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A Phase I/IIa Study of GC3110A (Quadrivalent Influenza Vaccine)

Primary Purpose

Influenza

Status
Completed
Phase
Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Quadrivalent influenza vaccine
Trivalent influenza vaccine
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 - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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)
  • 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

Experimental

Active Comparator

Arm Label

Quadrivalent influenza vaccine(Part A)

Quadrivalent influenza vaccine(Part B)

Trivalent influenza vaccine(Part B)

Arm Description

Day 1: GC3110A, 0.5ml, intramuscular, a single dosing

Day 1: GC3110A, 0.5ml, intramuscular, a single dosing

Day 1: GC Flu Pre-filled Syringe Inj., 0.5ml, intramuscular, a single dosing

Outcomes

Primary Outcome Measures

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
Seroconversion rate of HI (Hemagglutination Inhibition) antibody for each strain
Seroprotection rate of HI (Hemagglutination Inhibition) antibody for each strain

Secondary Outcome Measures

Abnormalities in physical examination, vital signs, and/or clinical laboratory tests
GMT(geometric mean titers) for each strain

Full Information

First Posted
April 22, 2014
Last Updated
August 12, 2014
Sponsor
Green Cross Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT02121782
Brief Title
A Phase I/IIa Study of GC3110A (Quadrivalent Influenza Vaccine)
Official Title
A Randomized, 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 GC3110A (Quadrivalent Influenza Vaccine)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2014
Overall Recruitment Status
Completed
Study Start Date
May 2014 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
June 2014 (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
The purpose of this study is to determine whether GC3110A (a QIV) is effective compared to GC Flu Pre-filled Syringe Inj. (a marketed TIV) after single intramuscular administration in Korean healthy adults. The comparator, GC Flu pre-filled syringe inj. is a trivalent influenza vaccine (TIV) including viruses representing 3 influenza strains (one A/HIN1, one A/H3N2, and one B). However, two antigenically distinct lineages of influenza B (Victoria and Yamagata) co-circulate annually in the United States. Predicting which lineage of influenza B will predominate during a season is challenging, and cross-protection by immunization against the other lineage is expected to be low. One proposed alternative is to produce a quadrivalent influenza vaccine (QIV) including an influenza B virus from each of the two circulating lineages. GC3110A is a new quadrivalent influenza vaccine (QIV), which contains all of 4 vaccine components WHO recommends for use in the 2013-14 influenza season (northern hemisphere winter) and includes two influenza B viruses. GC3110A is expected to show the additional public health benefit compared with traditional TIV.
Detailed Description
This study is the first in human trial of GC3110A 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. 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'.

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 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
84 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Quadrivalent influenza vaccine(Part A)
Arm Type
Experimental
Arm Description
Day 1: GC3110A, 0.5ml, intramuscular, a single dosing
Arm Title
Quadrivalent influenza vaccine(Part B)
Arm Type
Experimental
Arm Description
Day 1: GC3110A, 0.5ml, intramuscular, a single dosing
Arm Title
Trivalent influenza vaccine(Part B)
Arm Type
Active Comparator
Arm Description
Day 1: GC Flu Pre-filled Syringe Inj., 0.5ml, intramuscular, a single dosing
Intervention Type
Biological
Intervention Name(s)
Quadrivalent influenza vaccine
Other Intervention Name(s)
GC3110A
Intervention Description
GC3110A, 0.5ml, intramuscular, a single dosing at Day 1
Intervention Type
Biological
Intervention Name(s)
Trivalent influenza vaccine
Other Intervention Name(s)
GC Flu Pre-filled Syringe Inj.
Intervention Description
GC Flu Pre-filled Syringe Inj., 0.5ml, intramuscular, a single dosing at Day 1
Primary Outcome Measure Information:
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
Day 1 up to 7 Days 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
Day 1 up to 22 Days post vaccination
Title
Seroconversion rate of HI (Hemagglutination Inhibition) antibody for each strain
Time Frame
Day 22 post vaccination
Title
Seroprotection rate of HI (Hemagglutination Inhibition) antibody for each strain
Time Frame
Day 22 post vaccination
Secondary Outcome Measure Information:
Title
Abnormalities in physical examination, vital signs, and/or clinical laboratory tests
Time Frame
Day 22 post vaccination
Title
GMT(geometric mean titers) for each strain
Time Frame
Day 22 post vaccination

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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) 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
Woo Joo KIM, M.D., Ph.D.
Organizational Affiliation
Korea University Guro Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Chang-Hee Lee, M.D.
Organizational Affiliation
Green Cross Corporation
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 Phase I/IIa Study of GC3110A (Quadrivalent Influenza Vaccine)

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