Safety Surveillance of Pneumococcal 13-valent Conjugate Vaccine Among Filipinos

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01396434
First received: June 22, 2011
Last updated: March 13, 2015
Last verified: March 2015
  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 ]

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

Ages Eligible for Study:   6 Weeks and older
Genders Eligible for Study:   Both
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
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

  Hide Study Locations
Locations
Philippines
Private Clinic
Lipa City, Batangas, Philippines
Private Clinic
Tagbilaran City, Bohol, Philippines
Private Clinic
Malolos, Bulacan, Philippines
Room 220 The Doctor's Hospital, Inc.
Bacolod City, Negros Occidental, Philippines
San Carlos Doctor's Hospital
San Carlos City, Negros Occidental, Philippines
Private Clinic
San Carlos City, Negros Occidental, Philippines
Victorias Commercial Center
Victorias City, Negros Occidental, Philippines
Private Clinic
Dagupan City, Pangasinan, Philippines
Private Clinic
Mangaldan, Pangasinan, Philippines
Private Clinic
Pozorrubio, Pangasinan, Philippines
Private Clinic
Angeles City, Philippines
Private Clinic
Antipolo City, Philippines
Medical Arts Building
Bacolod CIty, Philippines
Villanueva Laboratory and Clinics
Bacolod City, Philippines
Medical Plaza
Bacolod City, Philippines
Private Clinic
Bacolod City, Philippines
Riverside Medical Center
Bacolod City, Philippines
Room 302 Medical Arts Building
Bacolod City, Philippines
Dr. Pablo O. Torre Memorial Medical Center
Bacolod City, Philippines, 6100
Room 311 Riverside Medical Arts Building
Bacolod City, Philippines
MCA Bauanan Children's Clinic
Batangas, Philippines
Private Clinic
Batangas, Philippines
Private Clinic
Batangas City, Philippines
Metropolitan Medical Center
Binondo, Manila, Philippines
Private Clinic
Bocaue, Philippines
St Vincent's Wellness Clinic
Bulacan, Philippines
417
Bulacan, Philippines
Pediatric Doctor's Clinic
Bulacan, Philippines
Private Clinic
Bulacan, Philippines
Clinica Tapia
Bulacan, Philippines
Room 11
Cagayan De Oro City, Philippines
Centralle Medical Diagnostics and Polyclinic
Caloocan City, Philippines
Private Clinic
Caloocan City, Philippines
Private Clinic
Candelaria City, Philippines
Blk 19 Lot 11
Capiz City, Philippines
Private Clinic
Cavite, Philippines
Chong Hua Hospital
Cebu, Philippines
Chong Hua Hospital
Cebu, Philippines, 6000
Cebu Doctor University Hospital
Cebu, Philippines, 6000
Room 302-A
Cebu City, Philippines
PPG, Manila, Philippines
Cebu City, Philippines
Private Clinic
Cebu City, Philippines
Rm4A, Medical Arts Building
Cebu City, Philippines
Chong Hua Hospital
Cebu City, Philippines
Room 413 Medical Arts Building 2
Cebu City, Philippines
Room 419 SPC Medical Specialty Center
Cebu City, Philippines
Room 505A Chong Hua Medical Arts Building
Cebu City, Philippines
Cebu Doctors University Hopsital
Cebu City, Philippines
Care and Cure Hub
Cebu City, Philippines
Basement
Cebu City, Philippines
Private Clinic
Dagupan City, Philippines
Jesusa Complex
Davao City, Philippines
Health Science and Wellness Center
Davao City, Philippines
Private Clinic
Davao City, Philippines
San Pedro Hospital
Davao City, Philippines
San Pedro Hospital Inc.
Davao City, Philippines
Community Health and Development Cooperative Hospital
Davao City, Philippines
Private Clinic
Dipolog City, Philippines
Private Clinic
Dumaguete City, Philippines
Room 117 Medical Arts Building
Dumaguete City, Philippines
Iligan Specialist Clinic
Iligan City, Philippines
Private Clinic
Iloilo City, Philippines
Private Clinic
Koronadal City, Philippines
Private Clinic
Laguna, Philippines
Las Pinas Doctors Hospital
Las Pinas City, Philippines
Private Clinic
Legaspi City, Philippines
Private Clinic
Lipa City, Philippines
Lucena United Doctors Hospital
Lucena City, Philippines
Private Clinic
Lucena City, Philippines
Private Clinic
Makati City, Philippines
Tumbicon Polycare
Malabon, Philippines
Children's Clinic
Malabon City, Philippines
Malabon Medical Clinic
Malabon City, Philippines
Archangel Raphael Pediatric Clinic
Malabon City, Philippines
Private Clinic
Malolos City, Philippines
Private Clinic
Mandaluyong City, Philippines
Children's Clinic
Manila, Philippines
Room 706
Manila, Philippines
Chinese General Hospital
Manila, Philippines
Metropolitan Medical Center
Manila, Philippines, 1000
Private Clinic
Manila, Philippines
Rm714B
Manila, Philippines
Room 210, Metropolitan Medical Center
Manila, Philippines
1952
Manila, Philippines
Centro Medical and Laboratory Clinic
Marikina City, Philippines
Garcia General Hospital
Marikina City, Philippines
Marikina Valley Medical Center
Marikina City, Philippines, 1801
Private Clinic
Marikina City, Philippines
Room 605
Marikina City, Philippines
Private Clinic
Negors Occidental, Philippines
Private Clinic
Negros Occidental, Philippines
Mabalacat Child Care Clinic
Pampanga, Philippines
Private Clinic
Pangasinan, Philippines
Maglana Villamor Clinic
Paranaque, Philippines
Paranaque Doctors Hospital
Paranaque, Philippines
Private Clinic
Pasig, Philippines
Private Clinic
Pasig City, Philippines
Emil-Joanna General Hospital
Quezon, Philippines
Private Clinic
Quezon, Philippines
Madrid Polyclinic
Quezon CIty, Philippines
Maternity and Children's Clinic
Quezon City, Philippines
Natividad Children's Clinic
Quezon City, Philippines
Philippine Heart Center
Quezon City, Philippines, 1100
Philippine Heart Center
Quezon City, Philippines
Private Clinic
Quezon City, Philippines
Room 11
Quezon City, Philippines
World Citi Medical Center
Quezon City, Philippines
Friendly Care Clinic
Quezon City, Philippines
Medical Specialist Clinic
Quezon City, Philippines
Children'S Clinic
Rizal, Philippines
Private Clinic
Rizal, Philippines
Community General Hospital
San Pablo City, Philippines
Private Clinic
San Pablo City, Philippines
Private Clinic
South Luzon, Philippines
Chinese General Hospital and Medical Center
Sta. Cruz, Manila, Philippines
Private Clinic
Tagbilaran City, Philippines
Private Clinic
Tarlac City, Philippines
Private Clinic
Urdaneta City, Philippines
Private Clinic
Valenzuela City, Philippines
Private Clinic
Zamboanga City, Philippines
Room 331
Zamboanga City, Philippines
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: March 13, 2015
Health Authority: Philippines : Food and Drug Administration

ClinicalTrials.gov processed this record on May 21, 2015