Status:
COMPLETED
Safety, Tolerability, and Immunogenicity of GC3106 (Quadrivalent Cell-culture Based Influenza Vaccine)
Lead Sponsor:
Green Cross Corporation
Conditions:
Influenza
Eligibility:
All Genders
19-65 years
Phase:
PHASE1
PHASE2
Brief Summary
The purpose of this study is to evaluate the safety, tolerability, and immunogenicity of GC3106 after single intramuscular administration in Korean healthy adults.
Detailed Description
This study is the first in human trial of GC3106 and is designed as an adaptive Phase I/IIa to ensure participants protection. Part A is an open-label and single arm study in 9 healthy volunteers. Dat...
Eligibility Criteria
Inclusion
- Given written informed consent
- Healthy Korean adults (age: between over 19 and under 65)
- Korean adults who agree with 21 days follow up after vaccination and good compliance to study procedures
- Those who are able to comply with the requirements for the study
Exclusion
- Inability in written/verbal communication
- Subjects who have participated in other interventional study within 30 days
- Alcohol or drug abuse within 6 months
- Heavy drinkers or subjects who do not agree to stop drinking for 3 days before vaccination and other 3 days after vaccination
- Who got the treatment of psychotropic drugs and narcotic analgesic drugs within 6 months of enrollment
- Hypersensitivity with drug or active ingredient
- Disorders in immune function
- History of Guillain-Barré syndrome
- Disease/medications which are likely to cause any severe bleeding
- Active infection or experience of fever (\>38.0 ℃) within 72 hours following vaccination
- Oral temperature \>38.0 ℃ at the vaccination day
- Erythema, tattoo, injury at shoulder (vaccination site)
- Influenza vaccination within 6months
- Any vaccination within 30 days
- Concomitant medications/therapy such as immunosuppressants or immune modifying drugs, systemic corticosteroids, immunoglobulins, blood or blood- derived products, or anti-cancer chemotherapy or radiation therapy within3 months
- Pregnant or breast-feeding women
- Clinically significant underlying diseases or medical history at investigator's discretion
Key Trial Info
Start Date :
October 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2014
Estimated Enrollment :
84 Patients enrolled
Trial Details
Trial ID
NCT02249221
Start Date
October 1 2014
End Date
November 1 2014
Last Update
December 5 2014
Active Locations (1)
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1
Korea University Guro Hospital
Seoul, South Korea