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Prevenar13 Post Market Surveillance

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NCT01509105

Last updated on April 11, 2018
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FOR MORE INFORMATION
Study Location
Choi's Pediatric Clinic
Wonju-si, Gangwon-do, 220-956 Korea, Republic of
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
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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Pfizer Clinical Trials Contact Center

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[email protected]

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Prevenar13 Post Market Surveillance
Post Marketing Surveillance To Observe Safety Of Prevenar 13
It 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.
non-randomization, non-probability sampling
Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample
All infants and children meeting the usual prescribing criteria for Prevenar 13 as per the local product information for usage
Healthy
Biological: 13-valent pneumococcal vaccine
0.5mL IM (Intramuscular administration) as per recommended schedule
Other Name: Prevenar 13
Group1
Intervention: Biological: 13-valent pneumococcal vaccine
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
649
January 2016
January 2016   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
6 Weeks to 17 Years   (Child)
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
 
NCT01509105
6096A1-4029
B1851057 ( Other Identifier: Alias Study Number )
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
December 2016

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



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