Prevenar13 Post Market Surveillance

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01509105
First received: September 30, 2011
Last updated: June 22, 2016
Last verified: June 2016
  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: June 2011
Study Completion Date: January 2016
Primary Completion Date: January 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 17 Years   (Child)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

Locations
Korea, Republic of
Choi's Pediatric Clinic
Wonju-si, Gangwon-do, Korea, Republic of, 220-956
Seoul Children's Hospital
Osan, Gyeonggi-do, Korea, Republic of, 447-804
Bundang Pediatric Clinic
Seongnam-si, Gyeonggi-do, Korea, Republic of, 463-821
Teun Teun Pediatric clinic
Suwon-si, Gyeonggi-do, Korea, Republic of, 443-471
Namujungwon Women's Hospital
Yangju, Gyeonggi-do, Korea, Republic of, 482-050
Yonsei Pediatric Clinic
Yongin-si, Gyeonggi-do, Korea, Republic of, 448-508
Jaeil Alliance Pediatrics Clinic
Daegu, Korea, Republic of, 701847
Teun Teun Pediatric Clinic
Daegu, Korea, Republic of, 702886
Eulji University Hospital
Daejeon, Korea, Republic of, 302-799
Cha Bundang Medical Center, Cha University
Gyeonggi-do, Korea, Republic of, 463-712
Lee Ha Young Pediatrics
Incheon, Korea, Republic of, 402-852
JaMo Women's Hospital
Suyeong-gu, Korea, Republic of, 613-806
Ulsan University Hospital
Ulsan, Korea, Republic of, 682-714
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
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 22, 2016
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Additional relevant MeSH terms:
Heptavalent Pneumococcal Conjugate Vaccine
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 23, 2016