Safety Surveillance of Pneumococcal 13-valent Conjugate Vaccine Among Filipinos

NCT01396434

Last updated date
Study Location
Private Clinic
Lipa City, Batangas, , Philippines
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Pneumococcal Disease
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
6 + weeks
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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Patients prescribed with the vaccine

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


Patients with hypersensitivity to the vaccine

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Advanced Information
Descriptive Information
Brief Title 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
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.
Study Type Observational
Study Design Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Filipino patients prescribed with the vaccine
Condition Pneumococcal Disease
Intervention Biological: Prevenar 13
Prevenar 13 vaccine as prescribed by the physician based on approved product indication
Other Name: Pneumococcal 13-valent Conjugate Vaccine (13vPnC)
Study Groups/Cohorts Prevenar 13 patients
Intervention: Biological: Prevenar 13
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: March 13, 2015)
3006
Original Estimated Enrollment
 (submitted: July 15, 2011)
3000
Actual Study Completion Date May 2014
Actual Primary Completion Date May 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

Patients prescribed with the vaccine

Exclusion Criteria:

Patients with hypersensitivity to the vaccine

Sex/Gender
Sexes Eligible for Study:All
Ages 6 Weeks and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Philippines
Removed Location Countries  
 
Administrative Information
NCT Number NCT01396434
Other Study ID Numbers B1851076
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Pfizer
Study Sponsor Pfizer
Collaborators Not Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date January 2016