Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

Safety Surveillance of Pneumococcal 13-valent Conjugate Vaccine Among Filipinos

This study has been completed.
Information provided by (Responsible Party):
Pfizer Identifier:
First received: June 22, 2011
Last updated: June 15, 2015
Last verified: June 2015
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 reporting adverse events as a measure of safety [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

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.

Ages Eligible for Study:   6 Weeks and older   (Child, Adult, Senior)
Genders Eligible for Study:   Both
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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01396434

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

Additional Information:
Responsible Party: Pfizer Identifier: NCT01396434     History of Changes
Other Study ID Numbers: B1851076 
Study First Received: June 22, 2011
Last Updated: June 15, 2015
Health Authority: Philippines : Food and Drug Administration

Additional relevant MeSH terms:
Pneumococcal Infections
Streptococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Heptavalent Pneumococcal Conjugate Vaccine
Immunologic Factors
Physiological Effects of Drugs processed this record on December 09, 2016