusion Criteria:

Patients prescribed with the vaccine

Exclusion Criteria:

Patients with hypersensitivity to the vaccine

  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT01396434


  Show 121 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01396434     History of Changes
Other Study ID Numbers: B1851076
First Submitted: June 22, 2011
First Posted: July 18, 2011
Results First Submitted: December 5, 2016
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
Vaccines
Heptavalent Pneumococcal Conjugate Vaccine
Immunologic Factors
Physiological Effects of Drugs