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Prevenar13 Post Market Surveillance

Last updated on October 11, 2019

FOR MORE INFORMATION
Study Location
Choi's Pediatric Clinic
Wonju-si, Gangwon-do, 220-956 Korea, Republic of
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Healthy
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
6-17 weeks
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Infants and children aged 6 weeks to 5 years, whose legally authorized representatives
of patients agree to provide written informed consent form (data privacy statement).

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

- Infants and children who are not indicated and/or contraindicated for the Prevenar13
usage will not be included.

NCT01509105
Pfizer
Completed
Prevenar13 Post Market Surveillance

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Descriptive Information
Brief TitlePrevenar13 Post Market Surveillance
Official TitlePost Marketing Surveillance To Observe Safety Of Prevenar 13
Brief SummaryIt is an observational multi-center study to assess the safety profile of Prevenar13 used among Korean children in the routine clinical setting following a licensure and introduction of the vaccine. This study is designed to fulfill regulatory requirement for any new drug authorized by KFDA.
Detailed Descriptionnon-randomization, non-probability sampling
Study TypeObservational
Study DesignObservational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up DurationNot Provided
BiospecimenNot Provided
Sampling MethodNon-Probability Sample
Study PopulationAll infants and children meeting the usual prescribing criteria for Prevenar 13 as per the local product information for usage
ConditionHealthy
InterventionBiological: 13-valent pneumococcal vaccine
0.5mL IM (Intramuscular administration) as per recommended schedule
Other Name: Prevenar 13
Study Groups/CohortsGroup1
Intervention: Biological: 13-valent pneumococcal vaccine
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 StatusCompleted
Actual Enrollment
 (submitted: December 20, 2016)
649
Original Estimated Enrollment
 (submitted: January 9, 2012)
600
Actual Study Completion DateJanuary 2016
Actual Primary Completion DateJanuary 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Infants and children aged 6 weeks to 5 years, whose legally authorized representatives of patients agree to provide written informed consent form (data privacy statement).

Exclusion Criteria:

  • Infants and children who are not indicated and/or contraindicated for the Prevenar13 usage will not be included.
Sex/Gender
Sexes Eligible for Study:All
Ages6 Weeks to 17 Years   (Child)
Accepts Healthy VolunteersNo
ContactsContact information is only displayed when the study is recruiting subjects
Listed Location CountriesKorea, Republic of
Removed Location Countries  
 
Administrative Information
NCT NumberNCT01509105
Other Study ID Numbers6096A1-4029
B1851057 ( Other Identifier: Alias Study Number )
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing StatementNot Provided
Responsible PartyPfizer
Study SponsorPfizer
CollaboratorsNot Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateDecember 2016

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

Call Now