A Multicenter, Double-blind, Parallel Phase III Study

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

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1299 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-31

Study Completion Date

2015-07-31

Brief Summary

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

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Detailed Description

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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

Conditions

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Influenza

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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GC3110A(Quadrivalent)

0.5ml, intramuscular, a single dosing

Group Type EXPERIMENTAL

GC3110A(Quadrivalent)

Intervention Type BIOLOGICAL

GC3110A(Quadrivalent), 0.5ml, intramuscular, a single dosing at Day 1

GC Flu (Trivalent)

0.5ml,intramuscular,a single dosing

Group Type ACTIVE_COMPARATOR

GC Flu(Trivalent)

Intervention Type BIOLOGICAL

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

GC3110A(Trivalent)

0.5ml,intramuscular,a single dosing

Group Type ACTIVE_COMPARATOR

GC3110A(Trivalent)

Intervention Type BIOLOGICAL

GC3110A(Trivalent), 0.5ml, intramuscular, a single dosing at Day 1

Interventions

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GC3110A(Quadrivalent)

GC3110A(Quadrivalent), 0.5ml, intramuscular, a single dosing at Day 1

Intervention Type BIOLOGICAL

GC Flu(Trivalent)

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

Intervention Type BIOLOGICAL

GC3110A(Trivalent)

GC3110A(Trivalent), 0.5ml, intramuscular, a single dosing at Day 1

Intervention Type BIOLOGICAL

Other Intervention Names

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GC3110A GC Flu Pre-filled Syringe Inj. GC3110A

Eligibility Criteria

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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

Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes