Influenza
Conditions
Keywords
Influenza vaccine, Vaccination, cell-culture based influenza vaccine, cell culture derived influenza vaccine, CCIV
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. Data and Safety Monitoring Board (DSMB) will review the solicited/unsolicited adverse events conditionally if any toxicity of Grade 3 or 4 has been reported during 7 days after vaccination from the first 9 healthy volunteers. Part B is a randomized (2:1), double-blind, active controlled study and a total of 75 volunteers will participate in this part. Adverse events assessment will be done according to the 'Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials'.
Interventions
BIOLOGICALQuadrivalent cell-culture based influenza vaccin
GC3106, 0.5ml, intramuscular, a single dosing at Day 1
BIOLOGICALTrivalent influenza vaccine
GC Flu Pre-filled Syringe Inj., 0.5ml, intramuscular, a single dosing at Day 1
Sponsors
Green Cross Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
19 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* 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 criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Solicited adverse events following vaccination | Day 1 up to 7 Days post vaccination | Solicited injection site reactions: Pain, Tenderness, Erythema, Redness, Induration, and Swelling; Solicited systemic reactions: Fever, Sweating, Chill, Nausea, Vomiting, Diarrhea, Headache, Fatigue, Myalgia, arthralgia. |
| Unsolicited adverse events following vaccination | Day 1 up to 22 Days post vaccination | It can be estimated by Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials |
| Abnormalities in physical examination, vital signs, and/or clinical laboratory tests | Day 22 post vaccination | — |
Secondary
| Measure | Time frame |
|---|---|
| Seroprotection rate of HI (Hemagglutination Inhibition) antibody for each strain | Day 22 post vaccination |
| Seroconversion rate of HI (Hemagglutination Inhibition) antibody for each strain | Day 22 post vaccination |
| GMT(geometric mean titers) for each strain | Day 22 post vaccination |
Countries
South Korea
Outcome results
None listed