Influenza
Conditions
Keywords
QIV, Quadrivalent Influenza Vaccine, Influenza vaccine, Vaccination
Brief summary
A Multicenter, Randomized, Double-blind, Active-controlled, Parallel Phase III
Detailed description
A Multicenter, Randomized, Double-blind, Active-controlled, Parallel Phase III Study to Investigate the Efficacy(Immunogenicity) and Safety of GC3110A(Quadrivalent Influenza Vaccine) After Intramuscular Administration in Healthy Subjects
Interventions
BIOLOGICALGC3110A(Quadrivalent)
GC3110A(Quadrivalent), 0.5ml, intramuscular, a single dosing at Day 1
BIOLOGICALGC Flu(Trivalent)
GC Flu Pre-filled Syringe Inj.(Trivalent), 0.5ml, intramuscular, a single dosing at Day 1
BIOLOGICALGC3110A(Trivalent)
GC3110A(Trivalent), 0.5ml, intramuscular, a single dosing at Day 1
Sponsors
Green Cross Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Criteria: Inclusion Criteria: * Given written informed consent * Healthy Korean adults (age: over 19 ) * 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 * Who got the treatment of psychotropic drugs and narcotic analgesic drugs within 6 months of enrollment * 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) * Hypersensitivity with egg, chicken, or any of the vaccine components, or Neomycin, Gentamicin * 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 |
|---|---|---|
| GMT rate of HI(Hemagglutination Inhibition) antibody for each strain | Day 21 post vaccination | GMT (Active comparator) / GMT(Experimental) |
| Solicited adverse events following vaccination | Day0 up to 21 Day 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 | Day0 up to 21 Day post vaccination | It can be estimated by Toxicity Grading Scale for healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials |
| SCR rate of HI(Hemagglutination Inhibition) antibody for each strain | Day 21 post vaccination | Difference of SCR (Experimental and Active comparator) |
Secondary
| Measure | Time frame |
|---|---|
| SCR rate of HI(Hemagglutination Inhibition) antibody for each strain | Day0 up to 21 Day post vaccination |
| SAE | Day 180 post vaccination |
| SPR rate of HI(Hemagglutination Inhibition) antibody | Day 21 post vaccination |
| GMT rate of HI(Hemagglutination Inhibition) antibody for each strain | Day 21 post vaccination |
| Abnormalities in physical examination, Vital signs, clinical laboratory tests | Day 21 post vaccination |
Countries
South Korea
Outcome results
None listed