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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02352584
Other study ID # GC3110A_AD_P3
Secondary ID
Status Completed
Phase Phase 3
First received January 13, 2015
Last updated October 18, 2015
Start date October 2014
Est. completion date July 2015

Study information

Verified date October 2015
Source Green Cross Corporation
Contact n/a
Is FDA regulated No
Health authority Korea: Ministry of Food and Drug Safety
Study type Interventional

Clinical Trial Summary

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


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


Recruitment information / eligibility

Status Completed
Enrollment 1299
Est. completion date July 2015
Est. primary completion date December 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 19 Years and older
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Biological:
GC3110A(Quadrivalent)
GC3110A(Quadrivalent), 0.5ml, intramuscular, a single dosing at Day 1
GC Flu(Trivalent)
GC Flu Pre-filled Syringe Inj.(Trivalent), 0.5ml, intramuscular, a single dosing at Day 1
GC3110A(Trivalent)
GC3110A(Trivalent), 0.5ml, intramuscular, a single dosing at Day 1

Locations

Country Name City State
Korea, Republic of Korea University Guro Hospital Seoul

Sponsors (1)

Lead Sponsor Collaborator
Green Cross Corporation

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary GMT rate of HI(Hemagglutination Inhibition) antibody for each strain GMT (Active comparator) / GMT(Experimental) Day 21 post vaccination No
Primary 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 Yes
Primary 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 Yes
Primary SCR rate of HI(Hemagglutination Inhibition) antibody for each strain Difference of SCR (Experimental and Active comparator) Day 21 post vaccination No
Secondary SCR rate of HI(Hemagglutination Inhibition) antibody for each strain Day0 up to 21 Day post vaccination No
Secondary SPR rate of HI(Hemagglutination Inhibition) antibody Day 21 post vaccination No
Secondary GMT rate of HI(Hemagglutination Inhibition) antibody for each strain Day 21 post vaccination No
Secondary Abnormalities in physical examination, Vital signs, clinical laboratory tests Day 21 post vaccination Yes
Secondary SAE Day 180 post vaccination Yes
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