Prevenar13 Post Market Surveillance

NCT ID: NCT01509105

Last Updated: 2017-02-13

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

649 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-09-30

Study Completion Date

2016-01-31

Brief Summary

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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.

Detailed Description

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non-randomization, non-probability sampling

Conditions

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Healthy

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Group1

13-valent pneumococcal vaccine

Intervention Type BIOLOGICAL

0.5mL IM (Intramuscular administration) as per recommended schedule

Interventions

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13-valent pneumococcal vaccine

0.5mL IM (Intramuscular administration) as per recommended schedule

Intervention Type BIOLOGICAL

Other Intervention Names

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Prevenar 13

Eligibility Criteria

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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.
Minimum Eligible Age

6 Weeks

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Choi's Pediatric Clinic

Wŏnju, Gangwon-do, South Korea

Site Status

Seoul Children's Hospital

Osan, Gyeonggi-do, South Korea

Site Status

Bundang Pediatric Clinic

Seongnam-si, Gyeonggi-do, South Korea

Site Status

Teun Teun Pediatric clinic

Suwon, Gyeonggi-do, South Korea

Site Status

Namujungwon Women's Hospital

Yangju, Gyeonggi-do, South Korea

Site Status

Yonsei Pediatric Clinic

Yongin-si, Gyeonggi-do, South Korea

Site Status

Busan National University Hospital

Busan, , South Korea

Site Status

Jaeil Alliance Pediatrics Clinic

Daegu, , South Korea

Site Status

Teun Teun Pediatric Clinic

Daegu, , South Korea

Site Status

Eulji University Hospital

Daejeon, , South Korea

Site Status

Korea University Ansan Hospital

Gyeonggi-do, , South Korea

Site Status

Cha Bundang Medical Center, Cha University

Gyeonggi-do, , South Korea

Site Status

Inha University Hospital

Incheon, , South Korea

Site Status

Lee Ha Young Pediatrics

Incheon, , South Korea

Site Status

Asan Medical Center

Seoul, , South Korea

Site Status

Eulji Medical Center

Seoul, , South Korea

Site Status

JaMo Women's Hospital

Suyeong-gu, , South Korea

Site Status

Ulsan University Hospital

Ulsan, , South Korea

Site Status

Countries

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South Korea

Related Links

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Other Identifiers

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B1851057

Identifier Type: OTHER

Identifier Source: secondary_id

6096A1-4029

Identifier Type: -

Identifier Source: org_study_id

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