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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: June 14, 2013
Last verified: June 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Healthy
 Biological: 13-valent pneumococcal vaccine
 Phase 4

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Post Marketing Surveillance to Observe Safety of Prevenar 13

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Frequency of any adverse event after immunization with Prevenar13 at a routine clinical setting [ Time Frame: 7days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 600
Study Start Date: September 2011
Estimated Study Completion Date: March 2016
Estimated Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Group1 Biological: 13-valent pneumococcal vaccine
0.5mL IM (Intramuscular administration) as per recommended schedule
Other Name: Prevenar 13

Detailed Description:

non-randomization, non-probability sampling

  Eligibility

Ages Eligible for Study:   6 Weeks to 5 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

All infants and children meeting the usual prescribing criteria for Prevenar 13 as per the local product information for usage

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01509105

Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
To obtain contact information for a study center near you, click here.  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01509105     History of Changes
Other Study ID Numbers: 6096A1-4029, B1851057
Study First Received: September 30, 2011
Last Updated: June 14, 2013
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

ClinicalTrials.gov processed this record on June 18, 2013