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Prevenar13 Post Market Surveillance

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01509105
First received: September 30, 2011
Last updated: September 10, 2014
Last verified: September 2014

September 30, 2011
September 10, 2014
September 2011
March 2016   (final data collection date for primary outcome measure)
Frequency of any adverse event after immunization with Prevenar13 at a routine clinical setting [ Time Frame: 7days ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01509105 on ClinicalTrials.gov Archive Site
  • Duration, severity of the adverse event [ Time Frame: 7days ] [ Designated as safety issue: Yes ]
  • Clinical outcome after the adverse event [ Time Frame: 7days ] [ Designated as safety issue: Yes ]
  • Discontinuation due to the adverse event [ Time Frame: 7days ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
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.
 
Enrolling by invitation
600
March 2016
March 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.
Both
6 Weeks to 5 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01509105
6096A1-4029, B1851057
No
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP