A Multicenter, Double-blind, Parallel Phase III Study

Influenza Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02352584
• Other study ID #: GC3110A_AD_P3
• 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

• Influenza
• Influenza, Human

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