Clinical trial NCT01396434: Safety Surveillance of Pneumococcal 13-valent Conjugate Vaccine Among Filipinos
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pneumococcal Disease
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2011-07-18
Enrollment: 3006
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Filipino patients prescribed with the vaccine

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.

Eligibility criteria: Inclusion Criteria:

Patients prescribed with the vaccine

Exclusion Criteria:

Patients with hypersensitivity to the vaccine

Primary outcomes:
measure: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: Baseline through and including 28 calendar days after the last administration of study vaccine within the observation period
Secondary outcomes:
Other outcomes:
Locations:
city: Lipa City
country: Philippines
facility: Private Clinic
state: Batangas
city: Tagbilaran City
country: Philippines
facility: Private Clinic
state: Bohol
city: Malolos
country: Philippines
facility: Private Clinic
state: Bulacan
city: Bacolod City
country: Philippines
facility: Room 220 The Doctor's Hospital, Inc.
state: Negros Occidental
city: San Carlos City
country: Philippines
facility: Private Clinic
state: Negros Occidental
city: San Carlos City
country: Philippines
facility: San Carlos Doctor's Hospital
state: Negros Occidental
city: Victorias City
country: Philippines
facility: Victorias Commercial Center
state: Negros Occidental
city: Dagupan City
country: Philippines
facility: Private Clinic
state: Pangasinan
city: Mangaldan
country: Philippines
facility: Private Clinic
state: Pangasinan
city: Pozorrubio
country: Philippines
facility: Private Clinic
state: Pangasinan
city: Angeles City
country: Philippines
facility: Private Clinic
city: Antipolo City
country: Philippines
facility: Private Clinic
city: Bacolod City
country: Philippines
facility: Dr. Pablo O. Torre Memorial Medical Center
city: Bacolod CIty
country: Philippines
facility: Medical Arts Building
city: Bacolod City
country: Philippines
facility: Medical Plaza
city: Bacolod City
country: Philippines
facility: Private Clinic
city: Bacolod City
country: Philippines
facility: Riverside Medical Center
city: Bacolod City
country: Philippines
facility: Room 302 Medical Arts Building
city: Bacolod City
country: Philippines
facility: Room 311 Riverside Medical Arts Building
city: Bacolod City
country: Philippines
facility: Villanueva Laboratory and Clinics
city: Batangas City
country: Philippines
facility: Private Clinic
city: Batangas
country: Philippines
facility: MCA Bauanan Children's Clinic
city: Batangas
country: Philippines
facility: Private Clinic
city: Binondo, Manila
country: Philippines
facility: Metropolitan Medical Center
city: Bocaue
country: Philippines
facility: Private Clinic
city: Bulacan
country: Philippines
facility: 417
city: Bulacan
country: Philippines
facility: Clinica Tapia
city: Bulacan
country: Philippines
facility: Pediatric Doctor's Clinic
city: Bulacan
country: Philippines
facility: Private Clinic
city: Bulacan
country: Philippines
facility: St Vincent's Wellness Clinic
city: Cagayan De Oro City
country: Philippines
facility: Room 11
city: Caloocan City
country: Philippines
facility: Centralle Medical Diagnostics and Polyclinic
city: Caloocan City
country: Philippines
facility: Private Clinic
city: Candelaria City
country: Philippines
facility: Private Clinic
city: Capiz City
country: Philippines
facility: Blk 19 Lot 11
city: Cavite
country: Philippines
facility: Private Clinic
city: Cebu City
country: Philippines
facility: Basement
city: Cebu City
country: Philippines
facility: Care and Cure Hub
city: Cebu City
country: Philippines
facility: Cebu Doctors University Hopsital
city: Cebu City
country: Philippines
facility: Chong Hua Hospital
city: Cebu City
country: Philippines
facility: PPG, Manila, Philippines
city: Cebu City
country: Philippines
facility: Private Clinic
city: Cebu City
country: Philippines
facility: Rm4A, Medical Arts Building
city: Cebu City
country: Philippines
facility: Room 302-A
city: Cebu City
country: Philippines
facility: Room 413 Medical Arts Building 2
city: Cebu City
country: Philippines
facility: Room 419 SPC Medical Specialty Center
city: Cebu City
country: Philippines
facility: Room 505A Chong Hua Medical Arts Building
city: Cebu
country: Philippines
facility: Cebu Doctor University Hospital
city: Cebu
country: Philippines
facility: Chong Hua Hospital
city: Cebu
country: Philippines
facility: Chong Hua Hospital
city: Dagupan City
country: Philippines
facility: Private Clinic
city: Davao City
country: Philippines
facility: Community Health and Development Cooperative Hospital
city: Davao City
country: Philippines
