Safety Surveillance of Pneumococcal 13-valent Conjugate Vaccine Among Filipinos

December 5, 2016 updated by: Pfizer

A Non-interventional Study Of The Safety Of Pneumococcal 13-valent Conjugate Vaccine (Prevenar 13) In The Philippines: A Post Marketing Surveillance Study

Prevenar 13 is safe for administration to Filipinos.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

3006

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 month and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Filipino patients prescribed with the vaccine

Description

Inclusion Criteria:

Patients prescribed with the vaccine

Exclusion Criteria:

Patients with hypersensitivity to the vaccine

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Prevenar 13 patients
Biological: Prevenar 13
Prevenar 13 vaccine as prescribed by the physician based on approved product indication
Other Names:
  • Pneumococcal 13-valent Conjugate Vaccine (13vPnC)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time Frame: 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.
Baseline through and including 28 calendar days after the last administration of study vaccine within the observation period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2011

Primary Completion (Actual)

May 1, 2014

Study Completion (Actual)

May 1, 2014

Study Registration Dates

First Submitted

June 22, 2011

First Submitted That Met QC Criteria

July 15, 2011

First Posted (Estimate)

July 18, 2011

Study Record Updates

Last Update Posted (Estimate)

January 30, 2017

Last Update Submitted That Met QC Criteria

December 5, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B1851076

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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