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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2011

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 22, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 15, 2011

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 18, 2011

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 30, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 5, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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