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A Multicenter, Double-blind, Parallel Phase III Study

Primary Purpose

Influenza

Status
Completed
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
GC3110A(Quadrivalent)
GC Flu(Trivalent)
GC3110A(Trivalent)
Sponsored by
Green Cross Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Influenza focused on measuring QIV, Quadrivalent Influenza Vaccine, Influenza vaccine, Vaccination

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Korea University Guro Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

GC3110A(Quadrivalent)

GC Flu (Trivalent)

GC3110A(Trivalent)

Arm Description

0.5ml, intramuscular, a single dosing

0.5ml,intramuscular,a single dosing

0.5ml,intramuscular,a single dosing

Outcomes

Primary Outcome Measures

GMT rate of HI(Hemagglutination Inhibition) antibody for each strain
GMT (Active comparator) / GMT(Experimental)
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
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
SCR rate of HI(Hemagglutination Inhibition) antibody for each strain
Difference of SCR (Experimental and Active comparator)

Secondary Outcome Measures

SCR rate of HI(Hemagglutination Inhibition) antibody for each strain
SPR rate of HI(Hemagglutination Inhibition) antibody
GMT rate of HI(Hemagglutination Inhibition) antibody for each strain
Abnormalities in physical examination, Vital signs, clinical laboratory tests
SAE

Full Information

First Posted
January 13, 2015
Last Updated
October 18, 2015
Sponsor
Green Cross Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT02352584
Brief Title
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

2. Study Status

Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
October 2014 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
July 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Green Cross Corporation

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza
Keywords
QIV, Quadrivalent Influenza Vaccine, Influenza vaccine, Vaccination

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
1299 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
GC3110A(Quadrivalent)
Arm Type
Experimental
Arm Description
0.5ml, intramuscular, a single dosing
Arm Title
GC Flu (Trivalent)
Arm Type
Active Comparator
Arm Description
0.5ml,intramuscular,a single dosing
Arm Title
GC3110A(Trivalent)
Arm Type
Active Comparator
Arm Description
0.5ml,intramuscular,a single dosing
Intervention Type
Biological
Intervention Name(s)
GC3110A(Quadrivalent)
Other Intervention Name(s)
GC3110A
Intervention Description
GC3110A(Quadrivalent), 0.5ml, intramuscular, a single dosing at Day 1
Intervention Type
Biological
Intervention Name(s)
GC Flu(Trivalent)
Other Intervention Name(s)
GC Flu Pre-filled Syringe Inj.
Intervention Description
GC Flu Pre-filled Syringe Inj.(Trivalent), 0.5ml, intramuscular, a single dosing at Day 1
Intervention Type
Biological
Intervention Name(s)
GC3110A(Trivalent)
Other Intervention Name(s)
GC3110A
Intervention Description
GC3110A(Trivalent), 0.5ml, intramuscular, a single dosing at Day 1
Primary Outcome Measure Information:
Title
GMT rate of HI(Hemagglutination Inhibition) antibody for each strain
Description
GMT (Active comparator) / GMT(Experimental)
Time Frame
Day 21 post vaccination
Title
Solicited adverse events following vaccination
Description
Solicited injection site reactions: Pain, Tenderness, Erythema, Redness, Induration, and Swelling; Solicited systemic reactions: Fever, Sweating, Chill, Nausea, Vomiting, Diarrhea, Headache, Fatigue, Myalgia, Arthralgia
Time Frame
Day0 up to 21 Day post vaccination
Title
Unsolicited adverse events following vaccination
Description
It can be estimated by Toxicity Grading Scale for healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials
Time Frame
Day0 up to 21 Day post vaccination
Title
SCR rate of HI(Hemagglutination Inhibition) antibody for each strain
Description
Difference of SCR (Experimental and Active comparator)
Time Frame
Day 21 post vaccination
Secondary Outcome Measure Information:
Title
SCR rate of HI(Hemagglutination Inhibition) antibody for each strain
Time Frame
Day0 up to 21 Day post vaccination
Title
SPR rate of HI(Hemagglutination Inhibition) antibody
Time Frame
Day 21 post vaccination
Title
GMT rate of HI(Hemagglutination Inhibition) antibody for each strain
Time Frame
Day 21 post vaccination
Title
Abnormalities in physical examination, Vital signs, clinical laboratory tests
Time Frame
Day 21 post vaccination
Title
SAE
Time Frame
Day 180 post vaccination

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lee Jin Su, M.D
Organizational Affiliation
Inha University Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Choi Won Seck, M.D
Organizational Affiliation
Korea University Ansan Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Lee Ja Cob
Organizational Affiliation
Hallym Univ. Medical Center
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Woo Heong Jung
Organizational Affiliation
Hallym Univ. Medical Center
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Wi Sung Heon
Organizational Affiliation
St Vincent's Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Jeong Suk In
Organizational Affiliation
Chonnam Natinal University Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Kim Sin Woo
Organizational Affiliation
Kyungpook National University Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Kim Tae Hyung
Organizational Affiliation
Soon Chun Hyang Univ. Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Korea University Guro Hospital
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

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A Multicenter, Double-blind, Parallel Phase III Study

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