Clinical trial NCT02352584: A Multicenter, Double-blind, Parallel Phase III Study
Official title: A Multicenter, Randomized, Double-blind, Active-controlled, Parallel Phase III Study to Investigate the Efficacy(Immunogenicity) and Safety of GC3110A(Quadrivalent Influenza Vaccine)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Influenza
Keywords: QIV
Quadrivalent Influenza Vaccine
Influenza vaccine
Vaccination
Lead sponsor: GC Biopharma Corp
Sponsor class: INDUSTRY
First posted: 2015-02-02
Enrollment: 1299
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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

Eligibility 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

Primary outcomes:
measure: GMT rate of HI(Hemagglutination Inhibition) antibody for each strain
timeFrame: Day 21 post vaccination
measure: Solicited adverse events following vaccination
timeFrame: Day0 up to 21 Day post vaccination
measure: Unsolicited adverse events following vaccination
timeFrame: Day0 up to 21 Day post vaccination
measure: SCR rate of HI(Hemagglutination Inhibition) antibody for each strain
timeFrame: Day 21 post vaccination
Secondary outcomes:
measure: SCR rate of HI(Hemagglutination Inhibition) antibody for each strain
timeFrame: Day0 up to 21 Day post vaccination
measure: SPR rate of HI(Hemagglutination Inhibition) antibody
timeFrame: Day 21 post vaccination
measure: GMT rate of HI(Hemagglutination Inhibition) antibody for each strain
timeFrame: Day 21 post vaccination
measure: Abnormalities in physical examination, Vital signs, clinical laboratory tests
timeFrame: Day 21 post vaccination
measure: SAE
timeFrame: Day 180 post vaccination
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital
Study officials:
affiliation: Inha University Hospital
name: Lee Jin Su, M.D
role: STUDY_DIRECTOR
affiliation: Korea University Ansan Hospital
name: Choi Won Seck, M.D
role: STUDY_DIRECTOR
affiliation: Hallym Univ. Medical Center
name: Lee Ja Cob
role: STUDY_DIRECTOR
affiliation: Hallym Univ. Medical Center
name: Woo Heong Jung
role: STUDY_DIRECTOR
affiliation: St Vincent's Hospital
name: Wi Sung Heon
role: STUDY_DIRECTOR
affiliation: Chonnam Natinal University Hospital
name: Jeong Suk In
role: STUDY_DIRECTOR
affiliation: Kyungpook National University Hospital
name: Kim Sin Woo
role: STUDY_DIRECTOR
affiliation: Soon Chun Hyang Univ. Hospital
name: Kim Tae Hyung
role: STUDY_DIRECTOR
References: