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

  Hide Study Locations
Locations
Philippines
Private Clinic Recruiting
Lipa City, Batangas, Philippines
Private Clinic Recruiting
Tagbilaran City, Bohol, Philippines
Private Clinic Recruiting
Malolos, Bulacan, Philippines
Room 220 The Doctor's Hospital, Inc. Recruiting
Bacolod City, Negros Occidental, Philippines
Private Clinic Recruiting
San Carlos City, Negros Occidental, Philippines
San Carlos Doctor's Hospital Recruiting
San Carlos City, Negros Occidental, Philippines
Private Clinic Recruiting
Dagupan City, Pangasinan, Philippines
Private Clinic Recruiting
Mangaldan, Pangasinan, Philippines
Private Clinic Recruiting
Pozorrubio, Pangasinan, Philippines
Private Clinic Not yet recruiting
Tarlac City, Tarlac, Philippines
Private Clinic Recruiting
Angeles City, Philippines
Private Clinic Recruiting
Antipolo City, Philippines
Medical Arts Building Recruiting
Bacolod CIty, Philippines
Dr. Pablo O. Torre Memorial Medical Center Recruiting
Bacolod City, Philippines, 6100
Room 311 Riverside Medical Arts Building Recruiting
Bacolod City, Philippines
Room 302 Medical Arts Building Recruiting
Bacolod City, Philippines
Private Clinic Recruiting
Bacolod City, Philippines
MCA Bauanan Children's Clinic Recruiting
Batangas, Philippines
Private Clinic Recruiting
Batangas, Philippines
Private Clinic Recruiting
Batangas City, Philippines
Metropolitan Medical Center Recruiting
Binondo, Manila, Philippines
Private Clinic Recruiting
Bocaue, Philippines
Pediatric Doctor's Clinic Recruiting
Bulacan, Philippines
417 Recruiting
Bulacan, Philippines
Clinica Tapia Recruiting
Bulacan, Philippines
St Vincent's Wellness Clinic Recruiting
Bulacan, Philippines
Private Clinic Recruiting
Bulacan, Philippines
Room 11 Recruiting
Cagayan De Oro City, Philippines
Centralle Medical Diagnostics and Polyclinic Recruiting
Caloocan City, Philippines
Private Clinic Recruiting
Caloocan City, Philippines
Private Clinic Recruiting
Candelaria City, Philippines
Blk 19 Lot 11 Recruiting
Capiz City, Philippines
Private Clinic Recruiting
Cavite, Philippines
Room 419 SPC Medical Specialty Center Recruiting
Cebu City, Philippines
Room 302-A Recruiting
Cebu City, Philippines
Room 505A Chong Hua Medical Arts Building Recruiting
Cebu City, Philippines
Basement Recruiting
Cebu City, Philippines
Care and Cure Hub Recruiting
Cebu City, Philippines
Rm4A, Medical Arts Building Recruiting
Cebu City, Philippines
Private Clinic Recruiting
Cebu City, Philippines
PPG, Manila, Philippines Recruiting
Cebu City, Philippines
Room 413 Medical Arts Building 2 Recruiting
Cebu City, Philippines
Private Clinic Recruiting
Dagupan City, Philippines
Private Clinic Recruiting
Davao City, Philippines
Private Clinic Recruiting
Dipolog City, Philippines
Private Clinic Recruiting
Dumaguete City, Philippines
Room 117 Medical Arts Building Recruiting
Dumaguete City, Philippines
Iligan Specialist Clinic Recruiting
Iligan City, Philippines
Private Clinic Recruiting
Iloilo City, Philippines
Private Clinic Recruiting
Koronadal City, Philippines
Private Clinic Recruiting
Laguna, Philippines
Private Clinic Recruiting
Legaspi City, Philippines
Private Clinic Recruiting
Lipa City, Philippines
Private Clinic Recruiting
Lucena City, Philippines
Lucena United Doctors Hospital Recruiting
Lucena City, Philippines
Private Clinic Recruiting
Makati City, Philippines
Tumbicon Polycare Recruiting
Malabon, Philippines
Children's Clinic Recruiting
Malabon City, Philippines
Malabon Medical Clinic Recruiting
Malabon City, Philippines
Archangel Raphael Pediatric Clinic Recruiting
Malabon City, Philippines
Private Clinic Recruiting
Malolos City, Philippines
Private Clinic Recruiting
Mandaluyong City, Philippines
1952 Recruiting
Manila, Philippines
Room 706 Recruiting
Manila, Philippines
Private Clinic Active, not recruiting
Manila, Philippines
Room 210, Metropolitan Medical Center Recruiting
Manila, Philippines
Chinese General Hospital Recruiting
Manila, Philippines
Rm714B Recruiting
Manila, Philippines
Metropolitan Medical Center Recruiting
Manila, Philippines, 1000
Children's Clinic Recruiting
Manila, Philippines
Private Clinic Recruiting
Manila, Philippines
Garcia General Hospital Recruiting
Marikina City, Philippines
Marikina Valley Medical Center Recruiting
Marikina City, Philippines, 1801
Private Clinic Recruiting
Marikina City, Philippines
Centro Medical and Laboratory Clinic Recruiting
Marikina City, Philippines
Room 605 Recruiting
Marikina City, Philippines
Private Clinic Recruiting
Negors Occidental, Philippines
Private Clinic Recruiting
Negros Occidental, Philippines
Mabalacat Child Care Clinic Recruiting
Pampanga, Philippines
Private Clinic Recruiting
Pangasinan, Philippines
Private Clinic Recruiting
Pasig, Philippines
Private Clinic Recruiting
Pasig City, Philippines
Private Clinic Recruiting
Quezon, Philippines
Emil-Joanna General Hospital Recruiting
Quezon, Philippines
Philippine Heart Center Recruiting
Quezon City, Philippines
Natividad Children's Clinic Recruiting
Quezon City, Philippines
Madrid Polyclinic Recruiting
Quezon CIty, Philippines
Private Clinic Recruiting
Quezon City, Philippines
Philippine Heart Center Recruiting
Quezon City, Philippines, 1100
Room 11 Recruiting
Quezon City, Philippines
Medical Specialist Clinic Recruiting
Quezon City, Philippines
Friendly Care Clinic Recruiting
Quezon City, Philippines
Maternity and Children's Clinic Recruiting
Quezon City, Philippines
World Citi Medical Center Recruiting
Quezon City, Philippines
Children'S Clinic Recruiting
Rizal, Philippines
Private Clinic Recruiting
Rizal, Philippines
Private Clinic Recruiting
San Pablo City, Philippines
Community General Hospital Recruiting
San Pablo City, Philippines
Private Clinic Recruiting
South Luzon, Philippines
Chinese General Hospital and Medical Center Recruiting
Sta. Cruz, Manila, Philippines
Private Clinic Recruiting
Tagbilaran City, Philippines
Private Clinic Recruiting
Tarlac City, Philippines
Private Clinic Recruiting
Urdaneta City, Philippines
Private Clinic Recruiting
Valenzuela City, Philippines
Room 331 Recruiting
Zamboanga City, Philippines
Private Clinic Recruiting
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: July 25, 2014
Health Authority: Philippines : Food and Drug Administration

ClinicalTrials.gov processed this record on August 01, 2014