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

Influenza Clinical Trial

Official title:

A Randomized (Part B), 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 GC3106 (Quadrivalent Cell-culture Based Influenza Vaccine)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02249221
• Other study ID #: GC3106_P1/2a
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: September 23, 2014
• Last updated: December 4, 2014
• Start date: October 2014
• Est. completion date: November 2014

Study information

• Verified date: December 2014
• 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

The purpose of this study is to evaluate the safety, tolerability, and immunogenicity of GC3106 after single intramuscular administration in Korean healthy adults.

Description:

This study is the first in human trial of GC3106 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 from the first 9 healthy volunteers. 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'.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: November 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 19 Years to 65 Years

Eligibility

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)

• 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, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Influenza
• Influenza, Human

Intervention

Biological:
• Quadrivalent cell-culture based influenza vaccin
GC3106, 0.5ml, intramuscular, a single dosing at Day 1
• Trivalent influenza vaccine
GC Flu Pre-filled Syringe Inj., 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	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.	Day 1 up to 7 Days 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	Day 1 up to 22 Days post vaccination	Yes
Primary	Abnormalities in physical examination, vital signs, and/or clinical laboratory tests		Day 22 post vaccination	Yes
Secondary	Seroprotection rate of HI (Hemagglutination Inhibition) antibody for each strain		Day 22 post vaccination	No
Secondary	Seroconversion rate of HI (Hemagglutination Inhibition) antibody for each strain		Day 22 post vaccination	No
Secondary	GMT(geometric mean titers) for each strain		Day 22 post vaccination	No