Safety Surveillance of Pneumococcal 13-valent Conjugate Vaccine Among Filipinos
- Conditions
- Pneumococcal Disease
- Interventions
- Biological: Prevenar 13
- Registration Number
- NCT01396434
- Lead Sponsor
- Pfizer
- Brief Summary
Prevenar 13 is safe for administration to Filipinos.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 3006
Patients prescribed with the vaccine
Patients with hypersensitivity to the vaccine
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Prevenar 13 patients Prevenar 13 -
- Primary Outcome Measures
Name Time Method Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) Baseline through and including 28 calendar days after the last administration of study vaccine within the observation period 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (68)
Villanueva Laboratory and Clinics
🇵🇭Bacolod City, Philippines
San Carlos Doctor's Hospital
🇵🇭San Carlos City, Negros Occidental, Philippines
Private Clinic
🇵🇭Zamboanga City, Philippines
Dr. Pablo O. Torre Memorial Medical Center
🇵🇭Bacolod City, Philippines
Las Pinas Doctors Hospital
🇵🇭Las Pinas City, Philippines
PPG, Manila, Philippines
🇵🇭Cebu City, Philippines
Rm4A, Medical Arts Building
🇵🇭Cebu City, Philippines
Rm714B
🇵🇭Manila, Philippines
Emil-Joanna General Hospital
🇵🇭Quezon, Philippines
Centro Medical and Laboratory Clinic
🇵🇭Marikina City, Philippines
Basement
🇵🇭Cebu City, Philippines
Clinica Tapia
🇵🇭Bulacan, Philippines
Riverside Medical Center
🇵🇭Bacolod City, Philippines
Chong Hua Hospital
🇵🇭Cebu, Philippines
Community Health and Development Cooperative Hospital
🇵🇭Davao City, Philippines
Archangel Raphael Pediatric Clinic
🇵🇭Malabon City, Philippines
Malabon Medical Clinic
🇵🇭Malabon City, Philippines
Marikina Valley Medical Center
🇵🇭Marikina City, Philippines
Friendly Care Clinic
🇵🇭Quezon City, Philippines
Medical Arts Building
🇵🇭Bacolod CIty, Philippines
Victorias Commercial Center
🇵🇭Victorias City, Negros Occidental, Philippines
Room 311 Riverside Medical Arts Building
🇵🇭Bacolod City, Philippines
Pediatric Doctor's Clinic
🇵🇭Bulacan, Philippines
St Vincent's Wellness Clinic
🇵🇭Bulacan, Philippines
Centralle Medical Diagnostics and Polyclinic
🇵🇭Caloocan City, Philippines
Care and Cure Hub
🇵🇭Cebu City, Philippines
Cebu Doctors University Hopsital
🇵🇭Cebu City, Philippines
MCA Bauanan Children's Clinic
🇵🇭Batangas, Philippines
417
🇵🇭Bulacan, Philippines
Blk 19 Lot 11
🇵🇭Capiz City, Philippines
Lucena United Doctors Hospital
🇵🇭Lucena City, Philippines
Children's Clinic
🇵🇭Manila, Philippines
Garcia General Hospital
🇵🇭Marikina City, Philippines
Room 605
🇵🇭Marikina City, Philippines
Paranaque Doctors Hospital
🇵🇭Paranaque, Philippines
Metropolitan Medical Center
🇵🇭Manila, Philippines
Room 11
🇵🇭Quezon City, Philippines
Room 505A Chong Hua Medical Arts Building
🇵🇭Cebu City, Philippines
Cebu Doctor University Hospital
🇵🇭Cebu, Philippines
San Pedro Hospital
🇵🇭Davao City, Philippines
1952
🇵🇭Manila, Philippines
Room 706
🇵🇭Manila, Philippines
Chinese General Hospital and Medical Center
🇵🇭Sta. Cruz, Manila, Philippines
Room 220 The Doctor's Hospital, Inc.
🇵🇭Bacolod City, Negros Occidental, Philippines
Medical Plaza
🇵🇭Bacolod City, Philippines
Room 302 Medical Arts Building
🇵🇭Bacolod City, Philippines
Room 413 Medical Arts Building 2
🇵🇭Cebu City, Philippines
Health Science and Wellness Center
🇵🇭Davao City, Philippines
Iligan Specialist Clinic
🇵🇭Iligan City, Philippines
Mabalacat Child Care Clinic
🇵🇭Pampanga, Philippines
Natividad Children's Clinic
🇵🇭Quezon City, Philippines
Room 302-A
🇵🇭Cebu City, Philippines
Room 419 SPC Medical Specialty Center
🇵🇭Cebu City, Philippines
Jesusa Complex
🇵🇭Davao City, Philippines
San Pedro Hospital Inc.
🇵🇭Davao City, Philippines
Room 117 Medical Arts Building
🇵🇭Dumaguete City, Philippines
Tumbicon Polycare
🇵🇭Malabon, Philippines
Chinese General Hospital
🇵🇭Manila, Philippines
Room 210, Metropolitan Medical Center
🇵🇭Manila, Philippines
Maglana Villamor Clinic
🇵🇭Paranaque, Philippines
Madrid Polyclinic
🇵🇭Quezon CIty, Philippines
Philippine Heart Center
🇵🇭Quezon City, Philippines
World Citi Medical Center
🇵🇭Quezon City, Philippines
Maternity and Children's Clinic
🇵🇭Quezon City, Philippines
Community General Hospital
🇵🇭San Pablo City, Philippines
Medical Specialist Clinic
🇵🇭Quezon City, Philippines
Children'S Clinic
🇵🇭Rizal, Philippines
Room 331
🇵🇭Zamboanga City, Philippines