Safety and Immunogenicity Study of Tetanus, Diphtheria and Acellular Pertussis (Tdap) Vaccine
NCT ID: NCT02813486
Last Updated: 2016-11-07
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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UNKNOWN
PHASE1/PHASE2
220 participants
INTERVENTIONAL
2016-06-30
2016-11-30
Brief Summary
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Detailed Description
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To evaluate safety (solicited adverse events) of GC3111 in healthy adults.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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GC3111 Vaccine Group
Participants randomized to receive a single dose of GC3111 vaccine (Biological: GC3111 vaccine).
Biological: GC3111 vaccine
0.5mL, Intramuscular
Boostrix® Vaccine Group
Participants randomized to receive a single dose of Boostrix® vaccine (Biological: Boostrix® vaccine).
Biological: Boostrix® vaccine
0.5mL, Intramuscular
Interventions
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Biological: GC3111 vaccine
0.5mL, Intramuscular
Biological: Boostrix® vaccine
0.5mL, Intramuscular
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Informed consent and assent forms have been signed and dated
Exclusion Criteria
* Subject is pregnant, or lactating, or of child bearing potential without using an effective method of contraception or not practicing abstinence
* Receipt of any vaccine within 30 days before receiving study vaccine
* Any condition that, in the opinion of the Investigator, might interfere with the ability to comply with trial procedures.
19 Years
64 Years
ALL
Yes
Sponsors
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Green Cross Corporation
INDUSTRY
Responsible Party
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Locations
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Incheon St. Mary's Hospital Catholic Univ.
Incheon, Bupyeong 6-dong, Bupyeong-gu,, South Korea
The Catholic Univ. of Korea Daejeon St.Mary's Hospital
Daejeon, Jung-Gu, South Korea
The Catholic Univ.of Korea Bucheon St.Mary's Hospital
Gyeonggi-do, , South Korea
The Catholic Univ.of Korea Uijeongbu St.Mary's Hospital
Gyeonggi-do, , South Korea
The Catholic Univ.of Korea Yeouido St.Mary's Hospital
Seoul, , South Korea
Countries
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Other Identifiers
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GC3111_P1/2a
Identifier Type: -
Identifier Source: org_study_id