A Multicenter, Double-blind, Parallel Phase III Study
A Multicenter, Randomized, Double-blind, Active-controlled, Parallel Phase III Study to Investigate the Efficacy(Immunogenicity) and Safety of GC3110A(Quadrivalent Influenza Vaccine)
1 other identifier
interventional
1,299
1 country
1
Brief Summary
A Multicenter, Randomized, Double-blind, Active-controlled, Parallel Phase III
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Oct 2014
Shorter than P25 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2014
CompletedFirst Submitted
Initial submission to the registry
January 13, 2015
CompletedFirst Posted
Study publicly available on registry
February 2, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2015
CompletedOctober 20, 2015
October 1, 2015
2 months
January 13, 2015
October 18, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
GMT rate of HI(Hemagglutination Inhibition) antibody for each strain
GMT (Active comparator) / GMT(Experimental)
Day 21 post vaccination
Solicited adverse events following 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
Day0 up to 21 Day post vaccination
Unsolicited adverse events following vaccination
It can be estimated by Toxicity Grading Scale for healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials
Day0 up to 21 Day post vaccination
SCR rate of HI(Hemagglutination Inhibition) antibody for each strain
Difference of SCR (Experimental and Active comparator)
Day 21 post vaccination
Secondary Outcomes (5)
SCR rate of HI(Hemagglutination Inhibition) antibody for each strain
Day0 up to 21 Day 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
SAE
Day 180 post vaccination
Study Arms (3)
GC3110A(Quadrivalent)
EXPERIMENTAL0.5ml, intramuscular, a single dosing
GC Flu (Trivalent)
ACTIVE COMPARATOR0.5ml,intramuscular,a single dosing
GC3110A(Trivalent)
ACTIVE COMPARATOR0.5ml,intramuscular,a single dosing
Interventions
GC3110A(Quadrivalent), 0.5ml, intramuscular, a single dosing at Day 1
GC Flu Pre-filled Syringe Inj.(Trivalent), 0.5ml, intramuscular, a single dosing at Day 1
GC3110A(Trivalent), 0.5ml, intramuscular, a single dosing at Day 1
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Korea University Guro Hospital
Seoul, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Lee Jin Su, M.D
Inha University Hospital
- STUDY DIRECTOR
Choi Won Seck, M.D
Korea University Ansan Hospital
- STUDY DIRECTOR
Lee Ja Cob
Hallym Univ. Medical Center
- STUDY DIRECTOR
Woo Heong Jung
Hallym Univ. Medical Center
- STUDY DIRECTOR
Wi Sung Heon
St Vincent's Hospital
- STUDY DIRECTOR
Jeong Suk In
Chonnam Natinal University Hospital
- STUDY DIRECTOR
Kim Sin Woo
Kyungpook National University Hospital
- STUDY DIRECTOR
Kim Tae Hyung
Soon Chun Hyang Univ. Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 13, 2015
First Posted
February 2, 2015
Study Start
October 1, 2014
Primary Completion
December 1, 2014
Study Completion
July 1, 2015
Last Updated
October 20, 2015
Record last verified: 2015-10