facility: Health Science and Wellness Center
city: Davao City
country: Philippines
facility: Jesusa Complex
city: Davao City
country: Philippines
facility: Private Clinic
city: Davao City
country: Philippines
facility: San Pedro Hospital Inc.
city: Davao City
country: Philippines
facility: San Pedro Hospital
city: Dipolog City
country: Philippines
facility: Private Clinic
city: Dumaguete City
country: Philippines
facility: Private Clinic
city: Dumaguete City
country: Philippines
facility: Room 117 Medical Arts Building
city: Iligan City
country: Philippines
facility: Iligan Specialist Clinic
city: Iloilo City
country: Philippines
facility: Private Clinic
city: Koronadal City
country: Philippines
facility: Private Clinic
city: Laguna
country: Philippines
facility: Private Clinic
city: Las Pinas City
country: Philippines
facility: Las Pinas Doctors Hospital
city: Legaspi City
country: Philippines
facility: Private Clinic
city: Lipa City
country: Philippines
facility: Private Clinic
city: Lucena City
country: Philippines
facility: Lucena United Doctors Hospital
city: Lucena City
country: Philippines
facility: Private Clinic
city: Makati City
country: Philippines
facility: Private Clinic
city: Malabon City
country: Philippines
facility: Archangel Raphael Pediatric Clinic
city: Malabon City
country: Philippines
facility: Children's Clinic
city: Malabon City
country: Philippines
facility: Malabon Medical Clinic
city: Malabon
country: Philippines
facility: Tumbicon Polycare
city: Malolos City
country: Philippines
facility: Private Clinic
city: Mandaluyong City
country: Philippines
facility: Private Clinic
city: Manila
country: Philippines
facility: Metropolitan Medical Center
city: Manila
country: Philippines
facility: 1952
city: Manila
country: Philippines
facility: Children's Clinic
city: Manila
country: Philippines
facility: Chinese General Hospital
city: Manila
country: Philippines
facility: Private Clinic
city: Manila
country: Philippines
facility: Rm714B
city: Manila
country: Philippines
facility: Room 210, Metropolitan Medical Center
city: Manila
country: Philippines
facility: Room 706
city: Marikina City
country: Philippines
facility: Marikina Valley Medical Center
city: Marikina City
country: Philippines
facility: Centro Medical and Laboratory Clinic
city: Marikina City
country: Philippines
facility: Garcia General Hospital
city: Marikina City
country: Philippines
facility: Private Clinic
city: Marikina City
country: Philippines
facility: Room 605
city: Negors Occidental
country: Philippines
facility: Private Clinic
city: Negros Occidental
country: Philippines
facility: Private Clinic
city: Pampanga
country: Philippines
facility: Mabalacat Child Care Clinic
city: Pangasinan
country: Philippines
facility: Private Clinic
city: Paranaque
country: Philippines
facility: Maglana Villamor Clinic
city: Paranaque
country: Philippines
facility: Paranaque Doctors Hospital
city: Pasig City
country: Philippines
facility: Private Clinic
city: Pasig
country: Philippines
facility: Private Clinic
city: Quezon City
country: Philippines
facility: Philippine Heart Center
city: Quezon City
country: Philippines
facility: Friendly Care Clinic
city: Quezon CIty
country: Philippines
facility: Madrid Polyclinic
city: Quezon City
country: Philippines
facility: Maternity and Children's Clinic
city: Quezon City
country: Philippines
facility: Medical Specialist Clinic
city: Quezon City
country: Philippines
facility: Natividad Children's Clinic
city: Quezon City
country: Philippines
facility: Philippine Heart Center
city: Quezon City
country: Philippines
facility: Private Clinic
city: Quezon City
country: Philippines
facility: Room 11
city: Quezon City
country: Philippines
facility: World Citi Medical Center
city: Quezon
country: Philippines
facility: Emil-Joanna General Hospital
city: Quezon
country: Philippines
facility: Private Clinic
city: Rizal
country: Philippines
facility: Children'S Clinic
city: Rizal
country: Philippines
facility: Private Clinic
city: San Pablo City
country: Philippines
facility: Community General Hospital
city: San Pablo City
country: Philippines
facility: Private Clinic
city: South Luzon
country: Philippines
facility: Private Clinic
city: Sta. Cruz, Manila
country: Philippines
facility: Chinese General Hospital and Medical Center
city: Tagbilaran City
country: Philippines
facility: Private Clinic
city: Tarlac City
country: Philippines
facility: Private Clinic
city: Urdaneta City
country: Philippines
facility: Private Clinic
city: Valenzuela City
country: Philippines
facility: Private Clinic
city: Zamboanga City
country: Philippines
facility: Private Clinic
city: Zamboanga City
country: Philippines
facility: Room 331
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: