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
  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
Healthy
Biological: 13-valent pneumococcal vaccine

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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
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: September 10, 2014
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

ClinicalTrials.gov processed this record on October 23, 2014