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)

A Multicenter, Randomized, Double-blind, Active-controlled, Parallel Phase III

Study Overview

• Status: Completed
• Conditions: Influenza
• Intervention / Treatment: Biological: GC3110A(Quadrivalent); Biological: GC Flu(Trivalent); Biological: GC3110A(Trivalent)

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

• Study Type: Interventional
• Enrollment (Anticipated): 1299
• Phase: Phase 3

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Korea University Guro Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: GC3110A(Quadrivalent); 0.5ml, intramuscular, a single dosing	Biological: GC3110A(Quadrivalent); GC3110A(Quadrivalent), 0.5ml, intramuscular, a single dosing at Day 1; Other Names: GC3110A
Active Comparator: GC Flu (Trivalent); 0.5ml,intramuscular,a single dosing	Biological: GC Flu(Trivalent); GC Flu Pre-filled Syringe Inj.(Trivalent), 0.5ml, intramuscular, a single dosing at Day 1; Other Names: GC Flu Pre-filled Syringe Inj.
Active Comparator: GC3110A(Trivalent); 0.5ml,intramuscular,a single dosing	Biological: GC3110A(Trivalent); GC3110A(Trivalent), 0.5ml, intramuscular, a single dosing at Day 1; Other Names: GC3110A

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Green Cross Corporation
• Investigators: 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 record dates

Study Major Dates

• Study Start: October 1, 2014
• Primary Completion (Actual): December 1, 2014
• Study Completion (Actual): July 1, 2015

Study Registration Dates

• First Submitted: January 13, 2015
• First Submitted That Met QC Criteria: January 28, 2015
• First Posted (Estimate): February 2, 2015

Study Record Updates

• Last Update Posted (Estimate): October 20, 2015
• Last Update Submitted That Met QC Criteria: October 18, 2015
• Last Verified: October 1, 2015

More Information

Terms related to this study

• Keywords: Influenza vaccine; Vaccination; QIV; Quadrivalent Influenza Vaccine
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Orthomyxoviridae Infections; Influenza, Human
• Other Study ID Numbers: GC3110A_AD_P3