A Study to Evaluate the Efficacy and Safety of GC3110A in Healthy Subjects Aged 65 Years and Older
A Multicenter, Open-label, Single Arm Study to Evaluate the Immunological Efficacy and Safety of GC3110A. Administered Intramuscularly in Healthy Subjects Aged 65 Years and Older
1 other identifier
interventional
274
1 country
10
Brief Summary
The purpose of this study is to evaluate immunological efficacy and safety of GC3110A among healthy adults over 65 years of age.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Oct 2016
Shorter than P25 for phase_3
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 26, 2016
CompletedFirst Posted
Study publicly available on registry
September 28, 2016
CompletedStudy Start
First participant enrolled
October 10, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 2, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
May 8, 2017
CompletedMay 30, 2017
May 1, 2017
2 months
September 26, 2016
May 24, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Percentage of Participants Achieving Pre-defined Seroconversion Before and following vaccination
Percentage of Participants Achieving Pre-defined Seroconversion Before and following vaccination
Day 0 (Pre-Vaccination) and Day 21 (Post-Vaccination)
Percentage of Participants Achieving Pre-defined Seroprotection Before and following vaccination
Percentage of Participants Achieving Pre-defined Seroprotection Before and following vaccination
Day 0 (Pre-Vaccination) and Day 21 (Post-Vaccination)
Secondary Outcomes (1)
Geometric Mean Titer and Geometric Mean Titer Ratios of Antibodies to the GC3110A Before and Following Vaccination
Day 0 (Pre-Vaccination) and Day 21 (Post-Vaccination)
Study Arms (1)
GC3110A vaccine group
EXPERIMENTALParticipants administered a single dose of GC3110A(Quadrivalent Influenza Vaccine).
Interventions
Eligibility Criteria
You may qualify if:
- Healthy adults aged 65 years and older
- Informed consent form has been signed and dated
- Able to comply with the requirements of the study
You may not qualify if:
- Known systemic hypersensitivity to eggs, chicken proteins, or any of the vaccine components
- Personal history of Guillain-Barre syndrome(GBS)
- Subjects with severe chronic disease who are considered by investigator to be ineligible for the study
- Subjects who received a vaccination within 28 days before enrollment or who are scheduled for another vaccination during the study
- Immunocompromised subjects with immunodeficiency disease or subjects receiving immunosuppressive or immunomodulating therapy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (10)
The Catholic Univ. of Korea Daejeon St.Mary's Hospital
Daejeon, South Korea
Soon Chun Hyang University Bucheon Hospital
Gyeonggi-do, 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
EWHA woman's university mokdong hospital
Seoul, South Korea
KyungHee University Medical Center
Seoul, South Korea
Soon Chun Hyang University Seoul Hospital
Seoul, South Korea
The Catholic Univ. of Korea Incheon St.Mary's Hospital
Seoul, South Korea
The Catholic Univ.of Korea Seoul St.Mary's Hospital
Seoul, South Korea
The Catholic Univ.of Korea Yeouido St.Mary's Hospital
Seoul, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 26, 2016
First Posted
September 28, 2016
Study Start
October 10, 2016
Primary Completion
December 2, 2016
Study Completion
May 8, 2017
Last Updated
May 30, 2017
Record last verified: 2017-05
Data Sharing
- IPD Sharing
- Will not share