Safety Surveillance of Pneumococcal 13-valent Conjugate Vaccine Among Filipinos
A Non-interventional Study Of The Safety Of Pneumococcal 13-valent Conjugate Vaccine (Prevenar 13) In The Philippines: A Post Marketing Surveillance Study
1 other identifier
observational
3,006
1 country
119
Brief Summary
Prevenar 13 is safe for administration to Filipinos.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Dec 2011
Typical duration for all trials
119 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 22, 2011
CompletedFirst Posted
Study publicly available on registry
July 18, 2011
CompletedStudy Start
First participant enrolled
December 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2014
CompletedResults Posted
Study results publicly available
January 30, 2017
CompletedJanuary 30, 2017
January 1, 2016
2.4 years
June 22, 2011
December 5, 2016
December 5, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
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.
Baseline through and including 28 calendar days after the last administration of study vaccine within the observation period
Study Arms (1)
Prevenar 13 patients
Interventions
Prevenar 13 vaccine as prescribed by the physician based on approved product indication
Eligibility Criteria
Filipino patients prescribed with the vaccine
You may qualify if:
- Patients prescribed with the vaccine
You may not qualify if:
- Patients with hypersensitivity to the vaccine
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (119)
Private Clinic
Lipa City, Batangas, Philippines
Private Clinic
Tagbilaran City, Bohol, Philippines
Private Clinic
Malolos, Bulacan, Philippines
Cebu Doctor University Hospital
Cebu, Cebu, 6000, Philippines
Room 220 The Doctor's Hospital, Inc.
Bacolod City, Negros Occidental, Philippines
Private Clinic
San Carlos City, Negros Occidental, Philippines
San Carlos Doctor's Hospital
San Carlos City, Negros Occidental, Philippines
Victorias Commercial Center
Victorias City, Negros Occidental, Philippines
Private Clinic
Dagupan, Pangasinan, Philippines
Private Clinic
Mangaldan, Pangasinan, Philippines
Private Clinic
Pozorrubio, Pangasinan, Philippines
Private Clinic
Angeles City, Philippines
Private Clinic
Antipolo City, Philippines
Dr. Pablo O. Torre Memorial Medical Center
Bacolod City, 6100, Philippines
Medical Arts Building
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
Room 311 Riverside Medical Arts Building
Bacolod City, Philippines
Villanueva Laboratory and Clinics
Bacolod City, Philippines
MCA Bauanan Children's Clinic
Batangas, Philippines
Private Clinic
Batangas, Philippines
Metropolitan Medical Center
Binondo, Manila, Philippines
Private Clinic
Bocaue, Philippines
417
Bulacan, Philippines
Clinica Tapia
Bulacan, Philippines
Pediatric Doctor's Clinic
Bulacan, Philippines
Private Clinic
Bulacan, Philippines
St Vincent's Wellness Clinic
Bulacan, Philippines
Room 11
Cagayan de Oro, Philippines
Centralle Medical Diagnostics and Polyclinic
Caloocan, Philippines
Private Clinic
Caloocan, Philippines
Private Clinic
Candelaria, Philippines
Blk 19 Lot 11
Capiz, Philippines
Private Clinic
Cavite, Philippines
Chong Hua Hospital
Cebu, 6000, Philippines
Chong Hua Hospital
Cebu, Philippines
Basement
Cebu City, Philippines
Care and Cure Hub
Cebu City, Philippines
Cebu Doctors University Hopsital
Cebu City, Philippines
Chong Hua Hospital
Cebu City, Philippines
PPG, Manila, Philippines
Cebu City, Philippines
Private Clinic
Cebu City, Philippines
Rm4A, Medical Arts Building
Cebu City, Philippines
Room 302-A
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
Private Clinic
Dagupan, Philippines
Community Health and Development Cooperative Hospital
Davao City, Philippines
Health Science and Wellness Center
Davao City, Philippines
Jesusa Complex
Davao City, Philippines
Private Clinic
Davao City, Philippines
San Pedro Hospital Inc.
Davao City, Philippines
San Pedro Hospital
Davao City, Philippines
Private Clinic
Dipolog City, Philippines
Private Clinic
Dumaguete, Philippines
Room 117 Medical Arts Building
Dumaguete, Philippines
Iligan Specialist Clinic
Iligan City, Philippines
Private Clinic
Iloilo City, Philippines
Private Clinic
Koronadal, Philippines
Private Clinic
Laguna, Philippines
Las Pinas Doctors Hospital
Las Piñas, Philippines
Private Clinic
Legaspi, Philippines
Private Clinic
Lipa City, Philippines
Lucena United Doctors Hospital
Lucena City, Philippines
Private Clinic
Lucena City, Philippines
Private Clinic
Makati City, Philippines
Archangel Raphael Pediatric Clinic
Malabon, Philippines
Children's Clinic
Malabon, Philippines
Malabon Medical Clinic
Malabon, Philippines
Tumbicon Polycare
Malabon, Philippines
Private Clinic
Malolos, Philippines
Private Clinic
Mandaluyong, Philippines
Metropolitan Medical Center
Manila, 1000, Philippines
1952
Manila, Philippines
Children's Clinic
Manila, Philippines
Chinese General Hospital
Manila, Philippines
Private Clinic
Manila, Philippines
Rm714B
Manila, Philippines
Room 210, Metropolitan Medical Center
Manila, Philippines
Room 706
Manila, Philippines
Marikina Valley Medical Center
Marikina City, 1801, Philippines
Centro Medical and Laboratory Clinic
Marikina City, Philippines
Garcia General Hospital
Marikina City, Philippines
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 City, Philippines
Paranaque Doctors Hospital
Paranaque City, Philippines
Private Clinic
Pasig, Philippines
Emil-Joanna General Hospital
Quezon, Philippines
Private Clinic
Quezon, Philippines
Philippine Heart Center
Quezon City, 1100, Philippines
Friendly Care Clinic
Quezon City, Philippines
Madrid Polyclinic
Quezon City, Philippines
Maternity and Children's Clinic
Quezon City, Philippines
Medical Specialist Clinic
Quezon City, Philippines
Natividad Children's Clinic
Quezon City, Philippines
Philippine Heart Center
Quezon City, Philippines
Private Clinic
Quezon City, Philippines
Room 11
Quezon City, Philippines
World Citi Medical Center
Quezon City, Philippines
Children'S Clinic
Rizal, Philippines
Private Clinic
Rizal, Philippines
Community General Hospital
San Pablo, Philippines
Private Clinic
San Pablo, Philippines
Chinese General Hospital and Medical Center
Santa Cruz, Manila, Philippines
Private Clinic
South Luzon, Philippines
Private Clinic
Tagbilaran City, Philippines
Private Clinic
Tarlac City, Philippines
Private Clinic
Urdaneta, Philippines
Private Clinic
Valenzuela, Philippines
Private Clinic
Zamboanga City, Philippines
Room 331
Zamboanga City, Philippines
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Limitations and Caveats
The use of 13vPnC was based on the investigator's clinical judgment and was assumed to be consistent with the product's approved label.
Results Point of Contact
- Title
- Pfizer ClinicalTrials.gov Call Center
- Organization
- Pfizer, Inc.
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- observational
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 22, 2011
First Posted
July 18, 2011
Study Start
December 1, 2011
Primary Completion
May 1, 2014
Study Completion
May 1, 2014
Last Updated
January 30, 2017
Results First Posted
January 30, 2017
Record last verified: 2016-01