Safety Surveillance of Pneumococcal 13-valent Conjugate Vaccine Among Filipinos

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Pfizer
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01396434
First received: June 22, 2011
Last updated: July 25, 2014
Last verified: July 2014
  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 reporting adverse events as a measure of safety [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 3000
Study Start Date: December 2011
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 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

Ages Eligible for Study:   6 Weeks to 5 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
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 ClinicalTrials.gov identifier: NCT01396434

Contacts
Contact: Pfizer CT.gov Call Center 1-800-718-1021

  Show 106 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01396434     History of Changes
Other Study ID Numbers: B1851076
Study First Received: June 22, 2011
Last Updated: July 25, 2014
Health Authority: Philippines : Food and Drug Administration

ClinicalTrials.gov processed this record on July 29, 2014