Clinical trial NCT02249221: Safety, Tolerability, and Immunogenicity of GC3106 (Quadrivalent Cell-culture Based Influenza Vaccine)
Official title: A Randomized (Part B), Open-label (Part A) or Double-blind (Part B), Active-controlled (Part B) Phase I/IIa Study to Investigate the Safety, Tolerability, and Immunogenicity of GC3106 (Quadrivalent Cell-culture Based Influenza Vaccine)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Influenza
Keywords: Influenza vaccine
Vaccination
cell-culture based influenza vaccine
cell culture derived influenza vaccine
CCIV
Lead sponsor: GC Biopharma Corp
Sponsor class: INDUSTRY
First posted: 2014-09-25
Enrollment: 84
Sex: ALL
Minimum age (years): 19
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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'.

Eligibility criteria: 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

Primary outcomes:
measure: Solicited adverse events following vaccination
timeFrame: Day 1 up to 7 Days post vaccination
measure: Unsolicited adverse events following vaccination
timeFrame: Day 1 up to 22 Days post vaccination
measure: Abnormalities in physical examination, vital signs, and/or clinical laboratory tests
timeFrame: Day 22 post vaccination
Secondary outcomes:
measure: Seroprotection rate of HI (Hemagglutination Inhibition) antibody for each strain
timeFrame: Day 22 post vaccination
measure: Seroconversion rate of HI (Hemagglutination Inhibition) antibody for each strain
timeFrame: Day 22 post vaccination
measure: GMT(geometric mean titers) for each strain
timeFrame: Day 22 post vaccination
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital
Study officials:
affiliation: Korea University Guro Hospital
name: Woo Joo KIM, M.D., Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Green Cross Corporation
name: Chang-Hee LEE, M.D.
role: STUDY_DIRECTOR
References: