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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

84 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-05-31

Study Completion Date

2014-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Safety, Tolerability, and Immunogenicity of GC3106 (Quadrivalent Cell-culture Based Influenza Vaccine)

NCT02249221

Influenza

COMPLETED PHASE1/PHASE2

A Study to Evaluate the Safety and Efficacy(Immunogenicity) of GC3114 in Healthy Adults

NCT03357263

Influenza, Human

COMPLETED PHASE1

A Study to Evaluate the Safety and Efficacy(Immunogenicity) of GC3114 in Elderly Healthy Subjects

NCT03657719

Influenza, Human

COMPLETED PHASE2

A Multicenter, Double-blind, Parallel Phase III Study

NCT02352584

Influenza

COMPLETED PHASE3

A Study to Evaluate the Efficacy and Safety of GC3110A in Healthy Subjects Aged 65 Years and Older

NCT02917304

Influenza, Human

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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'.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Influenza

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Quadrivalent influenza vaccine(Part A)

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

Group Type EXPERIMENTAL

Quadrivalent influenza vaccine

Intervention Type BIOLOGICAL

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

Quadrivalent influenza vaccine(Part B)

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

Group Type EXPERIMENTAL

Quadrivalent influenza vaccine

Intervention Type BIOLOGICAL

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

Trivalent influenza vaccine(Part B)

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

Group Type ACTIVE_COMPARATOR

Trivalent influenza vaccine

Intervention Type BIOLOGICAL

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Quadrivalent influenza vaccine

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

Intervention Type BIOLOGICAL

Trivalent influenza vaccine

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

Intervention Type BIOLOGICAL

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

GC3110A GC Flu Pre-filled Syringe Inj.

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

19 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes