Immunogenicity and Safety Study of NBP606 in Healthy Infants
NCT ID: NCT02201030
Last Updated: 2020-04-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
577 participants
INTERVENTIONAL
2014-09-06
2016-10-21
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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NBP606
13-valent pneumococcal conjugate vaccine
NBP606
A single intramuscular injection into the thigh
Prevnar13
13-valent pneumococcal conjugate vaccine
Prevnar13
A single intramuscular injection into the thigh
Interventions
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NBP606
A single intramuscular injection into the thigh
Prevnar13
A single intramuscular injection into the thigh
Eligibility Criteria
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Inclusion Criteria
* The LAR (Legally Authorized Representative) who understand the requirements of the study and voluntarily consent to participate in the study.
Exclusion Criteria
* Any confirmed or suspected immunosuppressive or immunodeficient conditions
* Coagulation disorder contraindicating IM(intramuscular) vaccination
* Subject has received any licensed vaccine(not including BCG and Hepatitis B)
* Participation to another study
42 Days
98 Days
ALL
Yes
Sponsors
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SK Chemicals Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Confidential Investigator
Role: PRINCIPAL_INVESTIGATOR
Clinical Research Center
Locations
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Confidential
Seoul, , South Korea
Countries
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Other Identifiers
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NBP606_PCVI_III_2013
Identifier Type: -
Identifier Source: org_study_id
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